NCT03207984

Brief Summary

Subepithelial connective tissue graft (SCTG) is considered the gold standard for root coverage treatment. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of MC are very promising, both for root coverage as well as for the gain of keratinized tissue. The present study consists of a parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (upper central incisors, Lateral and canine).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

March 8, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

3.5 years

First QC Date

June 30, 2017

Last Update Submit

February 27, 2023

Conditions

Gingival Recession, Generalized

Keywords

Gingival RecessionCollagen MatrixPeriodontics

Outcome Measures

Primary Outcomes (1)

  • Gingival recession depth (GRD)

    Distance in millimeters from ECJ to gingival margin at three points (mesial, center and distal); Distance from cemento-enamel junction to gingival margin = 0 mm

    one year

Secondary Outcomes (2)

  • Keratinized mucosa width

    year

  • Dentin hypersensitivity

    year

Other Outcomes (4)

  • Complete root coverage

    year

  • Probing Depth (PD)

    year

  • Clinical attachment level loss (CAL)

    year

  • +1 more other outcomes

Study Arms (2)

Control SCTG

ACTIVE COMPARATOR

Root coverage surgery with subepithelial connective tissue graft to an extensive treat multiple gingival recessions in aesthetic areas

Procedure: Root coverage surgery

Test CM

EXPERIMENTAL

Root coverage surgery with Mucograft® collagen matrix to treat an extensive multiple gingival recessions in aesthetic areas

Procedure: Root coverage surgery

Interventions

Root coverage surgeryPROCEDURE

Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM

Control SCTGTest CM

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of multiple gingival recessions ≥ 2 mm, only in aesthetic areas (upper central and lateral incisive, and canine);
  • Miller class I and II gingival recession areas
  • Non-abrasive, erosive, or carious root surfaces
  • Unrotated, non-extruded, and non-movable teeth
  • Systemically healthy patients without contraindication to periodontal surgical procedures

You may not qualify if:

  • Smokers
  • Pregnant women and infants
  • Patients with a history of periodontal disease or recurrent abscess formation
  • Patients previously submitted to surgical procedures for root coverage
  • Patients taking anti-convulsant drugs
  • Antihypertensives, contraceptives or immunosuppressors
  • Patients with low oral hygiene (plaque and bleeding index over 20%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raphaella C Michel

Bauru, São Paulo, 17012-901, Brazil

Location

Related Publications (2)

  • 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: 20350159BACKGROUND

  • 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.

    PMID: 21721988BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Raphaella C Michel, PhD

    University of São Paulo, Bauru School of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 5, 2017

Study Start

March 8, 2017

Primary Completion

September 20, 2020

Study Completion

December 1, 2021

Last Updated

March 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)