Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft

19 juin 2026 mis à jour par: Nayer Aboelsaad, Beirut Arab University

Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft: A Randomized Controlled Clinical Trial

This randomized controlled clinical trial aims to evaluate a minimally invasive technique for peri-implant soft tissue augmentation using microneedling combined with injectable platelet-rich fibrin (i-PRF) compared with the current gold-standard connective tissue graft (CTG). Patients with thin peri-implant soft tissue requiring implant second-stage surgery in the esthetic zone will be randomly assigned to receive either CTG harvested from the palate or a series of microneedling and i-PRF treatments. Clinical outcomes including mucosal thickness, keratinized tissue width, peri-implant health parameters, volumetric soft tissue changes, esthetic outcomes, and patient-reported measures of pain and satisfaction will be evaluated during follow-up. The study aims to determine whether microneedling with i-PRF can provide comparable soft tissue augmentation while reducing patient morbidity associated with connective tissue graft harvesting.

Aperçu de l'étude

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

Interventionnel

Inscription (Estimé)

24

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • Beirut, Liban
        • Beirut Arab University
        • Contact:
          • Nayer Aboelsaad, Phd
          • Numéro de téléphone: +96179109899
          • E-mail: naier74@gmail.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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: 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.
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.
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.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mucosal Thickness
Délai: Baseline to 8 Weeks
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.
Baseline to 8 Weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Keratinized Tissue Width (KTW)
Délai: Baseline to 8 Weeks
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.
Baseline to 8 Weeks
Peri-implant Probing Depth (PD)
Délai: Baseline to 8 Weeks
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.
Baseline to 8 Weeks
Bleeding on Probing (BOP)
Délai: Baseline to 8 Weeks
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.
Baseline to 8 Weeks
Volumetric Soft Tissue Contour Change
Délai: Baseline to 8 weeks
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.
Baseline to 8 weeks
Pink Esthetic Score (PES)
Délai: 6 Months
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.
6 Months
Postoperative Pain
Délai: 24 Hours and 72 Hours Postoperatively
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.
24 Hours and 72 Hours Postoperatively
Patient Satisfaction
Délai: 8 Weeks
Participant satisfaction regarding treatment comfort, esthetic outcome, and willingness to undergo the procedure again, measured using a 10-point Visual Analog Scale (VAS).
8 Weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Nayer Aboelsaad, PHD, Beirut Arab University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

26 juin 2026

Achèvement primaire (Estimé)

26 février 2027

Achèvement de l'étude (Estimé)

26 mars 2027

Dates d'inscription aux études

Première soumission

19 juin 2026

Première soumission répondant aux critères de contrôle qualité

19 juin 2026

Première publication (Réel)

25 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 juin 2026

Dernière vérification

1 octobre 2025

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner