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Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage

Primary Purpose

Gingival Recession

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Mucograft

Emdogain

Coronally Advanced flap

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Gingival Recession, Coronally advanced flap, 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 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).

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 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

CAF+MC+EMD

CAF+MC

CAF+EMD

CAF

Arm Description

Coronally Advanced Flap with Mucograft and Emdogain

Coronally Advanced Flap with Mucograft

Coronally Advanced Flap with Emdogain

Coronally Advanced Flap alone

Outcomes

Primary Outcome Measures

Recession Reduction

Measured as a difference between gingival margin 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

NCT02456337

First Posted

May 25, 2015

Last Updated

October 25, 2016

Sponsor

University of Campinas, Brazil

Collaborators

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02456337

Brief Title

Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage

Official Title

Xenogenous Collagen Matrix Graft Associated or Not With Enamel Matrix Derivative Proteins in the Treatment of Gingival Recession Class I and II of Miller: Randomized Controlled Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Campinas, Brazil

Collaborators

University of Sao Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Gingival Recession

Keywords

Gingival Recession, Coronally advanced flap, Periodontal regeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CAF+MC+EMD

Arm Type

Experimental

Arm Description

Coronally Advanced Flap with Mucograft and Emdogain

Arm Title

CAF+MC

Arm Type

Active Comparator

Arm Description

Coronally Advanced Flap with Mucograft

Arm Title

CAF+EMD

Arm Type

Active Comparator

Arm Description

Coronally Advanced Flap with Emdogain

Arm Title

CAF

Arm Type

Active Comparator

Arm Description

Coronally Advanced Flap alone

Intervention Type

Device

Intervention Name(s)

Mucograft

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Emdogain

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Coronally Advanced flap

Intervention Description

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

Primary Outcome Measure Information:

Title

Recession Reduction

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Complete root coverage

Description

Assessed as percentage of sites with complete root coverage

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Keratinized tissue thickness

Description

Measured at a midpoint between gingival margin and mucogingival junction using a endodontic spreader pierced perpendicular and through the soft tissue

Time Frame

6 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 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). 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

Official's Role

Study Chair

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

Plan to Share IPD

Citations:

PubMed Identifier

28753100

Citation

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.

Results Reference

derived

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Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage

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