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

NCT02242500 | Completed Phase 4

• 1 other identifier: 130/2010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Recession

Keywords

Gingival recession/surgery; Collagen/therapeutic use; Root coverage; Treatment outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complete root coverage

  6 months

Other Outcomes (1)

• Keratinized tissue thickness

  6 months

Study Arms (2)

Coronally advanced flap + Mucograft

EXPERIMENTAL

coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft

Procedure: Coronally Advanced Flap; Device: Mucograft

Coronally advanced flap

OTHER

Coronally advanced flap procedure alone

Procedure: Coronally Advanced Flap

Interventions

Coronally Advanced Flap PROCEDURE

Coronally advanced flap; Coronally advanced flap + Mucograft

Mucograft DEVICE

Also known as: Porcine collagen matrix for soft tissue regeneration

Coronally advanced flap + Mucograft

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enilson Antonio Sallum: lead
• University of Bern: collaborator

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair of the Department of Prosthodontics and Periodontics, Division of Periodontics, Piracicaba Dental School

Study Record Dates

• First Submitted: September 13, 2014
• First Posted: September 17, 2014
• Study Start: December 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

BR (1)