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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Recession, Gingival

Intervention / Treatment
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* Procedure: Surgery 1
* Procedure: Surgery 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br>Surgery 1: The tunnel technique for covering multiple gingival recessions. Graft: porcine-derived acellular dermal collagen matrix (PADM, mucoderm® ). | Procedure: Surgery 1<br>* 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.<br>|
| Active Comparator: Control group<br>Surgery 2: The tunnel technique for covering multiple gingival recessions. Graft: connective tissue graft | Procedure: Surgery 2<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple gingival recessions, collagen matrix, connective tissue graft, tunnel technique