NCT02818855

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

August 20, 2013

Last Update Submit

January 31, 2018

Conditions

Gingival Recession

Keywords

Root coverageGingival recessionPlastic surgeryConnective tissue graftMucograft

Outcome Measures

Primary Outcomes (1)

  • Percentage of root coverage (RC)

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

    12-months

Secondary Outcomes (7)

  • Reductions in recession depth (RRD)

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

  • Complete root coverage of the gingival recessions (CRC)

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

  • Recession width (RW) at the cemento-enamel junction

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

  • Relative clinical attachment level (RCAL)

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

  • Probing depth (PD)

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

  • +2 more secondary outcomes

Other Outcomes (3)

  • Subject esthetic satisfaction by participants

    1, 3, 6 months and after 12 months

  • Subjective symptoms of pain and discomfort by participants

    At 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.

  • Esthetic questionnaire by experienced periodontist

    1, 2, 3-week, 1-month, 3-month, 6-month and 12-months after surgery

Study Arms (2)

Collagen Matrix plus coronally advanced flap (CAF)

EXPERIMENTAL

A new collagen matrix (Mucograft) associated to coronally advanced flap

Procedure: Coronally advanced flap (CAF)Drug: Collagen Matrix

Subepithelial connective tissue graft plus CAF

ACTIVE COMPARATOR

Subepithelial connective tissue graft associated to coronally advanced flap

Procedure: Coronally advanced flap (CAF)Procedure: Subepithelial connective tissue graft

Interventions

Coronally advanced flap (CAF)PROCEDURE

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.

Also known as: Subepithelial conjunctive tissue grafts, Coronally advanced flaps, Coronally advanced flaps associated with collagen matrix
Collagen Matrix plus coronally advanced flap (CAF)Subepithelial connective tissue graft plus CAF
Collagen MatrixDRUG

A new collagen membrane

Also known as: Mucograft
Collagen Matrix plus coronally advanced flap (CAF)
Subepithelial connective tissue graftPROCEDURE

Connective tissue graft

Also known as: connective tissue graft
Subepithelial connective tissue graft plus CAF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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%).
  • noncarious cervical lesions (erosion, abfraction etc.)
  • any type of previous cervical restoration
  • extrusion
  • giroversion
  • mobility
  • a prominent root surface.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

São Paulo, 05508-000, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 23050490RESULT

  • 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.

    PMID: 20350159RESULT

  • 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.

    PMID: 19678861RESULT

MeSH Terms

Conditions

Gingival Recession

Interventions

Mucograft

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Giuseppe Romito, PhD

    University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairperson, Department of Periodontics

Study Record Dates

First Submitted

August 20, 2013

First Posted

June 30, 2016

Study Start

March 1, 2014

Primary Completion

October 1, 2015

Study Completion

April 1, 2016

Last Updated

February 5, 2018

Record last verified: 2018-01

Locations

BR(1)