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

Not Applicable

Withdrawn

• Conditions: Graft Reaction; Gingival Recession, Generalized
• Interventions: Procedure: Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation

• Registration Number: NCT03954028
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-17
• Study Start: 2021-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTG Group	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. In this group, the autogenous connective tissue graft (CTG) material will be randomized to transplant to one side of the arch.
ADM Group	Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation	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.

Primary Outcome Measures

Name	Time	Method
The histological analysis of the gingival biopsy tissue.	Month 3---after the gingival biopsy procedures	Histological analysis with standard coloration will assess the epithelium and underneath connective tissue within the gingival biopsy tissue. Signs of inflammation (ulcerations, infiltration of neutrophil cells, vessel structure) will be noted.

Secondary Outcome Measures

Name	Time	Method
The immunohistological analysis of the gingival biopsy.	Month 3---after the gingival biopsy procedures	Immunohistological analysis using specific antibodies will locate the epithelium (collagen IV), the smooth muscle (Smooth muscle actin), and re-innvervation (protein gene product 9.5, calcitonin-related gene product) according to the similar study by Perotto, et al. 2017.
RT-qPCR analysis of gingival biopsy.	Month 3---after the gingival biopsy procedures	The RT-qPCR analysis will measure the level of expression (compared to the housekeeping gene GAPDH) of RNA specific to the epithelium (collagen IV), the smooth muscle (Smooth muscle actin), re-innvervation (protein gene product 9.5, calcitonin-related gene product) and inflammation (IL-1, IL-6, MMP-8, TNF-alpha).