Clinical Trial: Novel Porcine Dermal Matrix in the Treatment of Multiple Adjacent Gingival Recessions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Novel Porcine Dermal Matrix Vs. Connective Tissue Graft in the Treatment of Multiple Adjacent Gingival Recessions of Miller Class I and II: a 12-month Randomized Controlled Clinical Trial

Brief Summary: The aim of this study was to assess the clinical efficacy of the acellular porcine derived collagen matrix (PADM) in comparison with connective tissue graft (SCTG ) in the treatment of multiple adjacent gingival recessions (MAGR). The primary objectives of the study were to evaluate mean and complete roots coverage. Additionally, the secondary objective was to evaluate and compare the clinical effectiveness of PADM and SCTG for the treatment of MAGR defects applying MCAT.

Detailed Summary:

Treatment of multiple adjacent gingival recessions (MAGR) still presents a challenge for the clinician. the management of soft tissues becomes more complicated and the wound healing may be compromised by a variety of factors.

According to the available medical databases, predictable root coverage is possible for multiple-tooth recession defects using subepithelial connective tissue graft (SCTG) procedures. However, alternative materials to SCTG are supported by evidence of varying strength, with the need for additional research to confirm their performance and success rate. Because of that, the aim of this study was to assess the clinical efficacy of the acellular porcine derived collagen matrix (PADM) in comparison with connective tissue graft (SCTG ) in the treatment of multiple adjacent gingival recessions (MAGR).

This study is a randomised controlled clinical trial of 12 months duration. Sixteen patients with a total of 81 MAGR Miller's Class I or II were enrolled in this study. Recessions were randomly treated with PADM and SCTG, combined with a modified coronally advanced tunnel technique (MCAT). Several parameters, such as gingival recession coverage (RC), keratinized tissue width (KTW), keratinized tissue thickness (KTT) and clinical attachment level (CAL) were recorded at baseline and one year postoperatively. Healing index (HI) was registered on 1st, 2nd, and 3rd-week post-surgery in order to estimate healing events.


Sponsor: Botiss Medical AG

Current Primary Outcome:

  • mean root coverage (MRC) [ Time Frame: 12 months ]
    The percentage of covered recession area (MRC)
  • complete root coverage (CRC) [ Time Frame: 12 months ]
    The percentage rate of patients with complete coverage of all recessions (CRC)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • gingival recession (GR) [ Time Frame: 12 months ]
    Distance measured at the mid-buccal aspect of the tooth from the cemento-enamel junction to the most apical point of the gingival margin
  • gingival recession width (GRW) [ Time Frame: 12 months ]
    measured at mesio-distal direction at the level of cemento-enamel junction
  • Keratinized tissue wide (KTW) [ Time Frame: 12 months ]
    Distance from the mucogingival junction to the gingival margin
  • Gingival thickness (GT) [ Time Frame: 12 months ]
    Measured at the mid- buccal aspect of treated tooth on the long axis
  • Clinical attachment level (CAL), [ Time Frame: 12 months ]
    Distance from the cemento enamel junction to the deepest point of the gingival sulcus


Original Secondary Outcome: Same as current

Information By: Botiss Medical AG

Dates:
Date Received: May 21, 2017
Date Started: December 2014
Date Completion:
Last Updated: May 21, 2017
Last Verified: December 2016