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

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Coronally Advanced Flap; Device: Mucograft

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Piracicaba, São Paulo, Brazil, 13414-903
      • Piracicaba Dental School, State University of Campinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coronally advanced flap + Mucograft; coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft	Procedure: Coronally Advanced Flap; Device: Mucograft; Other Names: Porcine collagen matrix for soft tissue regeneration
Other: Coronally advanced flap; Coronally advanced flap procedure alone	Procedure: Coronally Advanced Flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete root coverage	Assessed as percentage of sites with complete root coverage	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Enilson Antonio Sallum
• Collaborators: University of Bern

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: September 13, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 17, 2014

Study Record Updates

• Last Update Posted (Estimate): December 29, 2015
• Last Update Submitted That Met QC Criteria: December 26, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Treatment outcome; Root coverage; Gingival recession/surgery; Collagen/therapeutic use
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 130/2010