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NOT YET RECRUITING
NCT07863882
NA

Keratinized Tissue Augmentation Using Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants

Sponsor: The Forsyth Institute

View on ClinicalTrials.gov

Summary

This is a 12-month, randomized, examiner-blinded, controlled, two-arm, parallel-group, single-site clinical trial comparing a biocompatible tissue graft (Augmented Gingival Matrix barrier) with a free gingival graft (FGG) to increase the keratinized tissue around implants in medically healthy subjects. Subjects will be enrolled in a balanced manner (1:1; treatment:control) into one of the 2 following treatment arms for keratinized tissue augmentation: 1. Group A: Augmented Gingival Matrix barrier (Test group) 2. Group B: Free gingival graft (Control Group)

Official title: A Randomized Controlled Clinical Trial to Assess Soft Tissue Quantity and Quality Following the Use of Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants-A 12-month Follow-up Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-11-01

Completion Date

2028-10-31

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

DEVICE

Augmented Gingival Matrix graft

After administration of local anesthesia (2% lidocaine/articaine, 1:100.000 epinephrine), implant sites undergoing a simultaneous second-stage surgery will be uncovered, and healing abutments will be inserted. The recipient bed will be prepared using a 15-stainless steel blade by performing a horizontal split-thickness incision above the mucogingival junction (MGJ) on the attached gingiva at the buccal aspect of the implants. The AGM graft will be processed according to the manufacturer's instructions. The graft will be trimmed to fit the recipient bed and secured using interrupted sutures (e.g., 5-0 or 6-0 monofilament).

PROCEDURE

Free Gingival Graft

Recipient bed preparation will be similar to the AGM intervention. A free gingival graft will be harvested from the palate, typically 1.5-2.0 mm thick, aiming for dimensions suitable for the recipient site. The graft will be trimmed and secured to the recipient bed using interrupted sutures (e.g., 5-0 or 6-0 monofilament suture. A periodontal dressing will be placed over the donor site.

Locations (1)

ADA Forsyth Institute

Somerville, Massachusetts, United States