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NCT Number: NCT03163654

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

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).

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Key information

Conditions

Recession, Gingival Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontal and Oral Mucosa Diseases

Belgrade, 11000, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. mean root coverage (MRC)

    Time frame: 12 months

    The percentage of covered recession area (MRC)

  2. complete root coverage (CRC)

    Time frame: 12 months

    The percentage rate of patients with complete coverage of all recessions (CRC)

Secondary outcomes

  1. gingival recession (GR)

    Time frame: 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

  2. gingival recession width (GRW)

    Time frame: 12 months

    measured at mesio-distal direction at the level of cemento-enamel junction

  3. Keratinized tissue wide (KTW)

    Time frame: 12 months

    Distance from the mucogingival junction to the gingival margin

  4. Gingival thickness (GT)

    Time frame: 12 months

    Measured at the mid- buccal aspect of treated tooth on the long axis

  5. Clinical attachment level (CAL),

    Time frame: 12 months

    Distance from the cemento enamel junction to the deepest point of the gingival sulcus

Other outcomes

  1. Probing depth (PD)

    Time frame: 12 months

    Distance from the gingival margin to the bottom of the sulcus

Sponsors and collaborators

Lead sponsor

Botiss Medical AG

Other

Registry information

Official study 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

Acronym: NPDMMAGR

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 23, 2017
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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