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

Primary Purpose

Recession, Gingival

Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Surgery 1
Surgery 2
Sponsored by
Botiss Medical AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recession, Gingival focused on measuring multiple gingival recessions, collagen matrix, connective tissue graft, tunnel technique

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Periodontal and Oral Mucosa Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

mean root coverage (MRC)
The percentage of covered recession area (MRC)
complete root coverage (CRC)
The percentage rate of patients with complete coverage of all recessions (CRC)

Secondary Outcome Measures

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

Full Information

First Posted
May 21, 2017
Last Updated
May 25, 2017
Sponsor
Botiss Medical AG
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1. Study Identification

Unique Protocol Identification Number
NCT03163654
Brief Title
Novel Porcine Dermal Matrix in the Treatment of Multiple Adjacent Gingival Recessions
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Botiss Medical AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recession, Gingival
Keywords
multiple gingival recessions, collagen matrix, connective tissue graft, tunnel technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Single Blind
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
Surgery 1: The tunnel technique for covering multiple gingival recessions. Graft: porcine-derived acellular dermal collagen matrix (PADM, mucoderm® ).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Surgery 2: The tunnel technique for covering multiple gingival recessions. Graft: connective tissue graft
Intervention Type
Procedure
Intervention Name(s)
Surgery 1
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgery 2
Intervention Description
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 Outcome Measure Information:
Title
mean root coverage (MRC)
Description
The percentage of covered recession area (MRC)
Time Frame
12 months
Title
complete root coverage (CRC)
Description
The percentage rate of patients with complete coverage of all recessions (CRC)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
gingival recession (GR)
Description
Distance measured at the mid-buccal aspect of the tooth from the cemento-enamel junction to the most apical point of the gingival margin
Time Frame
12 months
Title
gingival recession width (GRW)
Description
measured at mesio-distal direction at the level of cemento-enamel junction
Time Frame
12 months
Title
Keratinized tissue wide (KTW)
Description
Distance from the mucogingival junction to the gingival margin
Time Frame
12 months
Title
Gingival thickness (GT)
Description
Measured at the mid- buccal aspect of treated tooth on the long axis
Time Frame
12 months
Title
Clinical attachment level (CAL),
Description
Distance from the cemento enamel junction to the deepest point of the gingival sulcus
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Probing depth (PD)
Description
Distance from the gingival margin to the bottom of the sulcus
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Periodontal and Oral Mucosa Diseases
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19186964
Citation
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.
Results Reference
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Novel Porcine Dermal Matrix in the Treatment of Multiple Adjacent Gingival Recessions

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