Clinical trial NCT06006780: Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions
Official title: Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions: A Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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\&#39;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\&#39;s test. Key words: Gingival recession, Root coverage, Biomaterial, Acellular dermal matrix.


Eligibility criteria: Inclusion Criteria:

* RT1 localized gingival recessions with height ranging from 3 to 5 mm;
* 2mm or more of keratinized tissue width ;
* Probing depth less than 3mm;
* Plaque and gingival index less or equal to 20%.

Exclusion Criteria:

* Smokers;
* Pregnants;
* Nursing;
* Patients with diabetes mellitus or another condition that interfere in the tissue repair
* Patients who use drugs or medications that interfere in the tissue repair;
* Allergies to any composition of the devices of the study.

Primary outcomes:
measure: Recession change
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Thickness of keratinized tissue
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School, State University of Campinas
state: São Paulo
Study officials:
References:
citation: Sangiorgio JPM, Neves FLDS, Rocha Dos Santos M, Franca-Grohmann IL, Casarin RCV, Casati MZ, Santamaria MP, Sallum EA. Xenogenous Collagen Matrix and/or Enamel Matrix Derivative for Treatment of Localized Gingival Recessions: A Randomized Clinical Trial. Part I: Clinical Outcomes. J Periodontol. 2017 Dec;88(12):1309-1318. doi: 10.1902/jop.2017.170126. Epub 2017 Jul 28.