The Forsyth Institute
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)
This is a prospective, 12-month, randomized, examiner-blinded, controlled, two-arm, parallel-group, multi-site clinical trial with a 1:1 allocation ratio comparing Augmented Gingival Matrix barrier (AGM, test graft) with a free gingival graft (FGG; standard of care) around implants in medically healthy subjects. This randomized controlled clinical trial is designed to compare free gingival graft and AGM graft with respect to both effectiveness and safety when used around dental implants. The primary outcome will be the gain in keratinized tissue width after 12 months. Secondary outcomes will…
Inclusion Criteria: * • Willing and able to abide by the terms of the consent form and sign the Informed Consent form * Good general health as evidenced by medical history * Ages 18 and over * Edentulous or partially edentulous patients who had undergone dental implant surgery * Patients exhibiting KT/mucosa width of \>0.5 but \<2 mm at the buccal aspect of the implant, subjected to surgical intervention either at the time of second-stage surgery after placement of healing abutments (i.e., 3 to 5 months following submerged healing) or implants in function * Presence of peri-implant…
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).
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.
Arctuva estimate
Verify or correct the compensation shown for this listing.