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Completed

NCT Number: NCT05448040

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

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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Key information

Conditions

Socket Sealing Collagen Membrane Free Gingival Graft

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UM - POM Dpt

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Socket preservation

Procedure

Tooth extraction and preservation with a biomaterial

Primary outcomes

  1. Radiographic and clinical analysis

    Time frame: 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 outcomes

  1. Histological analysis - Gingiva

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Universidade Salgado de Oliveira

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 7, 2022
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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