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Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Gingival Recessions

Primary Purpose

Gingival Recession

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Semilunar coronally positioned flap

Enamel matrix derivative (Emdogain)

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Gingival Recession, Semilunar flap, Enamel matrix derivative, Periodontal regeneration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sites / Locations

Piracicaba Dental School, State University of Campinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SCPF + EMD (TEST)

SCPF (CONTROL)

Arm Description

Semilunar coronally positioned flap with Enamel matrix derivative (Emdogain)

Semilunar coronally positioned flap alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complete root coverage

Assessed as percentage of sites with complete root coverage

Full Information

NCT ID

NCT02459704

First Posted

May 25, 2015

Last Updated

October 6, 2015

Sponsor

University of Campinas, Brazil

1. Study Identification

Unique Protocol Identification Number

NCT02459704

Brief Title

Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Gingival Recessions

Official Title

Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Miller Class I Gingival Recessions: Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Campinas, Brazil

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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 selected, randomized and allocated in two groups: test group (SCPF + EMD) and control group (SCPF). The subjects will should present buccal Miller class I gingival recessions with height greater than or equal to 2.0 mm and less than to 4.0 mm in maxillary canines or premolars. Clinical parameters will be evaluated: gingival recession height (GRH), gingival recession width(GRW), clinical attachment level (CAL), probing depth (PD), height (HKT) and thickness (TKT) of keratinized tissue and papillas height (HP) and width(LP), as well as plaque and gingival index. These data will be collected at baseline and 180 days after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

Keywords

Gingival Recession, Semilunar flap, Enamel matrix derivative, Periodontal regeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SCPF + EMD (TEST)

Arm Type

Experimental

Arm Description

Semilunar coronally positioned flap with Enamel matrix derivative (Emdogain)

Arm Title

SCPF (CONTROL)

Arm Type

Active Comparator

Arm Description

Semilunar coronally positioned flap alone

Intervention Type

Procedure

Intervention Name(s)

Semilunar coronally positioned flap

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Enamel matrix derivative (Emdogain)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline, 12 months

Secondary Outcome Measure Information:

Title

Complete root coverage

Description

Assessed as percentage of sites with complete root coverage

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enilson A Sallum, PhD

Organizational Affiliation

University of Campinas, Brazil

Official's Role

Principal Investigator

Facility Information:

Facility Name

Piracicaba Dental School, State University of Campinas

City

Piracicaba

State/Province

São Paulo

ZIP/Postal Code

13414-903

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

29948276

Citation

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. Erratum In: Psychopharmacology (Berl). 2021 Jan;238(1):323.

Results Reference

derived

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Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Gingival Recessions

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