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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05448040
Enrollment
18
Registered
2022-07-07
Start date
2018-02-01
Completion date
2021-11-30
Last updated
2022-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Collagen Membrane, Free Gingival Graft, Socket Sealing

Keywords

Alveolar sealing, Free gingival graft, Autogenous graft, Collagen matrix

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.

Interventions

PROCEDURESocket preservation

Tooth extraction and preservation with a biomaterial

Sponsors

Universidade Salgado de Oliveira
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic and clinical analysis6 monthsSocket 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

MeasureTime frameDescription
Histological analysis - Gingiva6 monthsGingival thickness obtained from the local tissue was evaluated through histological analysis (optical binocular microscope); assessment of the epithelial and connective layers (micrometers).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026