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

NCT03954028 | Withdrawn

• 1 other identifier: IRB201900963
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Recession, Generalized; Graft Reaction

Outcome Measures

Primary Outcomes (1)

• The histological analysis of the gingival biopsy tissue.

  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 Outcomes (2)

• The immunohistological analysis of the gingival biopsy.

  Month 3---after the gingival biopsy procedures

• RT-qPCR analysis of gingival biopsy.

  Month 3---after the gingival biopsy procedures

Other Outcomes (2)

• change in the gingival biotype analysis before and after 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

  Up to 7 days after gingival biopsy

Study Arms (2)

CTG Group

ACTIVE COMPARATOR

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

ADM Group

ACTIVE COMPARATOR

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

Interventions

Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation 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; CTG Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead
• Dentsply Implants Manufacturing GmbH: collaborator

Related Publications (6)

• McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5.

  PMID: 24597764 BACKGROUND

• Cummings LC, Kaldahl WB, Allen EP. Histologic evaluation of autogenous connective tissue and acellular dermal matrix grafts in humans. J Periodontol. 2005 Feb;76(2):178-86. doi: 10.1902/jop.2005.76.2.178.

  PMID: 15974840 BACKGROUND

• de Resende DRB, Greghi SLA, Siqueira AF, Benfatti CAM, Damante CA, Ragghianti Zangrando MS. Acellular dermal matrix allograft versus free gingival graft: a histological evaluation and split-mouth randomized clinical trial. Clin Oral Investig. 2019 Feb;23(2):539-550. doi: 10.1007/s00784-018-2470-6. Epub 2018 Apr 30.

  PMID: 29713889 BACKGROUND

• Menceva Z, Dimitrovski O, Popovska M, Spasovski S, Spirov V, Petrushevska G. Free Gingival Graft versus Mucograft: Histological Evaluation. Open Access Maced J Med Sci. 2018 Mar 27;6(4):675-679. doi: 10.3889/oamjms.2018.127. eCollection 2018 Apr 15.

  PMID: 29731940 BACKGROUND

• Wei PC, Laurell L, Lingen MW, Geivelis M. Acellular dermal matrix allografts to achieve increased attached gingiva. Part 2. A histological comparative study. J Periodontol. 2002 Mar;73(3):257-65. doi: 10.1902/jop.2002.73.3.257.

  PMID: 11922254 BACKGROUND

• Perotto S, Romano F, Cricenti L, Gotti S, Aimetti M. Vascularization and Innervation of Connective Tissue Grafts in the Treatment of Gingival Recessions: A Histologic and Immunohistochemical Study. Int J Periodontics Restorative Dent. 2017 Jul/Aug;37(4):551-558. doi: 10.11607/prd.3020.

  PMID: 28609502 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Jia Chang, DDS, MS, PhD

  University of Florida College of Dentistry, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 17, 2019
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available once the summary data are published.
• Access Criteria: The PI will review requests and criteria for reviewing requests.