Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions A Multicenter Randomized Clinical Trial.

Gingival Recession Clinical Trial

Official title:

Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions: A Multicenter Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006780
• Other study ID #: 59036822.4.1001.5418
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: August 2023
• Source: University of Campinas, Brazil
• Contact: Enilson A. Sallum, PhD
• Phone: +55(19)2106-5301
• Email: easallum[@]fop.unicamp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: The aim of this randomized clinical trial is to evaluate the use of the porcine acellular dermal matrix (PADM) for the treatment of RT1 localized gingival recessions.

Material and methods: Forthy patients (n=20) with RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be selected to participate in the study. Patients will be allocated randomly in two treatment groups: Coronally advanced flap (CAF) or coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM). The clinical parameters evaluated at the baseline, 6 and 12 months will be: Plaque index (IPL); gingival index (GI); relative gingival recession height (RGRH); gingival recession width (GRW); probing depth (PD); relative clinical attachment level (RCAL); keratinized tissue height (KTH); keratinized tissue thickness (KTT); papilla height (PH). Evaluations will be made by the professional and the patient regarding dentin hypersensitivity (HD) (Schiff and VAS scales respectively), aesthetics (RES and VAS scales, respectively) and patient's centered outcomes, through the questionnaire referring to the OHIP-14.

Descriptive statistical analysis will be expressed as mean ± standard deviation (SD), median, quartiles, percentages and confidence intervals (95% CI). To analyze the normality of the residue, the Shapiro-Wilk test will be performed. Then, the Wilcoxon test will be applied to compare the periodontal parameters and a quality of life, before and post-treatment. Correlations between parameters and dental hypersensitivity will be analyzed through Spearman's test. Key words: Gingival recession, Root coverage, Biomaterial, Acellular dermal matrix.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 20, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be selected to participate in the study; probing depth <3mm, plaque and gingival index < or = a 20%.

Exclusion Criteria:

• Smokers, pregnants, nursing, patients with diabetes mellitus or another condition who interfere in the tissue repair, use of drugs or medications, allergies to any composition of the devices of the study.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Device:
• Porcine acellular dermal matrix
Coronally advanced flap associated with the porcine acellular dermal matrix for root coverage

Other:
• Coronally advanced flap (CAF)
Coronally advanced flap for root coverage

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School, State University of Campinas	Piracicaba	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recession reduction	Reduction of the gingival recession height	Baseline, 6 months and 12 months
Secondary	Thickness of keratinized tissue	Thickness of keratinized tissue evaluation after periodontal plastic surgery	Baseline, 6 months and 12 months