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

Study Overview
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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.

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

Conditions
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Socket Sealing, Free Gingival Graft, Collagen Membrane

Intervention / Treatment
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* Procedure: Socket preservation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen<br>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<br>* Tooth extraction and preservation with a biomaterial<br>|
| Experimental: Free gingival graft<br>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<br>* Tooth extraction and preservation with a biomaterial<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alveolar sealing, Free gingival graft, Autogenous graft, Collagen matrix