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

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456337
• Other study ID #: 067/2013
• Secondary ID: 2013/19473-6
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2015
• Last updated: October 25, 2016
• Start date: July 2014
• Est. completion date: October 2016

Study information

• Verified date: December 2015
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Device:
• Mucograft
Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.
• Emdogain
Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.

Procedure:
• Coronally Advanced flap
Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School, State University of Campinas	Piracicaba	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Keratinized tissue thickness	Measured at a midpoint between gingival margin and mucogingival junction using a endodontic spreader pierced perpendicular and through the soft tissue	6 months	No
Primary	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	No
Secondary	Complete root coverage	Assessed as percentage of sites with complete root coverage	6 months	No