Dental Implant FailedNCT05060055
Digital Assessment at Peri-implant Tissues After Immediate Implants With Customized Healing Abutments and Connective Tissue Grafts
A study testing Immediate dental implant placement in people with Dental Implant Failed, run by Universidade Católica Portuguesa at 1 site in Portugal.
Trial summary
After a single-tooth extraction, physiological remodeling processes are unavoidable which leads to a total loss of the periodontal ligament and resorption of the bundle bone. Immediate implant placement associated with bone substitutes and customized healing abutments seems to reduce the amount of resorption at… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- Immediate dental implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2021to 9 Nov 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) ≥18 years of age; 2) patients who had a failing tooth and needed an implant placing therapy in the aesthetic zone (between 15-25); 3) the failing tooth has adjacent and opposing natural teeth; 4) sufficient mesial-distal and inter-occlusal space for placement of the implant and definitive restoration; 5) had an intact socket wall previously to the extraction; 6) had sufficient apical bone to place an immediate implant with minimum primary stability of 30 N/cm.
Who cannot join
- individuals diagnosed with periodontal disease; medical and general contraindications for the surgical procedure; heavy smokers (> 10 cigarettes/day); an active infection at the implant site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Volumetric Digital Analysis on the Effect of a Customized Healing Abutment With or Without Connective Tissue Graft at Maxillary Immediate Implant Sites - A Randomized Clinical Trial
After a single-tooth extraction, physiological remodeling processes are unavoidable which leads to a total loss of the periodontal ligament and resorption of the bundle bone. Immediate implant placement associated with bone substitutes and customized healing abutments seems to reduce the amount of resorption at peri-implant areas. Recently, studies evaluating the use of a connective tissue grafts are being conducted in order to assess possible final outcome advantages in immediate implant procedures. This study aims to evaluate peri-implant tissue dimensional changes after the use of a customized healing abutment with or without connective tissue graft in flapless maxillary immediate implant placement.
Read the detailed description
The present study was designed as a prospective, controlled clinical trial with a parallel-group design and balanced randomization (ratio 1:1) to document the peri-implant tissues response in using a customized healing abutment with a connective tissue graft (Test group) or without a connective tissue graft (Control group) xenogeneic collagen matrix (Group CM) or a customized healing abutment (Group CA) in flapless maxillary immediate implants. The protocol was reviewed and approved by the Institute of Bioethics of the Catholic University of Portugal (Project nº 139) and the patients included will be previously informed to participate in this investigation signing an informed consent considering the 1975 Declaration of Helsinki, revised in 2013. Group designation will be kept in opaque-sealed envelopes that will be opened after implant insertion by an investigator (D.F), not involved in surgical procedures, randomly allocating participants to one of the two treatment groups. Patients' inclusion criteria are: 1) ≥18 years of age; 2) patients who had a failing tooth and needed an implant placing therapy in the aesthetic zone (between 15-25); 3) the failing tooth has adjacent and opposing natural teeth; 4) sufficient mesial-distal and inter-occlusal space for placement of the implant and definitive restoration; 5) had an intact socket wall previously to the extraction; 6) had sufficient apical bone to place an immediate implant with minimum primary stability of 30 N/cm. Exclusion criteria are: individuals diagnosed with periodontal disease; medical and general contraindications for the surgical procedure; heavy smokers (> 10 cigarettes/day); an active infection at the implant site. A CONSORT 2010 check-list will be also performed in order to consider an appropriate guideline for the present randomized trial study.
All surgical procedures will be conducted under appropriate local anesthesia 4% articaine with adrenaline 1:100000 (UbistesinTM, 3M-ESPE, St. Paul, MN, USA). In both groups, flapless tooth extractions will be performed after sectioning the tooth, followed by the use of periotomes and elevators to separate the two parts of the tooth, avoiding damage to the buccal and palatal bone plates. All patients will be treated with cylindrical shape implants (OsseoSpeed EV™, AstraTech Implant System, Dentsply Implants, Möhndal, Sweden) with a narrow diameter internal connection platform following the surgical sequence protocol provided by the manufacturer. Both groups will receive a customized healing abutment made of polymethyl methacrylate (PMMA) material, designed and fabricated accordingly with the gingival contour of the original tooth. Patients included in the Test group will receive connective tissue grafts harvested using the single incision technique.
A protocol was elaborated to study the variables of interest. One examiner, blinded for the surgical procedure, will be calibrated through an intra-examiner test (Dahlberg d-value), consisting in a double consecutive data collection of 10 randomly chosen patients included in this study.
Data collection will be performed in four appointments. A Cone Beam Computer Tomography (CBCT) evaluation (Ortophos XG 3D®, Sirona Dental Systems GmbH, Bensheim, Germany) will be performed before tooth extraction and implant placement (T0). At this point, two clinical parameters will be assessed with a periodontal probe (PCB 12; Hu-Friedy, Chicago, IL, USA) to the nearest millimeter: BID (distance between implant shoulder and the buccal bone plate) and KM (distance between the gingival groove and the mucogingival junction). Digital impressions (Cerec Omnicam®, Sirona Dental Systems GmbH, Bensheim, Germany) will be taken prior to extraction (T0), one month (T1), four months (T2) and 12 months (T3) after implant insertion allowing to superimpose the digital files and to evaluate volumetric changes between different time points at peri-implant tissue areas like Buccal Volume Variation (BVv) and Total Volume Variation (TVv). Mucosa variation between T0 and T3 will be digitally computed assessing the papilla presence at mesial (MPHv) and distal (DPHv) sites and the mucosa height (MGHv). Mean values will be compared and statistical significance will be at 0,05.
- Conditions
- Dental Implant Failed
- Being tested
- Immediate dental implant placement
- Keywords
- autografts, wound healing, three-dimensional imaging, treatment outcome, dental implants, alveolar ridge augmentation, alveolar bone loss
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate dental implant placementProcedure or surgery
Immediate dental implant placement
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Customized healing abutment inserted in immediate implant placement in association with the use of a connective tissue graft. Receives: Procedure: Immediate dental implant placement |
| Control Group | Active comparator | Customized healing abutment inserted in immediate implant placement. Receives: Procedure: Immediate dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal volume variation (BVvT0)
Variation of the alveolar volume at the buccal aspect. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Buccal Volume Variation (BVv0-1, BVv0-2, and BVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0.
Measured: Baseline (T0); 1 month (T1); 4 months (T2) and 12 months (T3)
Buccal volume variation (BVvT1)
Variation of the alveolar volume at the buccal aspect. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Buccal Volume Variation (BVv0-1, BVv0-2, and BVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0.
Measured: 1 month (T1)
Buccal volume variation (BVvT2)
Variation of the alveolar volume at the buccal aspect. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Buccal Volume Variation (BVv0-1, BVv0-2, and BVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0.
Measured: 4 months (T2)
Buccal volume variation (BVvT3)
Variation of the alveolar volume at the buccal aspect. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Buccal Volume Variation (BVv0-1, BVv0-2, and BVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0.
Measured: 12 months (T3)
Total volume variation (TVvT0)
Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0
Measured: Baseline (T0); 1 month (T1); 4 months (T2) and 12 months (T3)
Total volume variation (TVvT0)
Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0
Measured: Baseline (T0)
Total volume variation (TVvT1)
Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0
Measured: 1 month (T1)
Total volume variation (TVvT2)
Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0
Measured: 4 months (T2)
Total volume variation (TVvT3)
Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0
Measured: 12 months (T3)
Secondary outcomes (1)
Buccal wall thickness (BT)
measurement of the facial bone wall. The acquisition of radiographic images was performed with a volumetric dimension of 8 x 8 cm for 14s with the XG 3D tomography acquisition protocol, with a voxel size of 0.1 mm in HD mode. BT was measured 1 mm above the coronal bone margin using a central slice, as well at the mesial and distal slices, ranging 1 mm from the central slice. Mean BT values were obtained as the average values of the three slices. Measurements were made in mm.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Oct 2021
- Primary completion4 Nov 2022
- Study completion9 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Implant FailedStudies 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
- The present study was designed as a prospective, controlled clinical trial with a parallel-group design and balanced randomization (ratio 1:1)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Católica Portuguesa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiago Borges, Universidade Católica Portuguesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060055
- Sponsor's protocol ID
- UCatolicaPortuguesa
- Status last verified
- Nov 2022
- First submitted
- 26 Jul 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fernandes D, Marques T, Borges T, Montero J. Volumetric analysis on the use of customized healing abutments with or without connective tissue graft at flapless maxillary immediate implant placement: A randomized clinical trial. Clin Oral Implants Res. 2023 Sep;34(9):934-946. doi: 10.1111/clr.14119. Epub 2023 Jun 29.
PubMed 37386752
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Digital Analysis on the Effect of a Customized Healing Abutment With or Without Connective Tissue Graft at Maxillary Immediate Implant Sites - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05060055
- Acronym / sponsor ID
- UCatolicaPortuguesa
- Conditions
- Dental Implant Failed
- Keywords
- autografts, wound healing, three-dimensional imaging, treatment outcome, dental implants, alveolar ridge augmentation, alveolar bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade Católica PortuguesaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 28 Sep 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.
After a single-tooth extraction, physiological remodeling processes are unavoidable which leads to a total loss of the periodontal ligament and resorption of the bundle bone. Immediate implant placement associated with bone substitutes and customized healing abutments seems to reduce the amount of resorption at peri-implant areas. Recently, studies evaluating the use of a connective tissue grafts are being conducted in order to assess possible final outcome advantages in immediate implant procedures. This study aims to evaluate peri-implant tissue dimensional changes after the use of a customized healing abutment with or without connective tissue graft in flapless maxillary immediate implant placement.
Detailed description
The present study was designed as a prospective, controlled clinical trial with a parallel-group design and balanced randomization (ratio 1:1) to document the peri-implant tissues response in using a customized healing abutment with a connective tissue graft (Test group) or without a connective tissue graft (Control group) xenogeneic collagen matrix (Group CM) or a customized healing abutment (Group CA) in flapless maxillary immediate implants. The protocol was reviewed and approved by the Institute of Bioethics of the Catholic University of Portugal (Project nº 139) and the patients included will be previously informed to participate in this investigation signing an informed consent considering the 1975 Declaration of Helsinki, revised in 2013. Group designation will be kept in opaque-sealed envelopes that will be opened after implant insertion by an investigator (D.F), not involved in surgical procedures, randomly allocating participants to one of the two treatment groups. Patients' inclusion criteria are: 1) ≥18 years of age; 2) patients who had a failing tooth and needed an implant placing therapy in the aesthetic zone (between 15-25); 3) the failing tooth has adjacent and opposing natural teeth; 4) sufficient mesial-distal and inter-occlusal space for placement of the implant and definitive restoration; 5) had an intact socket wall previously to the extraction; 6) had sufficient apical bone to place an immediate implant with minimum primary stability of 30 N/cm. Exclusion criteria are: individuals diagnosed with periodontal disease; medical and general contraindications for the surgical procedure; heavy smokers (> 10 cigarettes/day); an active infection at the implant site. A CONSORT 2010 check-list will be also performed in order to consider an appropriate guideline for the present randomized trial study.
All surgical procedures will be conducted under appropriate local anesthesia 4% articaine with adrenaline 1:100000 (UbistesinTM, 3M-ESPE, St. Paul, MN, USA). In both groups, flapless tooth extractions will be performed after sectioning the tooth, followed by the use of periotomes and elevators to separate the two parts of the tooth, avoiding damage to the buccal and palatal bone plates. All patients will be treated with cylindrical shape implants (OsseoSpeed EV™, AstraTech Implant System, Dentsply Implants, Möhndal, Sweden) with a narrow diameter internal connection platform following the surgical sequence protocol provided by the manufacturer. Both groups will receive a customized healing abutment made of polymethyl methacrylate (PMMA) material, designed and fabricated accordingly with the gingival contour of the original tooth. Patients included in the Test group will receive connective tissue grafts harvested using the single incision technique.
A protocol was elaborated to study the variables of interest. One examiner, blinded for the surgical procedure, will be calibrated through an intra-examiner test (Dahlberg d-value), consisting in a double consecutive data collection of 10 randomly chosen patients included in this study.
Data collection will be performed in four appointments. A Cone Beam Computer Tomography (CBCT) evaluation (Ortophos XG 3D®, Sirona Dental Systems GmbH, Bensheim, Germany) will be performed before tooth extraction and implant placement (T0). At this point, two clinical parameters will be assessed with a periodontal probe (PCB 12; Hu-Friedy, Chicago, IL, USA) to the nearest millimeter: BID (distance between implant shoulder and the buccal bone plate) and KM (distance between the gingival groove and the mucogingival junction). Digital impressions (Cerec Omnicam®, Sirona Dental Systems GmbH, Bensheim, Germany) will be taken prior to extraction (T0), one month (T1), four months (T2) and 12 months (T3) after implant insertion allowing to superimpose the digital files and to evaluate volumetric changes between different time points at peri-implant tissue areas like Buccal Volume Variation (BVv) and Total Volume Variation (TVv). Mucosa variation between T0 and T3 will be digitally computed assessing the papilla presence at mesial (MPHv) and distal (DPHv) sites and the mucosa height (MGHv). Mean values will be compared and statistical significance will be at 0,05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The present study was designed as a prospective, controlled clinical trial with a parallel-group design and balanced randomization (ratio 1:1)
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Procedure: Immediate dental implant placementCustomized healing abutment inserted in immediate implant placement in association with the use of a connective tissue graft. |
| Control Group | Active comparator | Procedure: Immediate dental implant placementCustomized healing abutment inserted in immediate implant placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) ≥18 years of age; 2) patients who had a failing tooth and needed an implant placing therapy in the aesthetic zone (between 15-25); 3) the failing tooth has adjacent and opposing natural teeth; 4) sufficient mesial-distal and inter-occlusal space for placement of the implant and definitive restoration; 5) had an intact socket wall previously to the extraction; 6) had sufficient apical bone to place an immediate implant with minimum primary stability of 30 N/cm.
Key exclusion criteria (1 listed)
- individuals diagnosed with periodontal disease; medical and general contraindications for the surgical procedure; heavy smokers (> 10 cigarettes/day); an active infection at the implant site.
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 |
|---|---|---|
| Immediate dental implant placementImmediate dental implant placement | Procedure or surgery | Control Group, Test Group |
Primary outcome
Buccal volume variation (BVvT0)
Time frame: Baseline (T0); 1 month (T1); 4 months (T2) and 12 months (T3)
Variation of the alveolar volume at the buccal aspect. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Buccal Volume Variation (BVv0-1, BVv0-2, and BVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0.
Buccal volume variation (BVvT1)
Time frame: 1 month (T1)
Variation of the alveolar volume at the buccal aspect. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Buccal Volume Variation (BVv0-1, BVv0-2, and BVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0.
Buccal volume variation (BVvT2)
Time frame: 4 months (T2)
Variation of the alveolar volume at the buccal aspect. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Buccal Volume Variation (BVv0-1, BVv0-2, and BVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0.
Buccal volume variation (BVvT3)
Time frame: 12 months (T3)
Variation of the alveolar volume at the buccal aspect. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Buccal Volume Variation (BVv0-1, BVv0-2, and BVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0.
Total volume variation (TVvT0)
Time frame: Baseline (T0); 1 month (T1); 4 months (T2) and 12 months (T3)
Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0
Total volume variation (TVvT0)
Time frame: Baseline (T0)
Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0
Total volume variation (TVvT1)
Time frame: 1 month (T1)
Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0
Total volume variation (TVvT2)
Time frame: 4 months (T2)
Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0
Total volume variation (TVvT3)
Time frame: 12 months (T3)
Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0
1 secondary outcome
Buccal wall thickness (BT)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 37386752Fernandes D, Marques T, Borges T, Montero J. Volumetric analysis on the use of customized healing abutments with or without connective tissue graft at flapless maxillary immediate implant placement: A randomized clinical trial. Clin Oral Implants Res. 2023 Sep;34(9):934-946. doi: 10.1111/clr.14119. Epub 2023 Jun 29.
Related trials for Dental Implant Failed
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
Recruiting
Clinical Performance of Dual-cantilevered Single-implant Bridge
Dental Implant Failed
Active, not recruiting
Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation
Alveolar Bone Loss, Dental Implant Failed
Enrolling by invitationObservational study
Short Implants Produced by Additive Manufacturing in the Posterior Jaws: 3 Years of Follow-up
Periodontal Diseases, Dental Implant Failed
Recruiting
Effect of Systemic Vitamin D on Dental Implant Osseointegration
Dental Implant, Dental Implant Failed
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate dental implant placement in people with Dental Implant Failed, run by Universidade Católica Portuguesa at 1 site in Portugal.
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 1 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: finished, as of the sponsor's last update on 15 Nov 2022. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Buccal volume variation (BVvT0) (time frame: Baseline (T0); 1 month (T1); 4 months (T2) and 12 months (T3)). The study lists 9 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 NCT05060055, which also lists 1 linked publication.
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 15 Nov 2022.