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CompletedNCT03163654NPDMMAGRUpdated May 30, 2017

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

An interventional study of Surgery 1 and Surgery 2 in Recession, Gingival, sponsored by Botiss Medical AG. Completed at 1 site in Serbia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by Botiss Medical AG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Recession, Gingival

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Keywords

  • multiple gingival recessions
  • collagen matrix
  • connective tissue graft
  • tunnel technique
03

In context

Gingival Recession

413 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.

This study's enrollment of 16 is below the median of 30 across 379 interventional studies indexed under Gingival Recession.

Browse Gingival Recession studies →

Lead sponsor

Botiss Medical AG is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    Experimental group

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

    Procedure: Surgery 1

  • Active comparator
    Control group

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

    Procedure: Surgery 2

Interventions

  • ProcedureSurgery 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.

  • ProcedureSurgery 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.

06

What researchers measure

Primary outcomes

  1. mean root coverage (MRC)

    The percentage of covered recession area (MRC)

    Time frame: 12 months

  2. complete root coverage (CRC)

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

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 12 months

  2. gingival recession width (GRW)

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

    Time frame: 12 months

  3. Keratinized tissue wide (KTW)

    Distance from the mucogingival junction to the gingival margin

    Time frame: 12 months

  4. Gingival thickness (GT)

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

    Time frame: 12 months

  5. Clinical attachment level (CAL),

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

    Time frame: 12 months

Other outcomes

  1. Probing depth (PD)

    Distance from the gingival margin to the bottom of the sulcus

    Time frame: 12 months

07

Study locations

1 site
  • Department of Periodontal and Oral Mucosa Diseases
    Belgrade, 11000, Serbia
08

References and documents

Publications

  • 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. PubMed 19186964 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2014, a primary completion of Apr 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2017
First posted
May 23, 2017
Start
Dec 2014
Primary completionActual
Apr 2016
CompletionActual
Sep 2016
Last update
May 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03163654
Lead sponsor
Botiss Medical AG
Responsible party
Dragana Rakasevic (Doctor of dental medicine, University of Belgrade) — Principal investigator
First posted
May 23, 2017
Start date
Dec 2014
Primary completion
Apr 2016
Completion
Sep 2016
Last update
May 30, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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