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

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gingival Recession, Generalized Graft Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. The autogenous connective tissue (CTG) graft material will be randomized to apply to one half, and commercial acellular dermal matrix (ADM) materials will be used in the opposite half.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The biopsy sites will be coded alphanumerically. The investigator performing the gingival grafts will be different from the examiner performing the gingival biopsies. The examiner performing the gingival biopsies will be blinded to the grafting type source of the biopsy sites.The results from coded samples will be reported to the PI, who will summarize the data.

Study Groups

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CTG Group

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.

Group Type ACTIVE_COMPARATOR

Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation

Intervention Type PROCEDURE

Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. The autogenous connective tissue (CTG) graft material will be randomized to apply to one half, and commercial acellular dermal matrix (ADM) materials will be used in the opposite half. After 3 months of healing, a gingival punch biopsy will be performed in both sides to collect the tissues for analysis.

ADM Group

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.

Group Type ACTIVE_COMPARATOR

Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation

Intervention Type PROCEDURE

Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. The autogenous connective tissue (CTG) graft material will be randomized to apply to one half, and commercial acellular dermal matrix (ADM) materials will be used in the opposite half. After 3 months of healing, a gingival punch biopsy will be performed in both sides to collect the tissues for analysis.

Interventions

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Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation

Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. The autogenous connective tissue (CTG) graft material will be randomized to apply to one half, and commercial acellular dermal matrix (ADM) materials will be used in the opposite half. After 3 months of healing, a gingival punch biopsy will be performed in both sides to collect the tissues for analysis.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes