Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation (FGGIF)
Multicenter Randomized Clinical Trial Comparing Apical Flap Repositioning Versus Vestibular Mucosa Excision Associated With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation
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
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Octavi Camps-Font, DDS MS PhD
- Numéro de téléphone: +34 934 024 269
- E-mail: ocamps@ub.edu
Sauvegarde des contacts de l'étude
- Nom: Prof. Dr.
- E-mail: ocamps@ub.edu
Lieux d'étude
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Barcelona
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Barcelona, Barcelona, Espagne, 08907
- Hospital Odontològic Universitat de Barcelona, L'Hospitalet de Llobregat,
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Contact:
- Octavi Camps Font DDS MS PhD
- Numéro de téléphone: +34 934 024 269
- E-mail: ocamps@ub.edu
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Apical Flap Repositioning
Free gingival graft with apical repositioning and suturing of the vestibular mucosal flap to the periosteum during second-stage implant surgery.
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Autologous free gingival graft harvested from the palate and placed at the recipient site.
The vestibular mucosal flap is repositioned apically and sutured to the periosteum during second-stage implant surgery.
|
|
Expérimental: Vestibular Mucosa Excision
Free gingival graft with excision of the vestibular mucous tissue during second-stage implant surgery.
|
Autologous free gingival graft harvested from the palate and placed at the recipient site.
The vestibular mucous tissue is excised during second-stage implant surgery.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Peri-implant keratinized tissue width (KTW) gain
Délai: Baseline (T0) to 6 months (T6m)
|
Absolute change in KTW, measured digitally as the linear distance between the mucosal margin and the mucogingival junction on the vestibular aspect of the implant, using Geomagic Control X® software on intraoral scan models (TRIOS 3®, 3Shape).
|
Baseline (T0) to 6 months (T6m)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical gain in peri-implant keratinized tissue width (KTW)
Délai: Baseline (T0) to 6 months (T6m)
|
Absolute change in KTW, measured clinically with a calibrated periodontal probe using a customized thermoplastic stent.
|
Baseline (T0) to 6 months (T6m)
|
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Change in graft height
Délai: Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
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Change in graft height, measured in millimeters (mm), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
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Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
|
|
Change in graft width
Délai: Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
|
Change in graft width, measured in millimeters (mm), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
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Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
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Graft area contraction
Délai: Immediate postoperative (Tim) to 6 months (T6m)
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Percentage of graft area reduction between immediate postoperative and 6 months, assessed by 3D digital superimposition.
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Immediate postoperative (Tim) to 6 months (T6m)
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Change in graft volume
Délai: Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
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Change in graft volume, measured in cubic millimeters (mm³), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
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Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
|
|
Vestibular depth
Délai: Baseline (T0) to 6 months (T6m)
|
Change in vestibular depth from baseline to 6 months, assessed both digitally and clinically.
|
Baseline (T0) to 6 months (T6m)
|
|
Surgical time
Délai: Intraoperative (Tim)
|
Time in minutes from anesthesia administration to placement of the last suture.
|
Intraoperative (Tim)
|
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Adverse events
Délai: Immediate postoperative (Tim) to 6 months (T6m)
|
Incidence and nature of postoperative adverse events related to the free gingival graft procedure.
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Immediate postoperative (Tim) to 6 months (T6m)
|
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Clinician-perceived surgical difficulty
Délai: Intraoperative (Tim)
|
Degree of surgical difficulty perceived by the clinician at the end of the procedure, evaluated using a 100 mm visual analogue scale (0 = no difficulty, 100 = maximum imaginable difficulty).
|
Intraoperative (Tim)
|
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Postoperative pain
Délai: Up to 7 days postoperat
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Pain intensity recorded at the end of the procedure and at 2, 6, 12 and 24 hours, and daily for 7 days, using a 100 mm visual analogue scale (0 = no pain, 100 = worst imaginable pain).
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Up to 7 days postoperat
|
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Analgesic consumption
Délai: Up to 7 days postoperative
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Number of doses of ibuprofen 600 mg and paracetamol 1 g consumed during the first 7 postoperative days.
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Up to 7 days postoperative
|
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Patient global satisfaction
Délai: 7 days postoperative
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Overall satisfaction with the intervention evaluated at 7 days postoperative using a 100 mm visual analogue scale (0 = completely dissatisfied, 100 = completely satisfied).
|
7 days postoperative
|
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Days with limitation of daily activity
Délai: Up to 7 days postoperative
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Number of days with total or partial limitation of usual daily activity during the first 7 postoperative days.
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Up to 7 days postoperative
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Octavi Camps Font, University of Barcelona
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 26/2026
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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