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

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

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).

Study Overview

• Status: Completed
• Conditions: Recession, Gingival
• Intervention / Treatment: Procedure: Surgery 1; Procedure: Surgery 2

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • Department of Periodontal and Oral Mucosa Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Experimental group; Surgery 1: The tunnel technique for covering multiple gingival recessions. Graft: porcine-derived acellular dermal collagen matrix (PADM, mucoderm® ).	Procedure: Surgery 1; Following local anaesthesia (Articaine hydrochloride 4% with 1:200,000 epinephrine injection) administration, sulcular incisions were made in the recession's areas of teeth without damaging interdental papilla. Mucoperiosteal (MP) dissections were made using the periostal elevator creating the deep pouch beyond the mucogingival junction so that the (MP) flap could be moved coronally without tension. Porcine-derived acellular dermal collagen matrix (PADM) was positioned at the level of a cemento-enamel junction (CEJ) and skin tight for teeth to avoid forming a blood clot. Separate single sutures per tooth with 5-0 resorbable suture were used to stabilise graft. The tunnel flap was positioned coronally above the CEJ to completely cover the graft and sutured with non-resorbable polypropylene suture.
ACTIVE_COMPARATOR: Control group; Surgery 2: The tunnel technique for covering multiple gingival recessions. Graft: connective tissue graft	Procedure: Surgery 2; Following local anaesthesia (Articaine hydrochloride 4% with 1:200,000 epinephrine injection) administration, sulcular incisions were made in the recession's areas of teeth without damaging interdental papilla. Mucoperiosteal (MP) dissections were made using the periostal elevator creating the deep pouch beyond the mucogingival junction so that the (MP) flap could be moved coronally without tension. Connective tissue graft was positioned at the level of a cemento-enamel junction (CEJ) and skin tight for teeth to avoid forming a blood clot. Separate single sutures per tooth with 5-0 resorbable suture were used to stabilise graft. The tunnel flap was positioned coronally above the CEJ to completely cover the graft and sutured with non-resorbable polypropylene suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean root coverage (MRC)	The percentage of covered recession area (MRC)	12 months
complete root coverage (CRC)	The percentage rate of patients with complete coverage of all recessions (CRC)	12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth (PD)	Distance from the gingival margin to the bottom of the sulcus	12 months

Collaborators and Investigators

• Sponsor: Botiss Medical AG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: May 21, 2017
• First Submitted That Met QC Criteria: May 21, 2017
• First Posted (ACTUAL): May 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: connective tissue graft; collagen matrix; tunnel technique; multiple gingival recessions
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 36/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No