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

June 19, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Beirut Arab University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Connective Tissue Graft (CTG)
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.
Experimental: 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.
Procedure: Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucosal Thickness
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized Tissue Width (KTW)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beirut Arab University

Investigators

  • Study Chair: Nayer Aboelsaad, PHD, Beirut Arab University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 26, 2026

Primary Completion (Estimated)

February 26, 2027

Study Completion (Estimated)

March 26, 2027

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-H-0185-D-M-0914

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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