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

Gingival Recession, Generalized Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03954028
• Other study ID #: IRB201900963
• Status: Withdrawn
• Phase: N/A
• Start date: March 2021
• Est. completion date: March 2022

Study information

• Verified date: April 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Generalized
• Graft Reaction

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Dentsply Implants Manufacturing GmbH

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Erratum in: J Periodontol 2002 Jun;73(6):684. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in the gingival biotype analysis before and after 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)
Other	The healing time of the gingival biopsy sites	The gingival wound healing after biopsy will be compared between the sites	Up to 7 days after gingival biopsy
Primary	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	The immunohistological analysis of the gingival biopsy.	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
Secondary	RT-qPCR analysis of gingival biopsy.	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