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

Sponsor

Universidade Salgado de Oliveira (Other)

Overall Status

Completed

CT.gov ID

NCT05448040

Collaborator

(none)

Enrollment

Location

Arms

45.9

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Socket Sealing Free Gingival Graft Collagen Membrane	Procedure: Socket preservation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Sep 18, 2020

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Radiographic and clinical analysis [6 months]
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).

Secondary Outcome Measures

Histological analysis - Gingiva [6 months]
Gingival thickness obtained from the local tissue was evaluated through histological analysis (optical binocular microscope); assessment of the epithelial and connective layers (micrometers).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UM - POM Dpt	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

Universidade Salgado de Oliveira

Investigators

Principal Investigator: Joly, PhD, Sao Leopoldo Mandic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gustavo Fernandes, DDS, MSc, PhD, Clinical Lecturer, University of Michigan

ClinicalTrials.gov Identifier:

NCT05448040

Other Study ID Numbers:

370723 14.4.0000.5374

First Posted:

Jul 7, 2022

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gustavo Fernandes, DDS, MSc, PhD, Clinical Lecturer, University of Michigan

Study Results

No Results Posted as of Jul 7, 2022