Novel Porcine Dermal Matrix in the Treatment of Multiple Adjacent Gingival Recessions (NPDMMAGR)

B

Botiss Medical AG

Status

Completed

Conditions

Recession, Gingival

Treatments

Procedure: Surgery 2
Procedure: Surgery 1

Study type

Interventional

Funder types

Other

Identifiers

NCT03163654
36/24

Details and patient eligibility

About

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 modified coronally advanced tunnel technique (MCAT).

Full description

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.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • At least two multiple maxillaries or mandibular Miller's Class I and II recession, more than >2mm defects together with similar contralateral lesions
  • No active periodontal disease with PD>4mm
  • Absence of the radiographic signs of periapical infection on the teeth to be treated or on the adjacent teeth
  • A full mouth plaque index <20% and gingival index < 1

Exclusion criteria

  • The inflammatory periodontal disease/ Untreated periodontal conditions
  • Previous surgical attempt to correct gingival recession
  • Pregnant or breastfeeding women
  • Systemic diseases with compromised healing potential or infectious diseases

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

16 participants in 2 patient groups

Experimental group
Active Comparator group
Description:
Surgery 1: The tunnel technique for covering multiple gingival recessions. Graft: porcine-derived acellular dermal collagen matrix (PADM, mucoderm® ).
Treatment:
Procedure: Surgery 1
Control group
Active Comparator group
Description:
Surgery 2: The tunnel technique for covering multiple gingival recessions. Graft: connective tissue graft
Treatment:
Procedure: Surgery 2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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