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Keratinized Tissue Augmentation Using Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants
Sponsor: The Forsyth Institute
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
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).
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