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

Sponsor
University of Campinas, Brazil (Other)
Overall Status
Recruiting
CT.gov ID
NCT06006780
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
27.3
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Porcine acellular dermal matrix
  • Other: Coronally advanced flap (CAF)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions: A Multicenter Randomized Clinical Trial
Actual Study Start Date :
Sep 10, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Dec 20, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Recession reduction [Baseline, 6 months and 12 months]

      Reduction of the gingival recession height

    Secondary Outcome Measures

    1. Thickness of keratinized tissue [Baseline, 6 months and 12 months]

      Thickness of keratinized tissue evaluation after periodontal plastic surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Piracicaba Dental School, State University of Campinas Piracicaba São Paulo Brazil 13414-903

    Sponsors and Collaborators

    • University of Campinas, Brazil

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Enilson Antonio Sallum, PhD, Chair of Periodontolgy Area, University of Campinas, Brazil
    ClinicalTrials.gov Identifier:
    NCT06006780
    Other Study ID Numbers:
    • 59036822.4.1001.5418
    First Posted:
    Aug 23, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    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
    Additional relevant MeSH terms:
    Gingival Recession

    Study Results

    No Results Posted as of Aug 23, 2023