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

NCT03954028 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-04-23

No results posted yet for this study

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.

Conditions

  • Gingival Recession, Generalized
  • Graft Reaction

Interventions

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.

Sponsors & Collaborators

  • Dentsply Implants Manufacturing GmbH

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Jia Chang, DDS, MS, PhD · University of Florida College of Dentistry, Department of Periodontology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2022-03-31
Completion
2022-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03954028 on ClinicalTrials.gov