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

Conditions

• Keratinized Tissue Augmentation Around Dental Implants

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Augmented Gingival Matrix graft — DEVICE
  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 — PROCEDURE
  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.

Study Details

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)

Key Dates

First listed

Oct 7, 2026

Start date

Nov 1, 2026

Status verified

Oct 2026

Primary completion

Jun 30, 2028

Completion

Oct 31, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Augmented Gingival Matrix graft
  A biomaterial, namely the Augmented Gingival Matrix (AGM) barrier, will be used as the Test product. It is a bovine-derived, three-layered structure with two external gelatin fiber layers and a central polycaprolactone (PCL) layer. This is an FDA-cleared device.
• Active Comparator: Free Gingival Graft
  Free Gingival Graft obtained from the palatal area will serve as the gold-standard control group.

Primary Outcome Measure

Change in keratinized tissue width [ Time Frame: 6 months ]

Locations (1)

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