NCT02456337

Brief Summary

The purpose of this study is to evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 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

Study Start

First participant enrolled

July 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

December 1, 2015

Enrollment Period

2.2 years

First QC Date

May 25, 2015

Last Update Submit

October 25, 2016

Conditions

Gingival Recession

Keywords

Gingival RecessionCoronally advanced flapPeriodontal regeneration

Outcome Measures

Primary Outcomes (1)

  • Recession Reduction

    Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.

    6 months

Secondary Outcomes (1)

  • Complete root coverage

    6 months

Other Outcomes (1)

  • Keratinized tissue thickness

    6 months

Study Arms (4)

CAF+MC+EMD

EXPERIMENTAL

Coronally Advanced Flap with Mucograft and Emdogain

Device: MucograftDevice: EmdogainProcedure: Coronally Advanced flap

CAF+MC

ACTIVE COMPARATOR

Coronally Advanced Flap with Mucograft

Device: MucograftProcedure: Coronally Advanced flap

CAF+EMD

ACTIVE COMPARATOR

Coronally Advanced Flap with Emdogain

Device: EmdogainProcedure: Coronally Advanced flap

CAF

ACTIVE COMPARATOR

Coronally Advanced Flap alone

Procedure: Coronally Advanced flap

Interventions

MucograftDEVICE

Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.

CAF+MCCAF+MC+EMD
EmdogainDEVICE

Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.

CAF+EMDCAF+MC+EMD
Coronally Advanced flapPROCEDURE

Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.

CAFCAF+EMDCAF+MCCAF+MC+EMD

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥ 18 years.
  • Presence of at least one Class I or II Miller gingival recession ≥ 2.5 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (\< 0.5 mm): A +(Pini-Prato et al. 2010).
  • Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
  • Full-mouth visible plaque index ≤ 20% (Ainamo \& Bay 1975).
  • Full-mouth sulcus bleeding index ≤ 20% (Mühlemann \& Son 1971).

You may not qualify if:

  • Smoking.
  • Pregnancy.
  • Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
  • Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
  • Previous periodontal surgery in the area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

Related Publications (1)

  • Sangiorgio JPM, Neves FLDS, Rocha Dos Santos M, Franca-Grohmann IL, Casarin RCV, Casati MZ, Santamaria MP, Sallum EA. Xenogenous Collagen Matrix and/or Enamel Matrix Derivative for Treatment of Localized Gingival Recessions: A Randomized Clinical Trial. Part I: Clinical Outcomes. J Periodontol. 2017 Dec;88(12):1309-1318. doi: 10.1902/jop.2017.170126. Epub 2017 Jul 28.

    PMID: 28753100DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Enilson A Sallum, PhD

    University of Campinas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor. Department of Periodontics. Piracicaba Dental School. State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil.

Study Record Dates

First Submitted

May 25, 2015

First Posted

May 28, 2015

Study Start

July 1, 2014

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

October 27, 2016

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)