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

Recession, Gingival Clinical Trial

— NPDMMAGR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163654
• Other study ID #: 36/24
• Status: Completed
• Phase: N/A
• First received: May 21, 2017
• Last updated: May 25, 2017
• Start date: December 2014
• Est. completion date: September 2016

Study information

• Verified date: May 2017
• Source: Botiss Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Recession, Gingival

Intervention

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.
• 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.

Locations

Country	Name	City	State
Serbia	Department of Periodontal and Oral Mucosa Diseases	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Botiss Medical AG

Country where clinical trial is conducted

Serbia, 

References & 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 . — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Probing depth (PD)	Distance from the gingival margin to the bottom of the sulcus	12 months
Primary	mean root coverage (MRC)	The percentage of covered recession area (MRC)	12 months
Primary	complete root coverage (CRC)	The percentage rate of patients with complete coverage of all recessions (CRC)	12 months
Secondary	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
Secondary	gingival recession width (GRW)	measured at mesio-distal direction at the level of cemento-enamel junction	12 months
Secondary	Keratinized tissue wide (KTW)	Distance from the mucogingival junction to the gingival margin	12 months
Secondary	Gingival thickness (GT)	Measured at the mid- buccal aspect of treated tooth on the long axis	12 months
Secondary	Clinical attachment level (CAL),	Distance from the cemento enamel junction to the deepest point of the gingival sulcus	12 months