Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation | NCT07772414 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 19, 2026

Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation

Multicenter Randomized Clinical Trial Comparing Apical Flap Repositioning Versus Vestibular Mucosa Excision Associated With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07772414
Lead Sponsor: University of BarcelonaOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 46Estimated
Last Update Posted: Aug 19, 2026Actual
Start Date: Sep 30, 2026Estimated
Primary Completion Date: Sep 30, 2028Estimated
Completion Date: Mar 30, 2029Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Multicenter Randomized Clinical Trial Comparing Apical Flap Repositioning Versus Vestibular Mucosa Excision Associated With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation
Brief Summary: The goal of this clinical trial is to learn which surgical technique works better to increase the amount of firm gum tissue (called keratinized mucosa) around dental implants in adults.

The main question it aims to answer is:

-Does repositioning the gum flap upward with stitches lead to a greater gain in firm gum tissue width at 6 months compared to simply removing the extra gum tissue, when both techniques are combined with a free gum graft?

Researchers will compare two techniques used during the second stage of implant surgery to see which one produces a greater gain in firm gum tissue around the implant.

Participants will:

Receive a free gum graft (a small piece of tissue taken from the roof of the mouth) placed around their dental implant during a routine surgical visit

Be randomly assigned to one of the two surgical techniques

Have digital scans of their mouth taken at 5 timepoints over 6 months

Complete a pain diary and answer questions about their experience during the first week after surgery

Attend follow-up visits at 6 weeks, 3 months, and 6 months after surgery

Conditions

The medical conditions and diseases this study investigates.

Keratinized Mucosa Deficiency
Peri-implant Soft Tissue
Dental Implants

Interventions

The treatments and procedures being evaluated in this study.

Free gingival graft with apical flap repositioning
Free gingival graft with vestibular mucosa excision

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Men or women aged 18 years or older who voluntarily agree to sign the informed consent form before any study-related procedure is performed.

Single or multiple edentulous spaces (≤3 units) located in the posterior maxilla or mandible, presenting osseointegrated implants in first-stage surgery with a -healing period of more than 8 weeks.

ASA classification I or II.

Periodontal and peri-implant health.

O'Leary plaque index ≤15%.

Keratinized mucosa width ≤2 mm and/or vestibular depth <4 mm at at least one site.

Commitment to attend all follow-up visits over 6 months.

Exclusion Criteria:

Systemic diseases that may interfere with performing FGG (free gingival graft), including but not limited to: poorly controlled diabetes mellitus (HbA1c > 8% or per clinical judgment), immunodeficiencies or immunosuppressive treatment, uncontrolled hematological diseases or coagulation disorders, anticoagulant or antiplatelet treatment that cannot be adjusted according to standard clinical practice, active neoplasms under treatment, severe renal or hepatic insufficiency, decompensated cardiovascular diseases, and any other medical condition that, in the investigator's judgment, could compromise participant safety or proper tissue healing.

Any contraindication to oral surgical procedures.

Periodontal and peri-implant health as defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.

Patients who smoke tobacco or equivalent products, as well as former smokers with an abstinence period ≤12 months.

History of substance abuse (drugs or alcohol) or any other factor (e.g., severe psychiatric illness) that, in the investigator's opinion, could interfere with the patient's ability to cooperate and comply with the study.

Patients who have participated in a clinical trial within the last 30 days.

Pregnant or breastfeeding women.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts

The people to reach with questions about this study or how to join it.

Octavi Camps-Font, DDS MS PhDContact

ocamps@ub.edu+34 934 024 269

Locations

Where the study is run and whether each site is currently recruiting.

Hospital Odontològic Universitat de Barcelona, L'Hospitalet de Llobregat,

Barcelona, Barcelona 08907, Spain

Collaborators

The organizations and people involved in this study.

Lead Sponsor: University of BarcelonaOTHER
Collaborators

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Other registered studies that closely resemble this one.

Detailed Description

This superiority multicenter randomized clinical trial is coordinated by the Universitat de Barcelona (UB) and includes the Universidad Complutense de Madrid (UCM) as a collaborating center.

Participant selection Adults with osseointegrated implants in the posterior maxilla or mandible presenting keratinized mucosa width of 2 mm or less and/or vestibular depth less than 4 mm will be screened for eligibility. Participants must be in periodontal and peri-implant health and have a plaque index of 15% or less.

Randomization Eligible participants will be randomly assigned (1:1) to one of two treatment groups using an Interactive Web Response System (IWRS) provided by Sealed Envelope Ltd. Randomization will take place intraoperatively, once the partial-thickness mucosal flap has been prepared.

Interventions

Group 1 (Control): Free gingival graft with apical repositioning and suturing of the vestibular mucosal flap to the periosteum Group 2 (Experimental): Free gingival graft with excision of the vestibular mucous tissue

Outcome assessment Soft tissue changes will be assessed at 5 timepoints (T0, Tim, T6w, T3m, T6m) using intraoral scans (TRIOS 3®, 3Shape) analyzed with Geomagic Control X® software through three-dimensional digital superimposition. Clinical measurements will also be performed using a calibrated periodontal probe and a customized thermoplastic stent to standardize the measurement point across visits.

Participants will complete a pain diary during the first 7 postoperative days recording pain intensity (100 mm visual analogue scale), analgesic consumption, and days with limited activity.

Sample size A total of 46 participants (23 per group) are required, accounting for a minimum clinically relevant difference of 1 mm in KTW gain, a standard deviation of 1.3 mm, 80% statistical power, 5% significance level, an intraclass correlation coefficient of 0.30 for multiple implants per patient, and a 15% dropout rate.

Statistical analysis The primary outcome will be analyzed in the intention-to-treat population using a generalized linear mixed model (GLMM), with patient as a random effect, adjusted for baseline KTW and study center.