Clinical and Histological Assessment of Free Gingival Graft or Collagen Matrix for Socket Sealing After Bone Grafting

Universidade Salgado de Oliveira

Status: Completed

Conditions: Socket Sealing; Collagen Membrane; Free Gingival Graft

Treatments: Procedure: Socket preservation

Study type: Interventional

Funder types: Other

Identifiers

NCT05448040

370723 14.4.0000.5374

Details and patient eligibility

About

The goal of this study was to compare, clinical and histologically, the use of the suine collagen matrix (Mucograft Seal [MS], Geisthlich®) and the free gingival graft (FGG) for the alveolar sealing after inserted bone graft biomaterial. It was included 18 patients with tooth referred to extraction (maxilar incisives, canines, or pre-molars) which were randomly divided in 2 groups, according to the material for alveolus sealing: control (FGG) and test (MS). After the minimally traumatic extraction, all the alveoli were filled with bovine mineral matrix (Bio-Oss®), and the material for alveolar sealing were positioned and stabilized with sutures. The follow-up (clinical and photographic) happened on the immediate post-operatory period, and with 3, 7, 15, 30, 60, 90, and 120 days. After 120 days, before implant placement, tissues samples were obtained with a 3.5mm punch scalpel for histological analysis. Qualitative information related to the patient's perception considering the treatment were collected.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• patients ASA I
• patients requiring single tooth extraction in the site between #4 to #13
• patients without enough bone volume for immediate implant placement.

Exclusion criteria

• patients with general contraindications for implant surgery
• pregnant or lactating women
• patients with untreated periodontitis
• bruxism or severe clenching
• immunosuppressed
• patients with a previous history of irradiation of the head and neck area
• uncontrolled diabetes
• heavy smoker (>10 cigarettes/day)
• poor oral hygiene and low motivation
• use of bisphosphonates
• substance abuse such as alcohol or drugs and psychiatric disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

18 participants in 2 patient groups

Collagen

Experimental group

Description:

This group received a bone graft (xenograft) and had the socket covered with a collagen membrane, in order to protect the bone graft inserted and seal the socket.

Treatment:

Procedure: Socket preservation

Free gingival graft

Experimental group

Description:

This group received a bone graft (xenograft) biomaterial and had the socket covered with a free gingival graft material, in order to protect the bone graft inserted and seal the socket.

Treatment:

Procedure: Socket preservation