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

April 21, 2021 updated by: University of Florida

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Procedure: 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.
ACTIVE_COMPARATOR: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The histological analysis of the gingival biopsy tissue.
Time Frame: 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.
Month 3---after the gingival biopsy procedures

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The immunohistological analysis of the gingival biopsy.
Time Frame: 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.
Month 3---after the gingival biopsy procedures
RT-qPCR analysis of gingival biopsy.
Time Frame: 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).
Month 3---after the gingival biopsy procedures

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the gingival biotype analysis before and after grafting surgery
Time Frame: Baseline; Month 3 (before the gingival grafting surgery and before the gingival biopsy which is 3 months after gingival grafting surgery)
The gingival thickness measurement by visualization with periodontal probing, the soft tissue profile analysis with dental casts and digital photographs will be performed before the gingival grafting surgery and before the gingival biopsy which is 3 months after gingival grafting surgery.
Baseline; Month 3 (before the gingival grafting surgery and before the gingival biopsy which is 3 months after gingival grafting surgery)
The healing time of the gingival biopsy sites
Time Frame: Up to 7 days after gingival biopsy
The gingival wound healing after biopsy will be compared between the sites
Up to 7 days after gingival biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Dentsply Implants Manufacturing GmbH

Investigators

  • Principal Investigator: Jia Chang, DDS, MS, PhD, University of Florida College of Dentistry, Department of Periodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2021

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

April 26, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (ACTUAL)

May 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201900963

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual participant data sets are to be shared include all collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

The data will be available once the summary data are published.

IPD Sharing Access Criteria

The PI will review requests and criteria for reviewing requests.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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