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

NCT07667855 | Not Yet Recruiting DMC

• 1 other identifier: 2025-H-0185-D-M-0914
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thin Peri-implant Mucosal Phenotype

Keywords

Microneedling; Injectable Platelet-Rich Fibrin; i-PRF; Peri-implant soft tissue augmentation; Implant Esthetics; Mucosal Thickness; Connective Tissue Graft

Outcome Measures

Primary Outcomes (1)

• Mucosal Thickness

  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

Secondary Outcomes (7)

• Keratinized Tissue Width (KTW)

  Baseline to 8 Weeks

• Peri-implant Probing Depth (PD)

  Baseline to 8 Weeks

• Bleeding on Probing (BOP)

  Baseline to 8 Weeks

• Volumetric Soft Tissue Contour Change

  Baseline to 8 weeks

• Pink Esthetic Score (PES)

  6 Months

Study Arms (2)

Connective Tissue Graft

ACTIVE COMPARATOR

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.

Procedure: Connective Tissue Graft (CTG)

Microneedling + Injectable Platelet-Rich Fibrin (MN+i-PRF)

EXPERIMENTAL

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.

Procedure: Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF)

Interventions

Connective Tissue Graft (CTG) PROCEDURE

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.

Connective Tissue Graft

Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF) PROCEDURE

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.

Microneedling + Injectable Platelet-Rich Fibrin (MN+i-PRF)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (1)

Beirut Arab University

Beirut, Lebanon

Location

Related Publications (5)

• 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.

  PMID: 41910803 RESULT

• 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.

  PMID: 40264081 RESULT

• 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.

  PMID: 39337077 RESULT

• 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.

  PMID: 38188907 RESULT

• 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.

  PMID: 38128879 RESULT

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Nayer Aboelsaad, PHD

  Beirut Arab University

  STUDY CHAIR

Central Study Contacts

Ranim Ahmad, Msc Oral & Dental Surgery

CONTACT

+961 79129351; raneem-ahmad1998@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors responsible for clinical measurements, peri-implant soft tissue evaluations, Pink Esthetic Score assessment, intraoral scan analysis, and data collection will be blinded to treatment allocation. Due to the nature of the interventions, blinding of participants and care providers is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and chairperson of Periodontology Department

Model Details: This study is a prospective, parallel-arm, randomized controlled clinical trial. Eligible participants requiring peri-implant soft tissue augmentation during second-stage implant surgery will be randomly assigned in a 1:1 ratio to either a connective tissue graft (CTG) group or a microneedling with injectable platelet-rich fibrin (MN+i-PRF) group. Participants will remain in their assigned group throughout the study, and outcomes will be evaluated over a 9-month follow-up period.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): March 26, 2027
• Last Updated: June 25, 2026

Record last verified: 2025-10

Locations

LE (1)