NCT02459704

Brief Summary

The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients will receive EMD associated to SCPF, while the other half, will receive SCPF alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 8, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

May 25, 2015

Last Update Submit

October 6, 2015

Conditions

Gingival Recession

Keywords

Gingival RecessionSemilunar flapEnamel matrix derivativePeriodontal regeneration

Outcome Measures

Primary Outcomes (1)

  • Change in Recession Reduction as measured by difference between gingival recession depth

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

    Baseline, 12 months

Secondary Outcomes (1)

  • Complete root coverage

    12 months

Study Arms (2)

SCPF + EMD (TEST)

EXPERIMENTAL

Semilunar coronally positioned flap with Enamel matrix derivative (Emdogain)

Procedure: Semilunar coronally positioned flapDevice: Enamel matrix derivative (Emdogain)

SCPF (CONTROL)

ACTIVE COMPARATOR

Semilunar coronally positioned flap alone

Procedure: Semilunar coronally positioned flap

Interventions

Semilunar coronally positioned flapPROCEDURE

Semilunar coronally positioned flap with enamel matrix derivative (Emdogain) or alone.

SCPF (CONTROL)SCPF + EMD (TEST)
Enamel matrix derivative (Emdogain)DEVICE

Enamel matrix derivative associated to semilunar coronally positioned flap (SCPF + EMD - test group)

SCPF + EMD (TEST)

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 Miller Class I gingival recession ≥ 2 mm or ≤ 4mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ);
  • Height of keratinized tissue ≥ 2 mm;
  • 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)

  • Franca-Grohmann IL, Sangiorgio JPM, Bueno MR, Casarin RCV, Silverio KG, Nociti FH Jr, Casati MZ, Sallum EA. Does enamel matrix derivative application improve clinical outcomes after semilunar flap surgery? A randomized clinical trial. Clin Oral Investig. 2019 Feb;23(2):879-887. doi: 10.1007/s00784-018-2506-y. Epub 2018 Jun 12.

    PMID: 29948276DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Enilson A Sallum, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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

June 2, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

October 8, 2015

Record last verified: 2015-05

Locations

BR(1)