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Completed

NCT Number: NCT02242500

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

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

coronally advanced flap

Procedure

Mucograft

Device

Other names: Porcine collagen matrix for soft tissue regeneration

Primary outcomes

  1. Recession Reduction

    Time frame: 6 months

    Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.

Secondary outcomes

  1. Complete root coverage

    Time frame: 6 months

    Assessed as percentage of sites with complete root coverage

Other outcomes

  1. Keratinized tissue thickness

    Time frame: 6 months

    Measured at a midpoint between gingival margin and mucogingival junction using a endodontic spreader pierced perpendicular and through the soft tissue

Sponsors and collaborators

Lead sponsor

Enilson Antonio Sallum

Other

Collaborators

  • University of Bern

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 17, 2014
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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