- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07667855
Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft
Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft: A Randomized Controlled Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Peri-implant soft tissue quality is a key determinant of implant health, long-term stability, and esthetic outcomes. Adequate peri-implant mucosal thickness and keratinized tissue width contribute to the maintenance of peri-implant health, while thin soft tissue phenotypes have been associated with increased risk of recession, discomfort during oral hygiene procedures, and peri-implant tissue complications. Connective tissue grafting (CTG) remains the gold standard for peri-implant soft tissue augmentation; however, it requires harvesting autogenous tissue from a secondary donor site, resulting in increased surgical morbidity, postoperative discomfort, and longer treatment time.
Recent regenerative approaches have focused on the use of injectable platelet-rich fibrin (i-PRF), an autologous blood-derived concentrate rich in platelets, leukocytes, fibrin, and growth factors that promote angiogenesis, collagen formation, and soft tissue healing. Microneedling is a minimally invasive technique that creates controlled micro-injuries within the soft tissues, stimulating collagen production and enhancing the penetration and biological effects of regenerative agents. Preliminary evidence suggests that combining microneedling with i-PRF may enhance peri-implant soft tissue thickness and quality while minimizing patient morbidity.
This study is designed as a prospective, parallel-arm randomized controlled clinical trial comparing microneedling combined with injectable platelet-rich fibrin (MN+i-PRF) with connective tissue grafting (CTG) for peri-implant soft tissue augmentation during implant second-stage surgery. Approximately 24 eligible participants presenting with thin peri-implant soft tissue phenotype in the esthetic zone will be randomly allocated in a 1:1 ratio to either the test or control group. Allocation concealment will be performed using computer-generated randomization and sealed opaque envelopes. Outcome assessors will be blinded to treatment allocation.
Participants in the control group will undergo peri-implant soft tissue augmentation using a subepithelial connective tissue graft harvested from the palate and stabilized at the buccal aspect of the implant site. Participants in the test group will receive microneedling using a sterile automated microneedling device followed by injection of autologous i-PRF into the peri-implant mucosa. The test intervention will be performed at implant uncovery and repeated at 2-week and 4-week follow-up visits to maximize regenerative effects.
The primary outcome measure will be the change in peri-implant mucosal thickness from baseline. Secondary outcome measures will include keratinized tissue width, peri-implant probing depth, bleeding on probing, volumetric soft tissue contour changes assessed through intraoral scanning, Pink Esthetic Score (PES), and patient-reported outcome measures including postoperative pain and treatment satisfaction. Clinical and patient-centered outcomes will be evaluated at predefined follow-up intervals extending up to 9 months after treatment.
The objective of this study is to determine whether microneedling combined with i-PRF can provide peri-implant soft tissue augmentation outcomes comparable to connective tissue grafting while reducing treatment invasiveness and patient morbidity. The findings may contribute to the development of minimally invasive regenerative approaches for peri-implant phenotype modification and esthetic enhancement.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ranim Ahmad, Msc Oral & Dental Surgery
- Numéro de téléphone: +961 79129351
- E-mail: raneem-ahmad1998@hotmail.com
Lieux d'étude
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Beirut, Liban
- Beirut Arab University
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Contact:
- Nayer Aboelsaad, Phd
- Numéro de téléphone: +96179109899
- E-mail: naier74@gmail.com
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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:
- Systemically healthy adults (Between 18 and 65) with one or more dental implants requiring second-stage surgery in the esthetic zone (Anteriors and Premolars).
- Thin soft tissue phenotype: mucosal thickness or KTW <2 mm buccally.
- Stable osseointegrated implant, adequate restorative space, and healthy adjacent teeth.
- Good oral hygiene (PI ≤10%), with peri-implant maintenance.
- Signed consent + willingness for 1-year follow-up.
Exclusion Criteria:
- Heavy smokers (≥10 cig/day); light smokers only if reduced.
- Systemic/healing issues: uncontrolled diabetes, immunocompromise, bleeding disorders, anticoagulants, steroids.
- Pregnancy or breastfeeding.
- Active infection (periodontal or peri-implant).
- No residual keratinized mucosa on buccal side.
- Previous graft/augmentation at the site or recent surgery (<6 months).
- Allergies to anesthetics/materials.
- Non-compliance with instructions or follow-up.
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 |
|---|---|
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Comparateur actif: Connective Tissue Graft
Participants will receive peri-implant soft tissue augmentation using a subepithelial connective tissue graft harvested from the palate during implant second-stage surgery.
The graft will be placed at the buccal aspect of the implant site to increase peri-implant mucosal thickness and improve soft tissue phenotype stability.
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Peri-implant soft tissue augmentation performed using a subepithelial connective tissue graft harvested from the palate during implant second-stage surgery.
The graft is placed at the buccal aspect of the implant site to increase mucosal thickness and improve peri-implant soft tissue phenotype.
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Expérimental: Microneedling + Injectable Platelet-Rich Fibrin (MN+i-PRF)
Participants will receive peri-implant soft tissue augmentation using microneedling with a sterile automated microneedling device followed by injection of autologous injectable platelet-rich fibrin (i-PRF).
The procedure will be performed during implant second-stage surgery and repeated at 2 and 4 weeks postoperatively.
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Peri-implant soft tissue augmentation performed using automated microneedling followed by injection of autologous injectable platelet-rich fibrin (i-PRF) during implant second-stage surgery.
The intervention is repeated at 2 and 4 weeks postoperatively to enhance peri-implant soft tissue thickness and quality.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mucosal Thickness
Délai: Baseline to 8 Weeks
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Change in buccal peri-implant mucosal thickness (mm) measured at the mid-facial aspect, 2 mm apical to the mucosal margin, using standardized transgingival probing through a custom stent.
Measurements will be compared between baseline and follow-up examinations.
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Baseline to 8 Weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Keratinized Tissue Width (KTW)
Délai: Baseline to 8 Weeks
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Change in keratinized tissue width (mm) measured at the mid-facial aspect from the mucosal margin to the mucogingival junction using a calibrated periodontal probe.
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Baseline to 8 Weeks
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Peri-implant Probing Depth (PD)
Délai: Baseline to 8 Weeks
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Peri-implant probing depth (mm) measured at four sites per implant (mesiobuccal, mid-buccal, distobuccal, and lingual/palatal) using a calibrated periodontal probe and standardized probing force.
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Baseline to 8 Weeks
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Bleeding on Probing (BOP)
Délai: Baseline to 8 Weeks
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Presence or absence of bleeding following gentle periodontal probing at four peri-implant sites.
Bleeding on probing will be recorded as an indicator of peri-implant soft tissue health.
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Baseline to 8 Weeks
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Volumetric Soft Tissue Contour Change
Délai: Baseline to 8 weeks
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Volumetric changes in peri-implant soft tissues assessed using intraoral digital scans and three-dimensional superimposition of STL files obtained at baseline and follow-up visits.
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Baseline to 8 weeks
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Pink Esthetic Score (PES)
Délai: 6 Months
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Esthetic evaluation of peri-implant soft tissues using the Pink Esthetic Score.
Standardized clinical photographs will be assessed to evaluate papilla fill, soft tissue contour, level, color, and texture around the implant restoration.
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6 Months
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Postoperative Pain
Délai: 24 Hours and 72 Hours Postoperatively
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Participant-reported postoperative pain measured using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
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24 Hours and 72 Hours Postoperatively
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Patient Satisfaction
Délai: 8 Weeks
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Participant satisfaction regarding treatment comfort, esthetic outcome, and willingness to undergo the procedure again, measured using a 10-point Visual Analog Scale (VAS).
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8 Weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Nayer Aboelsaad, PHD, Beirut Arab University
Publications et liens utiles
Publications générales
- Ayyildiz BG, Eken S, Terzioglu B. The effect of the injectable platelet-rich fibrin on peri-implant soft tissue phenotype: a preliminary, prospective, 12-month follow-up clinical study. Clin Oral Investig. 2026 Mar 30;30(4):159. doi: 10.1007/s00784-026-06849-0.
- Giammarinaro E, Baldini N, Covani U, Menini M, Pesce P, Marconcini S. Does platelet-rich fibrin enhance the outcomes of peri-implant soft tissues? A systematic review. BMC Oral Health. 2025 Apr 22;25(1):615. doi: 10.1186/s12903-025-05922-6.
- Zurek J, Niemczyk W, Dominiak M, Niemczyk S, Wiench R, Skaba D. Gingival Augmentation Using Injectable Platelet-Rich Fibrin (i-PRF)-A Systematic Review of Randomized Controlled Trials. J Clin Med. 2024 Sep 20;13(18):5591. doi: 10.3390/jcm13185591.
- Chetana, Sidharthan S, Dharmarajan G, Iyer S, Poulose M, Guruprasad M, Chordia D. Evaluation of microneedling with and without injectable-platelet rich fibrin for gingival augmentation in thin gingival phenotype-A randomized clinical trial. J Oral Biol Craniofac Res. 2024 Jan-Feb;14(1):49-54. doi: 10.1016/j.jobcr.2023.10.008. Epub 2023 Dec 15.
- Valli Veluri S, Gottumukkala SN, Penmetsa GS, Ramesh K, P MK, Bypalli V, Vundavalli S, Gera D. Clinical and patient-reported outcomes of periodontal phenotype modification therapy using injectable platelet rich fibrin with microneedling and free gingival grafts: A prospective clinical trial. J Stomatol Oral Maxillofac Surg. 2024 Sep;125(4):101744. doi: 10.1016/j.jormas.2023.101744. Epub 2023 Dec 19.
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-H-0185-D-M-0914
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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