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Gingival RecessionNCT02986191

The Use of Mucograft® to Treat Gingival Recession

A study testing Mucograft and Connective Tissue Graft in people with Gingival Recession, run by Damascus University at 1 site in Syria.

Completed

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

Official record
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Trial summary

Twenty patients with gingival recession will be enrolled in this trial. Gingival recession will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while on the opposite side a connective tissue graft (from the palate) will be applied with a CAF. Read more about this study

Who is it for?
Ages 20 to 45 years
Conditions the study is for
Gingival Recession
What is being tested?
Mucograft and Connective Tissue Graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSyria
Study dates
Aug 2016to 20 Dec 2017
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 20 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Presence of Type I or II (Miller Classification) of gingival recession

Who cannot join

  • Smoking
  • Pregnancy or lactating
  • Presence of any systematic diseases can affect the periodontal surgery.
  • Subjects with significant moderate to severe periodontal disease.
  • Patients under orthodontic treatment
  • Presence of restorative materials (e.g. crown)
Show all 9Show fewer
  • Effectiveness of frenum
  • Subjects have failed to maintain good plaque control.
  • Subjects having previous surgical treatment for covering the recession in the chosen area.

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Department of Periodontics, University of Damascus Dental School

    Damascus, DM20AM18

Other trials in Syria

About this study

Official title: Clinical Applications of 3D Collagen Matrix (Mucograft®) in the Management of Gingival Recession: a Randomized Controlled Trial

Twenty patients with gingival recession will be enrolled in this trial. Gingival recession will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.

Patients will be followed for 3 and 6 months by measuring the clinical indexes and statistical analyses will be performed to compare the results and to assess the success of Mucograft®.

Read the detailed description

Many surgical techniques have used to treat gingival recession such aas repositioned flaps, autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft® (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue regeneration and considered the ideal solution to autogenous soft tissue grafts and it provides an ideal matrix for blood vessel and soft tissue ingrowth.

Being tested
Mucograft, Connective Tissue Graft
Keywords
gingival graft, free gingival graft, coronally advanced flap, reduced keratinized gingiva
Medical subject headings
Gingival Recession

What participants receive

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

  • MucograftProcedure or surgery

    This method of grafting will be used to treat the gingival recession using coronally advanced flaps.

  • Connective Tissue GraftProcedure or surgery

    This will be used in the traditional manner to correct gingival recession

Study groups in NCT02986191
Study groupRoleWhat they receive
MucograftExperimentalOne side of the mouth will be subjected to Mucograft in this split-mouth study design.
Receives: Procedure: Mucograft
Connective tissue graftActive comparatorThe opposite side of the mouth will be subjected to a connective tissue graft.
Receives: Procedure: Connective Tissue Graft

What is being measured

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

  1. Change in the Clinical Attachment Level Index

    Clinical Attachment Level is dependent on measuring the pocket depth as well as the amount of gingival recession using specific tools. The measurement is going to be recorded in millimeters.

    Measured: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

Secondary outcomes (8)

  1. Change in Probing Depth

    Probing depth is going to be measuring using a specific tool (UNC-15 probe).

    Measured: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

  2. Change in Gingival Recession

    Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.

    Measured: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

  3. Change in Gingival Biotype

    Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin).

    Measured: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

  4. Change in Root Coverage Index

    The amount of root exposure will be measured and compared to the total length of the root

    Measured: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

  5. Change in Resistance to Muscular Pull

    The cheeks or lips are going to be retracted by hand or by a mirror in order to see the movement of the free gingival tissues. The movement will be esitmated in millimeters.

    Measured: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

  6. Change in Color Match Index

    Measured: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

  7. Shrinkage index at three months

    Measured: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively.

  8. Shrinkage index at six months

    Measured: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively.

Timeline

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

  1. First posted8 Dec 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionApr 2017
  4. Study completion20 Dec 2017

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
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02986191
Sponsor's protocol ID
UDDS-Perio-01-2016
Status last verified
Feb 2018
First submitted
29 Nov 2016
Last updated
6 Feb 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Herford AS, Akin L, Cicciu M, Maiorana C, Boyne PJ. Use of a porcine collagen matrix as an alternative to autogenous tissue for grafting oral soft tissue defects. J Oral Maxillofac Surg. 2010 Jul;68(7):1463-70. doi: 10.1016/j.joms.2010.02.054. Epub 2010 Apr 22.

    PubMed 20417009

  • Nevins M, Nevins ML, Kim SW, Schupbach P, Kim DM. The use of mucograft collagen matrix to augment the zone of keratinized tissue around teeth: a pilot study. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):367-73.

    PubMed 21837302

  • Rocchietta I, Schupbach P, Ghezzi C, Maschera E, Simion M. Soft tissue integration of a porcine collagen membrane: an experimental study in pigs. Int J Periodontics Restorative Dent. 2012 Feb;32(1):e34-40.

    PubMed 22254233

  • Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.

    PubMed 21721988

  • Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.

    PubMed 23050490

  • McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5.

    PubMed 24597764

  • McGuire MK, Scheyer ET. Long-Term Results Comparing Xenogeneic Collagen Matrix and Autogenous Connective Tissue Grafts With Coronally Advanced Flaps for Treatment of Dehiscence-Type Recession Defects. J Periodontol. 2016 Mar;87(3):221-7. doi: 10.1902/jop.2015.150386. Epub 2015 Oct 15.

    PubMed 26469812

Questions about this trial

What is this clinical trial studying?

A study testing Mucograft and Connective Tissue Graft in people with Gingival Recession, run by Damascus University at 1 site in Syria.

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 1 inclusion and 9 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 6 Feb 2018. 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 Syria. 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?

Change in the Clinical Attachment Level Index (time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively). 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 NCT02986191, which also lists 7 linked publications.

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 6 Feb 2018.

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