The Healing of Soft Tissue Augmentation by Acellular Dermal Matrix and Autogenous Subepithelial Connective Tissue Graft

University of Florida

Status: Withdrawn

Conditions: Graft Reaction; Gingival Recession, Generalized

Treatments: Procedure: Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03954028

IRB201900963

Details and patient eligibility

About

The study team proposes to prospectively compare the healing outcomes of autogenous soft tissue connective tissue graft (CTG) and Acellular dermis matrix (ADM) in a split-mouth design study for patients requiring modification of gingival soft tissue biotype. The researchers aim to investigate the earlier phase of graft healing after the grafting surgery by biopsy histology and by examining the alteration of gene profile during the healing of gingival tissue healing by molecular cell biological techniques.

Full description

The investigators will perform a prospective clinical randomized controlled trial, and recruit 12 patients who need gingival soft tissue augmentation. It is a split-mouth design: CTG will be used in one side of soft tissue augmentation, and ADM will be used on the other side. 3 months after graft healing, clinical measurements including soft tissue thickness, transparency visualization, tissue profile record with impression cast study model, and digital photography of tissue will be performed. The gingival punch biopsies ( 2mm diameters) will be performed in both sides of grafting areas under the local oral anesthesia injection. The collected tissue will be split into two halves, one for histological examination, and another half for gene analysis.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• general healthy
• periodontal healthy (no PD >3mm, no BOP, no mobility at the test site and control site)
• patients identified need gingival biotype modification (need for increased tissue thickness) during the periodontal exam or referred from orthodontics

Exclusion criteria

• current smoker or smoking history
• taking Antibiotics or medicines within the last 3 months
• past history of gingival soft tissue augmentation/modification surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

CTG Group

Active Comparator group

Description:

Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. In this group, the autogenous connective tissue graft (CTG) material will be randomized to transplant to one side of the arch.

Treatment:

Procedure: Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation

ADM Group

Active Comparator group

Description:

The patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. In this group, the commercial acellular dermal matrix (ADM) materials will be transplanted to the opposite side of the arch with CTG transplants.

Treatment:

Procedure: Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation