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

NCT03163654 | Completed DMC

• 1 other identifier: 36/24
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Recession, Gingival

Keywords

multiple gingival recessions; collagen matrix; connective tissue graft; tunnel technique

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• gingival recession (GR)

  12 months

• gingival recession width (GRW)

  12 months

• Keratinized tissue wide (KTW)

  12 months

• Gingival thickness (GT)

  12 months

• Clinical attachment level (CAL),

  12 months

Other Outcomes (1)

• Probing depth (PD)

  12 months

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Surgery 1: The tunnel technique for covering multiple gingival recessions. Graft: porcine-derived acellular dermal collagen matrix (PADM, mucoderm® ).

Procedure: Surgery 1

Control group

ACTIVE COMPARATOR

Surgery 2: The tunnel technique for covering multiple gingival recessions. Graft: connective tissue graft

Procedure: Surgery 2

Interventions

Surgery 1 PROCEDURE

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.

Experimental group

Surgery 2 PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Botiss Medical AG: lead

Study Sites (1)

Department of Periodontal and Oral Mucosa Diseases

Belgrade, 11000, Serbia

Location

Related Publications (1)

• 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.

  PMID: 19186964 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Single Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of dental medicine

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: May 23, 2017
• Study Start: December 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

SE (1)