Clinical trial NCT03163654: Novel Porcine Dermal Matrix in the Treatment of Multiple Adjacent Gingival Recessions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recession, Gingival
Keywords: multiple gingival recessions
collagen matrix
connective tissue graft
tunnel technique
Lead sponsor: Botiss Medical AG
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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 modified coronally advanced tunnel technique (MCAT).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: mean root coverage (MRC)
timeFrame: 12 months
measure: complete root coverage (CRC)
timeFrame: 12 months
Secondary outcomes:
measure: gingival recession (GR)
timeFrame: 12 months
measure: gingival recession width (GRW)
timeFrame: 12 months
measure: Keratinized tissue wide (KTW)
timeFrame: 12 months
measure: Gingival thickness (GT)
timeFrame: 12 months
measure: Clinical attachment level (CAL),
timeFrame: 12 months
Other outcomes:
measure: Probing depth (PD)
timeFrame: 12 months
Locations:
city: Belgrade
country: Serbia
facility: Department of Periodontal and Oral Mucosa Diseases
Study officials:
References:
citation: Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.