AzTrials
AzTrials

Gingival RecessionPhase 43DMUCONCT02818855

Treatment of Multiple Gingival Recessions

A Phase 4 study testing Coronally advanced flap (CAF), Collagen Matrix and Subepithelial connective tissue graft in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.

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

Gingival recession (GR) is frequently associated with deterioration in dental esthetics and dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use of subepithelial connective tissue… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
Coronally advanced flap (CAF), Collagen Matrix and Subepithelial connective tissue graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteBrazil
Study dates
Mar 2014to Apr 2016
Phase
Phase 4
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The patients will be included in the study if they fulfill the following inclusion criteria:
  • a clinical diagnosis of multiple-recession type defects at maxillary canines and premolars with at least one GR ≥ 3mm in depth;
  • areas of Miller's Class I or II GR;
  • teeth without root abrasions or caries.

Who cannot join

  • The exclusion criteria used will be as follows:
  • patients allergic to collagen
  • a history of smoking (within the previous 6 months)
  • pregnancy or lactation
  • a history of destructive periodontal disease or the formation of recurrent abscesses
  • root caries at the site of recession
Show all 16Show fewer
  • previous surgical root coverage procedures
  • systemic healing disorders (for example, acquired immunodeficiency syndrome [AIDS], diabetes mellitus or risk factors evaluated by a medical doctor)
  • periodontal disease, or poor plaque control (full mouth plaque index > 20%).
  • The exclusion criteria for teeth will be:
  • noncarious cervical lesions (erosion, abfraction etc.)
  • any type of previous cervical restoration
  • extrusion
  • giroversion
  • mobility
  • a prominent root surface.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • University of São Paulo

    São Paulo, 05508-000

Other trials in Brazil

About this study

Official title: Treatment of Multiple Gingival Recessions With Collagen Matrix Versus Subepithelial Connective Tissue Graft: A Non-inferiority Randomized Clinical Trial

Gingival recession (GR) is frequently associated with deterioration in dental esthetics and dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced flaps (CAF) appears to be more predictable, and may be considered the gold standard procedure. However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs because of the need for a donor surgical area, which may increase the risk of surgical complications like bleeding, as well as increases post-operative discomfort and the period of the surgical procedure. Another biomaterial, a new collagen matrix (CM) has been used as a substitute for the SCTG. The use of CM was associated with a significant reduction in post-operative morbidity, less post-operative pain and discomfort in the patient, and more esthetic satisfaction.

Being tested
Coronally advanced flap (CAF), Collagen Matrix, Subepithelial connective tissue graft
Keywords
Root coverage, Gingival recession, Plastic surgery, Connective tissue graft, Mucograft
Medical subject headings
Gingival Recession

What participants receive

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

  • Coronally advanced flap (CAF)Procedure or surgery

    Also called Subepithelial conjunctive tissue grafts, Coronally advanced flaps, Coronally advanced flaps associated with collagen matrix

    The test group will be treated by means of the association of Collagen Matrix + Coronally Advanced Flap. As treatment, the control group will receive the association of a subepithelial Conjunctive Tissue Graft + Coronally Advanced Flap.

    The aim of both procedures will be to obtain root coverage. All these procedures will be performed in a standardized manner.

  • Collagen MatrixDrug

    Also called Mucograft

    A new collagen membrane

  • Subepithelial connective tissue graftProcedure or surgery

    Also called connective tissue graft

    Connective tissue graft

Study groups in NCT02818855
Study groupRoleWhat they receive
Collagen Matrix plus coronally advanced flap (CAF)ExperimentalA new collagen matrix (Mucograft) associated to coronally advanced flap
Receives: Procedure: Coronally advanced flap (CAF); Drug: Collagen Matrix
Subepithelial connective tissue graft plus CAFActive comparatorSubepithelial connective tissue graft associated to coronally advanced flap
Receives: Procedure: Coronally advanced flap (CAF); Procedure: Subepithelial connective tissue graft

What is being measured

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

  1. Percentage of root coverage (RC)

    The primary clinical outcome will be percentage of root coverage (RC) at 12 months

    Measured: 12-months

Secondary outcomes (7)

  1. Reductions in recession depth (RRD)

    Measured from the cementum-enamel junction (CEJ) up to the highest point of the gingival margin

    Measured: At the baseline, 3-month, 6-month and 12-months

  2. Complete root coverage of the gingival recessions (CRC)

    Measured: At the baseline, 3-month, 6-month and 12-months

  3. Recession width (RW) at the cemento-enamel junction

    Measured: At the baseline, 3-month, 6-month and 12-months

  4. Relative clinical attachment level (RCAL)

    Measured from a fixed point (stent) prepared on the acrylic guide up to the base of the gingival sulcus.

    Measured: At the baseline, 3-month, 6-month and 12-months

  5. Probing depth (PD)

    Calculated as RCAL- PD;

    Measured: At the baseline, 3-month, 6-month and 12-months

  6. keratinized tissue width (KT)

    From the free gingival margin to the mucogingival junction.

    Measured: At the baseline, 3-month, 6-month and 12-months

  7. Gain in thickness of gingival tissue (GT)

    With an injection needle and a silicon marker, 2mm below the gingival margin.

    Measured: At the baseline, 3-month, 6-month and 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 posted30 Jun 2016 (estimated)
  2. Study startMar 2014
  3. Primary completionOct 2015
  4. Study completionApr 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02818855
Sponsor's protocol ID
3DMUCO
Acronym
3DMUCO
Status last verified
Jan 2018
First submitted
20 Aug 2013
Last updated
5 Feb 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. Xenogeneic collagen matrix with coronally advanced flap compared to connective tissue with coronally advanced flap for the treatment of dehiscence-type recession defects. J Periodontol. 2010 Aug;81(8):1108-17. doi: 10.1902/jop.2010.090698.

    PubMed 20350159

  • Sanz M, Lorenzo R, Aranda JJ, Martin C, Orsini M. Clinical evaluation of a new collagen matrix (Mucograft prototype) to enhance the width of keratinized tissue in patients with fixed prosthetic restorations: a randomized prospective clinical trial. J Clin Periodontol. 2009 Oct;36(10):868-76. doi: 10.1111/j.1600-051X.2009.01460.x. Epub 2009 Aug 12.

    PubMed 19678861

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Coronally advanced flap (CAF), Collagen Matrix and Subepithelial connective tissue graft in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.

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 16 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 5 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 Brazil. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Percentage of root coverage (RC) (time frame: 12-months). 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 NCT02818855, which also lists 3 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 5 Feb 2018.

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