Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions

NCT06006780 | Completed DMC

• 1 other identifier: 59036822.4.1001.5418
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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\'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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Recession change

  Change of the gingival recession height

  Baseline, 6 months and 12 months

Secondary Outcomes (1)

• Thickness of keratinized tissue

  Baseline, 6 months and 12 months

Study Arms (2)

Coronally advanced flap (CAF)

ACTIVE COMPARATOR

Other: Coronally advanced flap (CAF)

Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM)

EXPERIMENTAL

Device: Porcine acellular dermal matrix

Interventions

Porcine acellular dermal matrix DEVICE

Coronally advanced flap associated with the porcine acellular dermal matrix for root coverage

Also known as: Mucoderm

Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM)

Coronally advanced flap (CAF) OTHER

Coronally advanced flap for root coverage

Coronally advanced flap (CAF)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

Related Publications (1)

• 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.

  PMID: 28753100 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Chair of Periodontolgy Area

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: September 10, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)