Midfacial Mucosal RecessionNCT07899320
Association Between Peri-implant Soft Tissue Thickness and Midfacial Marginal Mucosal Recession
An observational study of Midfacial Mucosal Recession, run by International Dental Contiuing Education.
Trial summary
Peri-implant mucosal recession in the anterior esthetic zone is a clinically important complication because it can expose implant components, compromise esthetics, and reduce patient satisfaction. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Midfacial Mucosal Recession
- What is being tested?
- immediate implant placement
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 May 2027
- Phase
- Observational
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: adults who received a single implant-supported crown in the maxillary esthetic zone, preferably central incisors, lateral incisors, and canines.
Who may be able to join
- Age 18 years or older.
- Single implant in the maxillary anterior region.
- Adequate plaque control and periodontal stability.
- Healthy peri-implant tissues at the baseline assessment.
- Ability to attend scheduled follow-up visits.
- Signed informed consent.
Who cannot join
- Uncontrolled periodontal disease or active peri-implant disease.
- Uncontrolled systemic conditions likely to compromise healing.
- Heavy smoking, or record smoking and include it as a covariate if exclusion is impractical.
- Sites with pre-existing severe facial mucosal recession that would make the primary outcome difficult to interpret.
- Major facial bone defects or implant malposition that cannot be adequately characterized.
- Concurrent procedures that substantially alter the soft-tissue anatomy, unless these are explicitly included in the study protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Peri-implant Soft Tissue Thickness and Midfacal Mucosal Recession Around Implants in the Esthetic Zone: A Retrospective Study.
Peri-implant mucosal recession in the anterior esthetic zone is a clinically important complication because it can expose implant components, compromise esthetics, and reduce patient satisfaction. Soft-tissue thickness is considered one of the factors that may influence marginal mucosal stability, but the thickness required to minimize recession remains uncertain and may depend on implant position, facial bone thickness, tissue phenotype, surgical technique, and the timing of implant placement.
The central research question is: Is there a minimum peri-implant soft-tissue thickness at implant placement or restoration that is associated with a clinically meaningful reduction in midfacial mucosal recession over time?
An important distinction for the study is that an association between thicker tissue and less recession does not, by itself, establish a universal protective thickness threshold. The study should investigate both the continuous relationship between tissue thickness and recession and whether a clinically useful cutoff can be identified.
Read the detailed description
Long-term stability of the peri-implant soft tissues is an important determinant of the esthetic success of implant-supported restorations, particularly in the maxillary anterior region. Mid-facial peri-implant mucosal recession may compromise esthetic outcomes by causing apical migration of the mucosal margin, exposure of implant or prosthetic components, and asymmetry with the adjacent natural dentition.
Several anatomical, surgical, and prosthetic factors may influence peri-implant mucosal stability, including facial bone thickness, implant positioning, peri-implant tissue phenotype, implant placement timing, and prosthetic emergence profile. Facial peri-implant soft-tissue thickness has been suggested as a potentially important factor affecting the stability of the mucosal margin. However, the minimum soft-tissue thickness required to maintain long-term mid-facial mucosal stability and minimize the risk of recession remains uncertain.
The present study is designed to retrospectively evaluate the relationship between facial peri-implant soft-tissue thickness at the time of definitive crown delivery and subsequent changes in the mid-facial mucosal marginal level over a follow-up period ranging from 2 to 5 years.
This study will follow a retrospective observational longitudinal cohort design. Adult patients who received single implant-supported crowns in the maxillary esthetic zone at least 2 years and up to 5 years prior to the study assessment will be identified through existing clinical records and screened according to predefined eligibility criteria. All implant surgical and prosthetic procedures will have been performed as part of routine clinical care, according to standard clinical protocols and individual treatment requirements. No experimental surgical or prosthetic interventions will be assigned as part of the study.
Facial peri-implant soft-tissue thickness recorded at the time of definitive crown delivery will be retrieved from existing clinical records. Measurements will be included only when they were obtained using a documented and sufficiently standardized clinical measurement technique at a reproducible location on the mid-facial aspect of the implant-supported restoration. Soft-tissue thickness will be expressed in millimeters and analyzed as a continuous variable.
Similarly, the mid-facial mucosal marginal level recorded at definitive crown delivery will be retrieved from available clinical records, photographs, or digital scans, provided that a reliable and reproducible reference point associated with the definitive implant-supported restoration can be identified. This measurement will serve as the baseline for evaluating subsequent marginal tissue changes.
Follow-up measurements of the mid-facial mucosal marginal level will be obtained from existing clinical documentation recorded between 2 and 5 years after definitive crown delivery. Where necessary and permitted by the study protocol, eligible patients may be recalled for a current clinical examination to obtain an updated mid-facial mucosal marginal level measurement.
Changes in the mid-facial mucosal marginal level will be calculated by comparing the baseline measurement at definitive crown delivery with the available follow-up measurements. The relationship between baseline facial peri-implant soft-tissue thickness and subsequent marginal tissue changes will then be evaluated to investigate whether greater soft-tissue thickness is associated with improved long-term mucosal stability and a reduced risk of mid-facial peri-implant mucosal recession.
- Conditions
- Midfacial Mucosal Recession
- Being tested
- immediate implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placementProcedure or surgery
Flapless immediate implant placement in anterior maxilla
| Study group | Role | What they receive |
|---|---|---|
| IIP in anterior Maxilla | Not described Receives: Procedure: immediate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midfacial Mucosal Recession
Change in midfacial mucosal level from definitive restoration expressed in millimeters.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Midfacial Mucosal RecessionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Dental Contiuing Education
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Nourhan Gamal, International Dental Contiuing Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899320
- Sponsor's protocol ID
- IDCE-1102026
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tavelli L, Sabri H, Barootchi E, Stefanini M, Zucchelli G, Wang HL, Urban IA, Barootchi S. Protective factors and critical mucosal thickness for the stability of the peri-implant soft tissue margin over 5 years: A longitudinal cohort study. J Periodontol. 2026 Jul 12. doi: 10.1002/jper.70159. Online ahead of print.
PubMed 42438281Zucchelli G, Tavelli L, Stefanini M, Barootchi S, Mazzotti C, Gori G, Wang HL. Classification of facial peri-implant soft tissue dehiscence/deficiencies at single implant sites in the esthetic zone. J Periodontol. 2019 Oct;90(10):1116-1124. doi: 10.1002/JPER.18-0616. Epub 2019 Jun 3.
PubMed 31087334
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Peri-implant Soft Tissue Thickness and Midfacal Mucosal Recession Around Implants in the Esthetic Zone: A Retrospective Study.
- ClinicalTrials.gov ID
- NCT07899320
- Acronym / sponsor ID
- IDCE-1102026
- Conditions
- Midfacial Mucosal Recession
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- International Dental Contiuing EducationResearch network
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
Peri-implant mucosal recession in the anterior esthetic zone is a clinically important complication because it can expose implant components, compromise esthetics, and reduce patient satisfaction. Soft-tissue thickness is considered one of the factors that may influence marginal mucosal stability, but the thickness required to minimize recession remains uncertain and may depend on implant position, facial bone thickness, tissue phenotype, surgical technique, and the timing of implant placement.
The central research question is: Is there a minimum peri-implant soft-tissue thickness at implant placement or restoration that is associated with a clinically meaningful reduction in midfacial mucosal recession over time?
An important distinction for the study is that an association between thicker tissue and less recession does not, by itself, establish a universal protective thickness threshold. The study should investigate both the continuous relationship between tissue thickness and recession and whether a clinically useful cutoff can be identified.
Detailed description
Long-term stability of the peri-implant soft tissues is an important determinant of the esthetic success of implant-supported restorations, particularly in the maxillary anterior region. Mid-facial peri-implant mucosal recession may compromise esthetic outcomes by causing apical migration of the mucosal margin, exposure of implant or prosthetic components, and asymmetry with the adjacent natural dentition.
Several anatomical, surgical, and prosthetic factors may influence peri-implant mucosal stability, including facial bone thickness, implant positioning, peri-implant tissue phenotype, implant placement timing, and prosthetic emergence profile. Facial peri-implant soft-tissue thickness has been suggested as a potentially important factor affecting the stability of the mucosal margin. However, the minimum soft-tissue thickness required to maintain long-term mid-facial mucosal stability and minimize the risk of recession remains uncertain.
The present study is designed to retrospectively evaluate the relationship between facial peri-implant soft-tissue thickness at the time of definitive crown delivery and subsequent changes in the mid-facial mucosal marginal level over a follow-up period ranging from 2 to 5 years.
This study will follow a retrospective observational longitudinal cohort design. Adult patients who received single implant-supported crowns in the maxillary esthetic zone at least 2 years and up to 5 years prior to the study assessment will be identified through existing clinical records and screened according to predefined eligibility criteria. All implant surgical and prosthetic procedures will have been performed as part of routine clinical care, according to standard clinical protocols and individual treatment requirements. No experimental surgical or prosthetic interventions will be assigned as part of the study.
Facial peri-implant soft-tissue thickness recorded at the time of definitive crown delivery will be retrieved from existing clinical records. Measurements will be included only when they were obtained using a documented and sufficiently standardized clinical measurement technique at a reproducible location on the mid-facial aspect of the implant-supported restoration. Soft-tissue thickness will be expressed in millimeters and analyzed as a continuous variable.
Similarly, the mid-facial mucosal marginal level recorded at definitive crown delivery will be retrieved from available clinical records, photographs, or digital scans, provided that a reliable and reproducible reference point associated with the definitive implant-supported restoration can be identified. This measurement will serve as the baseline for evaluating subsequent marginal tissue changes.
Follow-up measurements of the mid-facial mucosal marginal level will be obtained from existing clinical documentation recorded between 2 and 5 years after definitive crown delivery. Where necessary and permitted by the study protocol, eligible patients may be recalled for a current clinical examination to obtain an updated mid-facial mucosal marginal level measurement.
Changes in the mid-facial mucosal marginal level will be calculated by comparing the baseline measurement at definitive crown delivery with the available follow-up measurements. The relationship between baseline facial peri-implant soft-tissue thickness and subsequent marginal tissue changes will then be evaluated to investigate whether greater soft-tissue thickness is associated with improved long-term mucosal stability and a reduced risk of mid-facial peri-implant mucosal recession.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IIP in anterior Maxilla | – | Procedure: immediate implant placement |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- adults who received a single implant-supported crown in the maxillary esthetic zone, preferably central incisors, lateral incisors, and canines.
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Single implant in the maxillary anterior region.
- Adequate plaque control and periodontal stability.
- Healthy peri-implant tissues at the baseline assessment.
- Ability to attend scheduled follow-up visits.
Key exclusion criteria (6 listed)
- Uncontrolled periodontal disease or active peri-implant disease.
- Uncontrolled systemic conditions likely to compromise healing.
- Heavy smoking, or record smoking and include it as a covariate if exclusion is impractical.
- Sites with pre-existing severe facial mucosal recession that would make the primary outcome difficult to interpret.
- Major facial bone defects or implant malposition that cannot be adequately characterized.
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 implant placementFlapless immediate implant placement in anterior maxilla | Procedure or surgery | IIP in anterior Maxilla |
Primary outcome
Midfacial Mucosal Recession
Time frame: 5 years
Change in midfacial mucosal level from definitive restoration expressed in millimeters.
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 27 Oct 2026.
- Background: PubMed 42438281Tavelli L, Sabri H, Barootchi E, Stefanini M, Zucchelli G, Wang HL, Urban IA, Barootchi S. Protective factors and critical mucosal thickness for the stability of the peri-implant soft tissue margin over 5 years: A longitudinal cohort study. J Periodontol. 2026 Jul 12. doi: 10.1002/jper.70159. Online ahead of print.
- Background: PubMed 31087334Zucchelli G, Tavelli L, Stefanini M, Barootchi S, Mazzotti C, Gori G, Wang HL. Classification of facial peri-implant soft tissue dehiscence/deficiencies at single implant sites in the esthetic zone. J Periodontol. 2019 Oct;90(10):1116-1124. doi: 10.1002/JPER.18-0616. Epub 2019 Jun 3.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Midfacial Mucosal Recession, run by International Dental Contiuing Education.
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 6 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Nourhan Gamal, MSc (Egypt, Nourhannegamal259@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Midfacial Mucosal Recession (time frame: 5 years). 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 NCT07899320, which also lists 2 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 27 Oct 2026.