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Completed

NCT Number: NCT06006780

Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Porcine acellular dermal matrix

Device

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

Other names: Mucoderm

Coronally advanced flap (CAF)

Other

Coronally advanced flap for root coverage

Primary outcomes

  1. Recession change

    Time frame: Baseline, 6 months and 12 months

    Change of the gingival recession height

Secondary outcomes

  1. Thickness of keratinized tissue

    Time frame: Baseline, 6 months and 12 months

    Thickness of keratinized tissue evaluation after periodontal plastic surgery

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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