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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02242500

Enrollment

Registered

2014-09-17

Start date

2010-12-31

Completion date

2013-10-31

Last updated

2015-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

Keywords

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

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.

Interventions

PROCEDURECoronally Advanced Flap

DEVICEMucograft

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Recession Reduction	6 months	Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.

Secondary

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

Other

Measure	Time frame	Description
Keratinized tissue thickness	6 months	Measured at a midpoint between gingival margin and mucogingival junction using a endodontic spreader pierced perpendicular and through the soft tissue

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026