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

Not Applicable

Completed

• Conditions: Recession, Gingival
• Interventions: Procedure: Surgery 2; Procedure: Surgery 1

• Registration Number: NCT03163654
• Lead Sponsor: Botiss Medical AG

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.

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2016-04
• Study Completion: 2016-09
• Status Verified: 2017-05
• Study First Submitted: 2017-05-21
• Study First Submitted QC: 2017-05-21
• Study First Posted: 2017-05-23
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
mean root coverage (MRC)	12 months	The percentage of covered recession area (MRC)
complete root coverage (CRC)	12 months	The percentage rate of patients with complete coverage of all recessions (CRC)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Periodontal and Oral Mucosa Diseases; 🇷🇸 Belgrade, Serbia