AzTrials
AzTrials

Recession, GingivalNPDMMAGRNCT03163654

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

A study testing Surgery 1 and Surgery 2 in people with Recession, Gingival, run by Botiss Medical AG at 1 site in Serbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Recession, Gingival
What is being tested?
Surgery 1 and Surgery 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSerbia
Study dates
Dec 2014to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Serbia1 site

  • Department of Periodontal and Oral Mucosa Diseases

    Belgrade, 11000

Other trials in Serbia

About this study

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

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.

Being tested
Surgery 1, Surgery 2
Keywords
multiple gingival recessions, collagen matrix, connective tissue graft, tunnel technique
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgery 1Procedure or surgery

    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 2Procedure or surgery

    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.

Study groups in NCT03163654
Study groupRoleWhat they receive
Experimental groupActive comparatorSurgery 1: The tunnel technique for covering multiple gingival recessions. Graft: porcine-derived acellular dermal collagen matrix (PADM, mucoderm® ).
Receives: Procedure: Surgery 1
Control groupActive comparatorSurgery 2: The tunnel technique for covering multiple gingival recessions. Graft: connective tissue graft
Receives: Procedure: Surgery 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mean root coverage (MRC)

    The percentage of covered recession area (MRC)

    Measured: 12 months

  2. complete root coverage (CRC)

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

    Measured: 12 months

Secondary outcomes (5)

  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

    Measured: 12 months

  2. gingival recession width (GRW)

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

    Measured: 12 months

  3. Keratinized tissue wide (KTW)

    Distance from the mucogingival junction to the gingival margin

    Measured: 12 months

  4. Gingival thickness (GT)

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

    Measured: 12 months

  5. Clinical attachment level (CAL),

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2017
  2. Study startDec 2014
  3. Primary completionApr 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03163654
Sponsor's protocol ID
36/24
Acronym
NPDMMAGR
Status last verified
May 2017
First submitted
21 May 2017
Last updated
30 May 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing Surgery 1 and Surgery 2 in people with Recession, Gingival, run by Botiss Medical AG at 1 site in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean root coverage (MRC) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03163654, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in