Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions

Last updated: June 26, 2023
Sponsor: University of Turin, Italy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Use of XCM for the treatment of MAGRs with mCAF technique

Treatment of MAGRs with CTG

Clinical Study ID

NCT05693753
XCMTurin
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary aim of this study is to evaluate whether the use of a xenogenic collagen matrix (XCM) for the treatment of multiple adjacent gingival recessions (MAGRs) with a multiple coronally advanced flap technique (mCAF) achieves better results than the use of an autologous connective tissue graft (CTG) in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding). The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM is not inferior to CTG in terms of recessions reduction and secondary clinical variables, and superior regarding to PROMs.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years old and able to sign informed consent
  • At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions withoutinterproximal exposure of the CEJ (interdental gingival recession), at least one witha depth of ≥2mm with indication for root coverage treatment
  • A minimum of 4 adjacent teeth (including the ones to be treated) in the region ofinterest
  • Available to attend study related procedures (including follow-up visits)

Exclusion

Exclusion Criteria:

  • Systemic diseases/medications which could influence the outcome of the therapy (e.g.,uncontrolled diabetes mellitus);
  • Current smokers (self-reported, any type of smoking), users of chewing tobacco, anddrug/alcohol abusers;
  • Pregnant or nursing women;
  • History of previous periodontal surgery (mucogingival or other) on the teeth to beincluded;
  • Furcation involvement in the teeth to be included;
  • Presence of severe tooth malposition, rotation or clinically significant extrusion inthe teeth to be treated;
  • Presence of fixed or removable prosthesis in the area to be treated

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Use of XCM for the treatment of MAGRs with mCAF technique
Phase:
Study Start date:
February 02, 2023
Estimated Completion Date:
December 02, 2024

Connect with a study center

  • CIR Dental School

    Turin, 10126
    Italy

    Active - Recruiting

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