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NOT YET RECRUITING
NCT07667855
NA

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

Sponsor: Beirut Arab University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-06-26

Completion Date

2027-03-26

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

Beirut Arab University

Beirut, Lebanon