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

Free Gingival Graft Clinical Trial

Official title:

Clinical and Histological Assessment of Free Gingival Graft or Collagen Matrix for Socket Sealing After Bone Grafting: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05448040
• Other study ID #: 370723 14.4.0000.5374
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2022
• Source: Universidade Salgado de Oliveira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 30, 2021
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Free Gingival Graft

Intervention

Procedure:
• Socket preservation
Tooth extraction and preservation with a biomaterial

Locations

Country	Name	City	State
United States	UM - POM Dpt	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Salgado de Oliveira

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic and clinical analysis	Socket preservation with xenograft biomaterial and another one to seal it (FGG or collagen membrane).; Radiographic analysis - PA (periapical x-rays) comparing groups and periods of the follow-up. It was performed descriptive comparative analysis.; Clinical evaluation - bleeding on probing (dichotomic analysis), ISQ (torque achieved - Osstell), qualitative analysis (questionnaire with 8 questions), and subjective appraisal of the soft tissue healing (according to the period of evaluation).	6 months
Secondary	Histological analysis - Gingiva	Gingival thickness obtained from the local tissue was evaluated through histological analysis (optical binocular microscope); assessment of the epithelial and connective layers (micrometers).	6 months