Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Other: Coronally advanced flap (CAF); Device: Porcine acellular dermal matrix

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Piracicaba, São Paulo, Brazil, 13414-903
      • Piracicaba Dental School, State University of Campinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coronally advanced flap (CAF)	Other: Coronally advanced flap (CAF); Coronally advanced flap for root coverage
Experimental: Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM)	Device: Porcine acellular dermal matrix; Coronally advanced flap associated with the porcine acellular dermal matrix for root coverage; Other Names: Mucoderm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recession change	Change of the gingival recession height	Baseline, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness of keratinized tissue	Thickness of keratinized tissue evaluation after periodontal plastic surgery	Baseline, 6 months and 12 months

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: 59036822.4.1001.5418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No