Alveolar Bone ResorptionGBR_socketNCT05577663
Guided Bone Regeneration in Alveolar Socket
A study testing Routine treatment of the extraction socket, Socket seal technique by a free gingival graft and Socket seal technique using a synthetic resorbable membrane in people with Alveolar Bone Resorption, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Following tooth extraction, volumetric changes in the soft and hard tissues of the extraction site are expected to occur with considerable resorption of the alveolar bone in both the vertical and the horizontal dimensions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- Routine treatment of the extraction socket, Socket seal technique by a free gingival graft and Socket seal technique using a synthetic resorbable membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteGreece
- Study dates
- 1 Oct 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Referrals for a single tooth extraction
- Periodontal destruction less than 50% of tooth support
- Signed inform consent form
Who cannot join
- Systematic diseases, contradicting surgical procedures and compromise wound healing (i.e. uncontrolled diabetes)
- Medication that interferes with bone metabolism
- Pregnancy or lactation
- Multiple extractions
- Absence of adjacent teeth
- Loss of buccal bone, either due to periodontal disease or because of traumatic extraction
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Dental School, Aristotle University, Dept of Preventive Dentistry, Periodontology and Implant Biology
Thessaloniki, 54124
Dane Apatzidou, Associate Professor, (+30) 2310 999584, dapatzidou@dent.auth.gr
Marilena Kalliopi Louvrou, PG Student, +306979360874, marilenal1994@gmail.com
About this study
Official title: Guided Bone Regeneration in Alveolar Socket Using a Synthetic Resorbable Membrane. a Randomized Controlled Trial
Following tooth extraction, volumetric changes in the soft and hard tissues of the extraction site are expected to occur with considerable resorption of the alveolar bone in both the vertical and the horizontal dimensions. These changes may complicate surgical implant placement and may also compromise the outcome of the prosthetic reconstruction. Various treatment approaches have been introduced aiming to preserve the dimensions of the alveolar ridge at the extraction site and facilitate optimal implant placement.
This prospective randomized controlled trial aims to determine the efficacy of alveolar ridge preservation utilizing two different socket seal approaches compared to spontaneous healing to stabilize the blood clot within the postextraction socket. Thirty-six subjects will be randomly allocated into one of the three treatment groups. Group-A: Extraction of the tooth and suturing of the extraction socket with resorbable suture PGA 5/0. Group-B: Extraction of the tooth and placement of a Free Gingival Graft stabilized with resorbable suture PGA 5/0. Group-C: Extraction of the tooth and placement of the Polylactic-Glycolic Acid membrane stabilized with resorbable suture PGA 5/0. After the initial examination for screening, subjects will be assessed at baseline-extraction day- and after 1, 2, and 6 weeks, and 3 months. The changes of the alveolar crest will be determined in height and width, in addition to volumetric changes in the soft tissues, and the width of keratinized tissues. The wound healing process will be visually assessed.
Read the detailed description
This prospective randomized controlled trial aims to determine the effectiveness of two different approaches of the "socket seal technique" for the preservation of the soft and hard tissues at the extraction site by utilizing a free gingival graft (FGG) or a PLGA membrane to stabilize the blood clot within the extraction socket compared with spontaneous healing of the tissues.
Primary outcome variable of the study will be alveolar bone changes in height buccally and palatally.
Secondary outcome variables: Alveolar bone changes in width, Mucosa thickness changes, Wound healing visual assessment, Width of keratinized tissues.
Materials and methods Thirty-six subjects will be randomly allocated into one of the three treatment groups based on computer-generated lists using a "block-design". Each patient contributes with one study site.
Study groups:
Group-A: Extraction of the tooth and suturing of the extraction socket with resorbable suture PGA 5/0.
Group-B: Extraction of the tooth, deepithelialization of the gingival colar of the socket, placement of a Free Gingival Graft taken from a standardized location of the palate adjusted to seal the socket opening and then stabilize it by resorbable suture PGA 5/0.
Group-C: Extraction of the tooth, retraction of mucoperiosteal flaps by 2 mm at the opening of the socket using a microsurgical elevator followed by adjustment of the Polylactic-Glycolic Acid membrane over the socket opening resting by 1 mm over the alveolar crest of the extraction socket. Tissues are sutured over the barrier by resorbable suture PGA 5/0.
Timeline of the study/Clinical procedures:
First visit - initial examination - (1 week before the surgery)
- Suitability of subjects
- Consent form; Randomization of the patient
- Radiographic examination (Long-cone paralleling technique using a digital sensor attached to a custom-made silicone bite block for reproducible radiographs)
- Intra-oral photography
- Impression of the examined area in order to create a reference stent to reproduce in a standard manner the clinical/radiographic measurements.
- Full mouth scaling; oral hygiene instructions
Second visit - Baseline - T0
- Clinical measurements with the use of the reference stent of: (i) The width of keratinized tissues with the use of a periodontal probe (Hu-Friedy XP-23/QW) (ii) The thickness of mucosa with the use of an ultrasonic device SDM (iii) The buccal osseous plate in relation to the gingival margin with a periodontal probe.
- Extraction of the tooth in a standardized way to minimize trauma; Post-surgical instructions will be given to the patient. Treatment of the extraction site accordingly to randomized treatment approach (Group-A, -B, -C). (i) Radiographic examination: (ii) Standardized intraoral x-ray and standardized CBCT (with the use of a reference stent)
Third visit - T1 - (1 week after the surgery)
- Evidence of healing
- Intra-oral photography
Fourth visit - T2 - (2 weeks after the surgery)
- Evidence of healing
- Removal of sutures
- Intra-oral photography
Fifth visit - T3 - Re-evaluation (6 weeks after the surgery)
- Intra-oral photography
- Width of keratinized tissues with the use of periodontal probe (Hu-Friedy XP-23/QW)
- Thickness of mucosa determined by the ultrasonic device SDM in the aforementioned standardized points with the use of the reference stent.
- Radiographic examination (The long-cone paralleling technique will be used at a distance of 10 cm between the X-ray head and the digital sensor which is attached to a custom-made silicone bite block for reproducible radiographs.)
Sixth visit - T4 - Final evaluation (3 months after the extraction)
- Intra-oral photography
- Record of periodontal plaque index (Pl) and bleeding on probing (BoP) at the adjacent teeth with the use of periodontal probe (Hu-Friedy XP-23/QW).
- Record of the width of keratinized tissues with the use of periodontal probe (Hu-Friedy XP-23/QW) and the thickness with the use of the ultrasonic device SDM in the aforementioned standardized points with the use of the reference stent.
- Radiographic examination with standardized intraoral x-ray and CBCT (with the use of the reference stent)
- Conditions
- Alveolar Bone Resorption
- Being tested
- Routine treatment of the extraction socket, Socket seal technique by a free gingival graft, Socket seal technique using a synthetic resorbable membrane
- Keywords
- socket seal, randomized controlled clinical trial, alveolar ridge preservation, polylactic-glycolic acid membrane, free gingival graft, spontaneous healing
- Medical subject headings
- Remission, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine treatment of the extraction socketOther
Suturing of the extraction socket with resorbable suture PGA 5/0 in order to protect the blood clot
Socket seal technique by a free gingival graftProcedure or surgery
Placement of a free gingival graft in the socket opening in order to protect and stabilize the blood clot followed by suturing
Socket seal technique using a synthetic resorbable membraneProcedure or surgery
Placement of a synthetic barrier in the socket opening in order to protect and stabilize the blood clot followed by suturing
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous healing | Other | Routine treatment of the extraction socket. Extraction of the tooth and suturing of the extraction socket with resorbable suture PGA 5/0 (polygalactic acid 5/0 sutures; PGA, medipac, Greece). Receives: Other: Routine treatment of the extraction socket |
| Free gingival graft | Active comparator | Extraction of the tooth, placement of a Free Gingival Graft taken from the palate and adjusted to seal the socket opening and stabilize it by resorbable sutures PGA 5/0 (polygalactic acid 5/0 sutures; PGA, medipac, Greece). Receives: Procedure: Socket seal technique by a free gingival graft |
| Polylactic-Glycolic Acid membrane | Experimental | Extraction of the tooth, adjustment of the Polylactic-Glycolic Acid membrane (PLGA,Tisseos®, Biomedical Tissues, Septodont, France) over the socket opening resting by 1 mm over the alveolar crest of the extraction socket. Tissues are sutured over the barrier by resorbable sutures PGA 5/0 (polygalactic acid 5/0 sutures; PGA, medipac, Greece). Receives: Procedure: Socket seal technique using a synthetic resorbable membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osseous changes in height of the alveolar ridge
The height of the alveolar ridge will be measured at standardized points distal, mesial and buccal/ palatal/ lingual at standardized points with the use of a reference stent by a CBCT.
Measured: Clinically: immediately after tooth extraction(baseline), 6 weeks and 3 months after the extraction. CBCT: immediately after the extraction and 3 months after the extraction
Osseous changes in width of the alveolar ridge
The width of the alveolar ridge will be measured distal, mesial and buccal/ palatal/ lingual at standardized points with the use of a reference stent by a CBCT.
Measured: Immediately after the extraction(baseline) and 3 months after the extraction
Secondary outcomes (3)
Mucosa thickness changes
The thickness of the keratinized tissues will be determined with the use of an ultrasonic device SDM (Austenal Medizintechnik, Koln, Germany) for recording soft tissue thickness at standardized points with the use of a reference stent.
Measured: Baseline, 6 weeks and 3 months after the extraction
Width of keratinized tissues
The width of the keratinized tissues will be determined on the buccal aspect by a manual periodontal probe (Hu-Friedy XP-23/QW) in a standardized way by the use of a reference stent at three time-points. All recordings will be transferred to a digital caliber
Measured: Baseline, 6 weeks and 3 months after the extraction
Wound healing
Visual assessment of healing
Measured: 1 and 2 weeks after the extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Oct 2022
- Primary completion30 Mar 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone ResorptionStudies 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
- Model description
- Randomised controlled clinical trial having 3 parallel intervention arms for alveolar ridge preservation and prevention of future alveolar bone resorption due to volumetric changes of tissues post-tooth extraction.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- University Paul Sabatier of Toulouse
- Responsible party
- Principal investigator, Danae A. Apatzidou, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577663
- Sponsor's protocol ID
- AUTh-79/13-02-2020
- Acronym
- GBR_socket
- Status last verified
- Apr 2024
- First submitted
- 10 Oct 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Overall data but not on an individual basis will be disclosed and shared
Publications
Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354Farmer M, Darby I. Ridge dimensional changes following single-tooth extraction in the aesthetic zone. Clin Oral Implants Res. 2014 Feb;25(2):272-7. doi: 10.1111/clr.12108. Epub 2013 Jan 25.
PubMed 23346895Maiorana C, Poli PP, Deflorian M, Testori T, Mandelli F, Nagursky H, Vinci R. Alveolar socket preservation with demineralised bovine bone mineral and a collagen matrix. J Periodontal Implant Sci. 2017 Aug;47(4):194-210. doi: 10.5051/jpis.2017.47.4.194. Epub 2017 Aug 11.
PubMed 28861284Prato GP, Cairo F, Tinti C, Cortellini P, Muzzi L, Mancini EA. Prevention of alveolar ridge deformities and reconstruction of lost anatomy: a review of surgical approaches. Int J Periodontics Restorative Dent. 2004 Oct;24(5):434-45. doi: 10.11607/prd.00.0602.
PubMed 15506024Jung RE, Siegenthaler DW, Hammerle CH. Postextraction tissue management: a soft tissue punch technique. Int J Periodontics Restorative Dent. 2004 Dec;24(6):545-53.
PubMed 15626317Annunziata M, Guida L, Nastri L, Piccirillo A, Sommese L, Napoli C. The Role of Autologous Platelet Concentrates in Alveolar Socket Preservation: A Systematic Review. Transfus Med Hemother. 2018 May;45(3):195-203. doi: 10.1159/000488061. Epub 2018 May 3.
PubMed 29928175
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Bone Regeneration in Alveolar Socket Using a Synthetic Resorbable Membrane. a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05577663
- Acronym / sponsor ID
- GBR_socket / AUTh-79/13-02-2020
- Conditions
- Alveolar Bone Resorption
- Keywords
- socket seal, randomized controlled clinical trial, alveolar ridge preservation, polylactic-glycolic acid membrane, free gingival graft, spontaneous healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- University Paul Sabatier of Toulouse
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 13 Oct 2022 (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.
Following tooth extraction, volumetric changes in the soft and hard tissues of the extraction site are expected to occur with considerable resorption of the alveolar bone in both the vertical and the horizontal dimensions. These changes may complicate surgical implant placement and may also compromise the outcome of the prosthetic reconstruction. Various treatment approaches have been introduced aiming to preserve the dimensions of the alveolar ridge at the extraction site and facilitate optimal implant placement.
This prospective randomized controlled trial aims to determine the efficacy of alveolar ridge preservation utilizing two different socket seal approaches compared to spontaneous healing to stabilize the blood clot within the postextraction socket. Thirty-six subjects will be randomly allocated into one of the three treatment groups. Group-A: Extraction of the tooth and suturing of the extraction socket with resorbable suture PGA 5/0. Group-B: Extraction of the tooth and placement of a Free Gingival Graft stabilized with resorbable suture PGA 5/0. Group-C: Extraction of the tooth and placement of the Polylactic-Glycolic Acid membrane stabilized with resorbable suture PGA 5/0. After the initial examination for screening, subjects will be assessed at baseline-extraction day- and after 1, 2, and 6 weeks, and 3 months. The changes of the alveolar crest will be determined in height and width, in addition to volumetric changes in the soft tissues, and the width of keratinized tissues. The wound healing process will be visually assessed.
Detailed description
This prospective randomized controlled trial aims to determine the effectiveness of two different approaches of the "socket seal technique" for the preservation of the soft and hard tissues at the extraction site by utilizing a free gingival graft (FGG) or a PLGA membrane to stabilize the blood clot within the extraction socket compared with spontaneous healing of the tissues.
Primary outcome variable of the study will be alveolar bone changes in height buccally and palatally.
Secondary outcome variables: Alveolar bone changes in width, Mucosa thickness changes, Wound healing visual assessment, Width of keratinized tissues.
Materials and methods Thirty-six subjects will be randomly allocated into one of the three treatment groups based on computer-generated lists using a "block-design". Each patient contributes with one study site.
Study groups:
Group-A: Extraction of the tooth and suturing of the extraction socket with resorbable suture PGA 5/0.
Group-B: Extraction of the tooth, deepithelialization of the gingival colar of the socket, placement of a Free Gingival Graft taken from a standardized location of the palate adjusted to seal the socket opening and then stabilize it by resorbable suture PGA 5/0.
Group-C: Extraction of the tooth, retraction of mucoperiosteal flaps by 2 mm at the opening of the socket using a microsurgical elevator followed by adjustment of the Polylactic-Glycolic Acid membrane over the socket opening resting by 1 mm over the alveolar crest of the extraction socket. Tissues are sutured over the barrier by resorbable suture PGA 5/0.
Timeline of the study/Clinical procedures:
First visit - initial examination - (1 week before the surgery)
- Suitability of subjects
- Consent form; Randomization of the patient
- Radiographic examination (Long-cone paralleling technique using a digital sensor attached to a custom-made silicone bite block for reproducible radiographs)
- Intra-oral photography
- Impression of the examined area in order to create a reference stent to reproduce in a standard manner the clinical/radiographic measurements.
- Full mouth scaling; oral hygiene instructions
Second visit - Baseline - T0
- Clinical measurements with the use of the reference stent of: (i) The width of keratinized tissues with the use of a periodontal probe (Hu-Friedy XP-23/QW) (ii) The thickness of mucosa with the use of an ultrasonic device SDM (iii) The buccal osseous plate in relation to the gingival margin with a periodontal probe.
- Extraction of the tooth in a standardized way to minimize trauma; Post-surgical instructions will be given to the patient. Treatment of the extraction site accordingly to randomized treatment approach (Group-A, -B, -C). (i) Radiographic examination: (ii) Standardized intraoral x-ray and standardized CBCT (with the use of a reference stent)
Third visit - T1 - (1 week after the surgery)
- Evidence of healing
- Intra-oral photography
Fourth visit - T2 - (2 weeks after the surgery)
- Evidence of healing
- Removal of sutures
- Intra-oral photography
Fifth visit - T3 - Re-evaluation (6 weeks after the surgery)
- Intra-oral photography
- Width of keratinized tissues with the use of periodontal probe (Hu-Friedy XP-23/QW)
- Thickness of mucosa determined by the ultrasonic device SDM in the aforementioned standardized points with the use of the reference stent.
- Radiographic examination (The long-cone paralleling technique will be used at a distance of 10 cm between the X-ray head and the digital sensor which is attached to a custom-made silicone bite block for reproducible radiographs.)
Sixth visit - T4 - Final evaluation (3 months after the extraction)
- Intra-oral photography
- Record of periodontal plaque index (Pl) and bleeding on probing (BoP) at the adjacent teeth with the use of periodontal probe (Hu-Friedy XP-23/QW).
- Record of the width of keratinized tissues with the use of periodontal probe (Hu-Friedy XP-23/QW) and the thickness with the use of the ultrasonic device SDM in the aforementioned standardized points with the use of the reference stent.
- Radiographic examination with standardized intraoral x-ray and CBCT (with the use of the reference stent)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised controlled clinical trial having 3 parallel intervention arms for alveolar ridge preservation and prevention of future alveolar bone resorption due to volumetric changes of tissues post-tooth extraction.
| Arm | Type | Receives |
|---|---|---|
| Spontaneous healing | Other | Other: Routine treatment of the extraction socketRoutine treatment of the extraction socket. Extraction of the tooth and suturing of the extraction socket with resorbable suture PGA 5/0 (polygalactic acid 5/0 sutures; PGA, medipac, Greece). |
| Free gingival graft | Active comparator | Procedure: Socket seal technique by a free gingival graftExtraction of the tooth, placement of a Free Gingival Graft taken from the palate and adjusted to seal the socket opening and stabilize it by resorbable sutures PGA 5/0 (polygalactic acid 5/0 sutures; PGA, medipac, Greece). |
| Polylactic-Glycolic Acid membrane | Experimental | Procedure: Socket seal technique using a synthetic resorbable membraneExtraction of the tooth, adjustment of the Polylactic-Glycolic Acid membrane (PLGA,Tisseos®, Biomedical Tissues, Septodont, France) over the socket opening resting by 1 mm over the alveolar crest of the extraction socket. Tissues are sutured over the barrier by resorbable sutures PGA 5/0 (polygalactic acid 5/0 sutures; PGA, medipac, Greece). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Referrals for a single tooth extraction
- Periodontal destruction less than 50% of tooth support
- Signed inform consent form
Key exclusion criteria (6 listed)
- Systematic diseases, contradicting surgical procedures and compromise wound healing (i.e. uncontrolled diabetes)
- Medication that interferes with bone metabolism
- Pregnancy or lactation
- Multiple extractions
- Absence of adjacent teeth
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 |
|---|---|---|
| Routine treatment of the extraction socketSuturing of the extraction socket with resorbable suture PGA 5/0 in order to protect the blood clot | Other | Spontaneous healing |
| Socket seal technique by a free gingival graftPlacement of a free gingival graft in the socket opening in order to protect and stabilize the blood clot followed by suturing | Procedure or surgery | Free gingival graft |
| Socket seal technique using a synthetic resorbable membranePlacement of a synthetic barrier in the socket opening in order to protect and stabilize the blood clot followed by suturing | Procedure or surgery | Polylactic-Glycolic Acid membrane |
Primary outcome
Osseous changes in height of the alveolar ridge
Time frame: Clinically: immediately after tooth extraction(baseline), 6 weeks and 3 months after the extraction. CBCT: immediately after the extraction and 3 months after the extraction
The height of the alveolar ridge will be measured at standardized points distal, mesial and buccal/ palatal/ lingual at standardized points with the use of a reference stent by a CBCT.
Osseous changes in width of the alveolar ridge
Time frame: Immediately after the extraction(baseline) and 3 months after the extraction
The width of the alveolar ridge will be measured distal, mesial and buccal/ palatal/ lingual at standardized points with the use of a reference stent by a CBCT.
3 secondary outcomes
Mucosa thickness changes
Time frame: Baseline, 6 weeks and 3 months after the extraction
Width of keratinized tissues
Time frame: Baseline, 6 weeks and 3 months after the extraction
Wound healing
Time frame: 1 and 2 weeks after the extraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Background: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Background: PubMed 23346895Farmer M, Darby I. Ridge dimensional changes following single-tooth extraction in the aesthetic zone. Clin Oral Implants Res. 2014 Feb;25(2):272-7. doi: 10.1111/clr.12108. Epub 2013 Jan 25.
- Background: PubMed 28861284Maiorana C, Poli PP, Deflorian M, Testori T, Mandelli F, Nagursky H, Vinci R. Alveolar socket preservation with demineralised bovine bone mineral and a collagen matrix. J Periodontal Implant Sci. 2017 Aug;47(4):194-210. doi: 10.5051/jpis.2017.47.4.194. Epub 2017 Aug 11.
- Background: PubMed 15506024Prato GP, Cairo F, Tinti C, Cortellini P, Muzzi L, Mancini EA. Prevention of alveolar ridge deformities and reconstruction of lost anatomy: a review of surgical approaches. Int J Periodontics Restorative Dent. 2004 Oct;24(5):434-45. doi: 10.11607/prd.00.0602.
- Background: PubMed 15626317Jung RE, Siegenthaler DW, Hammerle CH. Postextraction tissue management: a soft tissue punch technique. Int J Periodontics Restorative Dent. 2004 Dec;24(6):545-53.
- Background: PubMed 29928175Annunziata M, Guida L, Nastri L, Piccirillo A, Sommese L, Napoli C. The Role of Autologous Platelet Concentrates in Alveolar Socket Preservation: A Systematic Review. Transfus Med Hemother. 2018 May;45(3):195-203. doi: 10.1159/000488061. Epub 2018 May 3.
- Individual participant dataSharing planned: No. Overall data but not on an individual basis will be disclosed and shared
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine treatment of the extraction socket, Socket seal technique by a free gingival graft and Socket seal technique using a synthetic resorbable membrane in people with Alveolar Bone Resorption, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Oct 2024. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danae Apatzidou, Assoc. Professor (+306934770361, dapatzidou@dent.auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osseous changes in height of the alveolar ridge (time frame: Clinically: immediately after tooth extraction(baseline), 6 weeks and 3 months after the extraction. CBCT: immediately after the extraction and 3 months after the extraction). The study lists 2 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 NCT05577663, which also lists 6 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 17 Oct 2024.