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

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

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.

Study Overview

• Status: Completed
• Conditions: Free Gingival Graft; Socket Sealing; Collagen Membrane
• Intervention / Treatment: Procedure: Socket preservation

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • UM - POM Dpt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Collagen; 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.	Procedure: Socket preservation; Tooth extraction and preservation with a biomaterial
EXPERIMENTAL: Free gingival graft; 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.	Procedure: Socket preservation; Tooth extraction and preservation with a biomaterial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidade Salgado de Oliveira
• Investigators: Principal Investigator: Joly, PhD, Sao Leopoldo Mandic

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): September 18, 2020
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (ACTUAL): July 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Free gingival graft; Collagen matrix; Alveolar sealing; Autogenous graft
• Other Study ID Numbers: 370723 14.4.0000.5374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No