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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2021-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Socket Sealing Free Gingival Graft Collagen Membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Socket preservation

Intervention Type PROCEDURE

Tooth extraction and preservation with a biomaterial

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.

Group Type EXPERIMENTAL

Socket preservation

Intervention Type PROCEDURE

Tooth extraction and preservation with a biomaterial

Interventions

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Socket preservation

Tooth extraction and preservation with a biomaterial

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes