Coronally Advanced Flap With or Without Porcine Collagen Matrix for Root Coverage

Gingival Recession Clinical Trial

Official title:

Phase IV Study of Coronally Advanced Flap With or Without Porcine Collagen Matrix for Treatment of Gingival Recession: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242500
• Other study ID #: 130/2010
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2014
• Last updated: December 26, 2015
• Start date: December 2010
• Est. completion date: October 2013

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 compare the clinical outcomes after coronally advanced flap technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of single gingival recessions. For this blinded randomized controlled clinical trial, 40 patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters evaluated will be probing depth, clinical attachment level, gingival recession height, height and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45 days, 2, 3 and 6 months after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Presence of at least one Class I or II Miller gingival recession = 2 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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Coronally Advanced Flap

Device:
• Mucograft

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Enilson Antonio Sallum	University of Bern

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