Edentulous Alveolar RidgeNCT05081284
Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix
A study testing Volume-stable collagen matrix Geistlich Fibro-Gide® in people with Edentulous Alveolar Ridge, run by University of Pisa at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the soft tissue clinical results in patients that received, or not, a soft tissue augmentation around dental implant inserted immediately after the extraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Volume-stable collagen matrix Geistlich Fibro-Gide®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a single failing tooth in the esthetic region (second premolar to contralateral second premolar), the adjacent teeth should be present and without any dental pathologies.
Who cannot join
- Patients who are heavy smokers (more than 10 cigarettes/day);
- Patients who suffer from any systemic diseases that could negatively influence wound healing;
- Patients who received head and neck radiation treatment;
- Patients who have a full contraindication to implant surgery;
- Patients who have uncontrolled periodontal disease;
- Patients who show a full mouth plaque and bleeding score higher than 25%;
Show all 9Show fewer
- Patients who have deficient extraction sockets according to the classification of Juodzbalys et al. 2008.
- Patients with known allergy, sensitivity or intolerance to collagen
- Patients who are pregnant or who are breastfeeding
Trial locations and contacts
1 site in 1 country.
Italy1 site
U.O. Odontostomatologia e Chirurgia del Cavo Orale
Pisa, Italy, 56126
About this study
Official title: Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix: a Randomized Controlled Clinical Trial
The purpose of this study is to evaluate the soft tissue clinical results in patients that received, or not, a soft tissue augmentation around dental implant inserted immediately after the extraction.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determinate eligibility for study entry. Patients who meet eligibility requirements will be randomized in this single blinded(investigator) study.
Group (Test) will receive immediate implant after extraction and a soft tissue augmentation with a collagen matrix.
Group (Control) will receive only immediate implant after extraction without soft tissue augmentation.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Volume-stable collagen matrix Geistlich Fibro-Gide®
- Keywords
- Soft tissue augmentation, Immediate implant, Collagen matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume-stable collagen matrix Geistlich Fibro-Gide®Device
Also called Geistlich Fibro-Gide, G1 039446 0086 Rev. 00 G7 16 07 39446 073
After tooth extraction and implant insertion the Test group will receive a soft tissue augmentation on the buccal side oh the implant. an envelop flap will be raised and a volume-stable collagen graft will be stabilized with sutures.
Control group will not receive soft tissue augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix. After the surgical procedures, each implant will receive a healing abutment until prosthetic restorative procedures. |
| Test Group | Experimental | Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix, and then a volume-stable collagen matrix will be buccally inserted with a split-thickness flap preparation. Subsequently, the collagen matrix graft will be stabilized with a horizontal mattress suture to the buccal flap. After the surgical procedures, each implant will receive healing abutment connection until the prosthetic restorative procedures Receives: Device: Volume-stable collagen matrix Geistlich Fibro-Gide® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft Tissue Thickness (STT)
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Measured: T0a: baseline before surgery
Soft Tissue Thickness (STT)
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Measured: T0b: baseline after surgery
Soft Tissue Thickness (STT)
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Measured: T2: 12 months after implant placement
Secondary outcomes (72)
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Measured: T0a: baseline before surgery
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Measured: T0b: baseline after surgery
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Measured: T2: 12 months after surgery
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Measured: T3: 24 months after surgery
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Measured: T4: 36 months after surgery
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Measured: T0a: baseline before surgery
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Measured: T2: 12 months after surgery
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Measured: T3: 24 months after surgery
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Measured: T4: 36 months after surgery
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Measured: T2: 12 months after surgery
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Measured: T3: 24 months after surgery
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Measured: T4: 36 months after surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Measured: T0a: baseline before surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Measured: T0b: baseline after surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Measured: T2: 12 months after surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Measured: T3: 24 months after surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Measured: T4: 36 months after surgery
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Measured: T0a: baseline before surgery
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Measured: T2: 12 months after surgery
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Measured: T3: 24 months after surgery
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Measured: T4: 36 months after surgery
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Measured: T0b: baseline after surgery
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Measured: T2: 12 months after surgery
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Measured: T3: 24 months after surgery
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Measured: T4: 36 months after surgery
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Measured: T0a: baseline before surgery
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Measured: T2: 12 months after surgery
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Measured: T3: 24 months after surgery
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Measured: T4: 36 months after surgery
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect. The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Measured: T0a: baseline before surgery
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Measured: T2: 12 months after surgery
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Measured: T3: 24 months after surgery
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Measured: T4: 36 months after surgery
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Measured: T0a: baseline before surgery
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Measured: T2: 12 months after surgery
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Measured: T3: 24 months after surgery
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Measured: T4: 36 months after surgery
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Measured: T0a: baseline before surgery
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Measured: T2: 12 months after surgery
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Measured: T3: 24 months after surgery
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Measured: T4: 36 months after surgery
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Measured: T2: 12 months after surgery
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Measured: T3: 24 months after surgery
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Measured: T4: 36 months after surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Measured: T0a: baseline before surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Measured: T0b: baseline after surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Measured: T2: 12 months after surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Measured: T3: 24 months after surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Measured: T4: 36 months after surgery
Surgery time
The surgery time will be recorded in both groups to the closest minute from the start of the first incision to the accomplishment of the last suture.
Measured: T0a-b: baseline
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade \& Spencer, 1994)
Measured: T0a: baseline before surgery
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade \& Spencer, 1994)
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade \& Spencer, 1994)
Measured: T2: 12 months after surgery
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade \& Spencer, 1994)
Measured: T3: 24 months after surgery
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade \& Spencer, 1994)
Measured: T4: 36 months after surgery
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Measured: T0a: baseline before surgery
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Measured: T1: 2 weeks after crown delivery, 4 months from surgery
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Measured: T2: 12 months after surgery
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Measured: T3: 24 months after surgery
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Measured: T4: 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start10 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Barone, University of Pisa
- Investigators
- Antonio Barone, DDS, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081284
- Sponsor's protocol ID
- 19228
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cairo F, Barbato L, Tonelli P, Batalocco G, Pagavino G, Nieri M. Xenogeneic collagen matrix versus connective tissue graft for buccal soft tissue augmentation at implant site. A randomized, controlled clinical trial. J Clin Periodontol. 2017 Jul;44(7):769-776. doi: 10.1111/jcpe.12750. Epub 2017 Jun 29.
PubMed 28548210Bittner N, Planzos L, Volchonok A, Tarnow D, Schulze-Spate U. Evaluation of Horizontal and Vertical Buccal Ridge Dimensional Changes After Immediate Implant Placement and Immediate Temporization With and Without Bone Augmentation Procedures: Short-Term, 1-Year Results. A Randomized Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2020 Jan/Feb;40(1):83-93. doi: 10.11607/prd.4152.
PubMed 31815977Zeltner M, Jung RE, Hammerle CH, Husler J, Thoma DS. Randomized controlled clinical study comparing a volume-stable collagen matrix to autogenous connective tissue grafts for soft tissue augmentation at implant sites: linear volumetric soft tissue changes up to 3 months. J Clin Periodontol. 2017 Apr;44(4):446-453. doi: 10.1111/jcpe.12697. Epub 2017 Feb 11.
PubMed 28107560Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
PubMed 16307569Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.
PubMed 9497723De Rouck T, Eghbali R, Collys K, De Bruyn H, Cosyn J. The gingival biotype revisited: transparency of the periodontal probe through the gingival margin as a method to discriminate thin from thick gingiva. J Clin Periodontol. 2009 May;36(5):428-33. doi: 10.1111/j.1600-051X.2009.01398.x.
PubMed 19419444Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.
PubMed 3507627Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.
PubMed 2099210Pjetursson BE, Thoma D, Jung R, Zwahlen M, Zembic A. A systematic review of the survival and complication rates of implant-supported fixed dental prostheses (FDPs) after a mean observation period of at least 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:22-38. doi: 10.1111/j.1600-0501.2012.02546.x.
PubMed 23062125van der Meulen MJ, Lobbezoo F, John MT, Naeije M. [Oral health impact profile. an instrument for measuring the impact of oral health on the quality of life]. Ned Tijdschr Tandheelkd. 2011 Mar;118(3):134-9. doi: 10.5177/ntvt.2011.03.10178. Dutch.
PubMed 21491763
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05081284
- Acronym / sponsor ID
- 19228
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- Soft tissue augmentation, Immediate implant, Collagen matrix
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the soft tissue clinical results in patients that received, or not, a soft tissue augmentation around dental implant inserted immediately after the extraction.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determinate eligibility for study entry. Patients who meet eligibility requirements will be randomized in this single blinded(investigator) study.
Group (Test) will receive immediate implant after extraction and a soft tissue augmentation with a collagen matrix.
Group (Control) will receive only immediate implant after extraction without soft tissue augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix. After the surgical procedures, each implant will receive a healing abutment until prosthetic restorative procedures. |
| Test Group | Experimental | Device: Volume-stable collagen matrix Geistlich Fibro-Gide®Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix, and then a volume-stable collagen matrix will be buccally inserted with a split-thickness flap preparation. Subsequently, the collagen matrix graft will be stabilized with a horizontal mattress suture to the buccal flap. After the surgical procedures, each implant will receive healing abutment connection until the prosthetic restorative procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of a single failing tooth in the esthetic region (second premolar to contralateral second premolar), the adjacent teeth should be present and without any dental pathologies.
Key exclusion criteria (9 listed)
- Patients who are heavy smokers (more than 10 cigarettes/day);
- Patients who suffer from any systemic diseases that could negatively influence wound healing;
- Patients who received head and neck radiation treatment;
- Patients who have a full contraindication to implant surgery;
- Patients who have uncontrolled periodontal disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume-stable collagen matrix Geistlich Fibro-Gide®Also: Geistlich Fibro-Gide, G1 039446 0086 Rev. 00 G7 16 07 39446 073After tooth extraction and implant insertion the Test group will receive a soft tissue augmentation on the buccal side oh the implant. an envelop flap will be raised and a volume-stable collagen graft will be stabilized with sutures. Control group will not receive soft tissue augmentation. | Device | Test Group |
Primary outcome
Soft Tissue Thickness (STT)
Time frame: T0a: baseline before surgery
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Soft Tissue Thickness (STT)
Time frame: T0b: baseline after surgery
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Soft Tissue Thickness (STT)
Time frame: T2: 12 months after implant placement
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
72 secondary outcomes
Vertical position of soft tissue (VPS)
Time frame: T0a: baseline before surgery
Vertical position of soft tissue (VPS)
Time frame: T0b: baseline after surgery
Vertical position of soft tissue (VPS)
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Vertical position of soft tissue (VPS)
Time frame: T2: 12 months after surgery
Vertical position of soft tissue (VPS)
Time frame: T3: 24 months after surgery
Vertical position of soft tissue (VPS)
Time frame: T4: 36 months after surgery
Assessment of the linear volumetric changes
Time frame: T0a: baseline before surgery
Assessment of the linear volumetric changes
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Assessment of the linear volumetric changes
Time frame: T2: 12 months after surgery
Assessment of the linear volumetric changes
Time frame: T3: 24 months after surgery
Assessment of the linear volumetric changes
Time frame: T4: 36 months after surgery
Pink Esthetic Score (PES)
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Pink Esthetic Score (PES)
Time frame: T2: 12 months after surgery
Pink Esthetic Score (PES)
Time frame: T3: 24 months after surgery
Pink Esthetic Score (PES)
Time frame: T4: 36 months after surgery
Papillae index (PI)
Time frame: T0a: baseline before surgery
Papillae index (PI)
Time frame: T0b: baseline after surgery
Papillae index (PI)
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Papillae index (PI)
Time frame: T2: 12 months after surgery
Papillae index (PI)
Time frame: T3: 24 months after surgery
Papillae index (PI)
Time frame: T4: 36 months after surgery
Width of keratinized tissue (WKT)
Time frame: T0a: baseline before surgery
Width of keratinized tissue (WKT)
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Width of keratinized tissue (WKT)
Time frame: T2: 12 months after surgery
Width of keratinized tissue (WKT)
Time frame: T3: 24 months after surgery
Width of keratinized tissue (WKT)
Time frame: T4: 36 months after surgery
Peri-implant marginal bone level (MBL)
Time frame: T0b: baseline after surgery
Peri-implant marginal bone level (MBL)
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Peri-implant marginal bone level (MBL)
Time frame: T2: 12 months after surgery
Peri-implant marginal bone level (MBL)
Time frame: T3: 24 months after surgery
Peri-implant marginal bone level (MBL)
Time frame: T4: 36 months after surgery
Phenotype
Time frame: T0a: baseline before surgery
Phenotype
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Phenotype
Time frame: T2: 12 months after surgery
Phenotype
Time frame: T3: 24 months after surgery
Phenotype
Time frame: T4: 36 months after surgery
Probing pocket depth (PD)
Time frame: T0a: baseline before surgery
Probing pocket depth (PD)
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Probing pocket depth (PD)
Time frame: T2: 12 months after surgery
Probing pocket depth (PD)
Time frame: T3: 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 28548210Cairo F, Barbato L, Tonelli P, Batalocco G, Pagavino G, Nieri M. Xenogeneic collagen matrix versus connective tissue graft for buccal soft tissue augmentation at implant site. A randomized, controlled clinical trial. J Clin Periodontol. 2017 Jul;44(7):769-776. doi: 10.1111/jcpe.12750. Epub 2017 Jun 29.
- Results publication: PubMed 31815977Bittner N, Planzos L, Volchonok A, Tarnow D, Schulze-Spate U. Evaluation of Horizontal and Vertical Buccal Ridge Dimensional Changes After Immediate Implant Placement and Immediate Temporization With and Without Bone Augmentation Procedures: Short-Term, 1-Year Results. A Randomized Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2020 Jan/Feb;40(1):83-93. doi: 10.11607/prd.4152.
- Results publication: PubMed 28107560Zeltner M, Jung RE, Hammerle CH, Husler J, Thoma DS. Randomized controlled clinical study comparing a volume-stable collagen matrix to autogenous connective tissue grafts for soft tissue augmentation at implant sites: linear volumetric soft tissue changes up to 3 months. J Clin Periodontol. 2017 Apr;44(4):446-453. doi: 10.1111/jcpe.12697. Epub 2017 Feb 11.
- Results publication: PubMed 16307569Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
- Results publication: PubMed 9497723Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.
- Results publication: PubMed 19419444De Rouck T, Eghbali R, Collys K, De Bruyn H, Cosyn J. The gingival biotype revisited: transparency of the periodontal probe through the gingival margin as a method to discriminate thin from thick gingiva. J Clin Periodontol. 2009 May;36(5):428-33. doi: 10.1111/j.1600-051X.2009.01398.x.
- Results publication: PubMed 3507627Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.
- Results publication: PubMed 2099210Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.
- Results publication: PubMed 23062125Pjetursson BE, Thoma D, Jung R, Zwahlen M, Zembic A. A systematic review of the survival and complication rates of implant-supported fixed dental prostheses (FDPs) after a mean observation period of at least 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:22-38. doi: 10.1111/j.1600-0501.2012.02546.x.
- Results publication: PubMed 21491763van der Meulen MJ, Lobbezoo F, John MT, Naeije M. [Oral health impact profile. an instrument for measuring the impact of oral health on the quality of life]. Ned Tijdschr Tandheelkd. 2011 Mar;118(3):134-9. doi: 10.5177/ntvt.2011.03.10178. Dutch.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Barone, DDS principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volume-stable collagen matrix Geistlich Fibro-Gide® in people with Edentulous Alveolar Ridge, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft Tissue Thickness (STT) (time frame: T0a: baseline before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05081284, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.