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Completed

NCT Number: NCT02456337

Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage

The purpose of this study is to evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins.

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Key information

Conditions

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

Age range

18 year–60 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 ≥ 2.5 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

Mucograft

Device

Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.

Emdogain

Device

Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.

coronally advanced flap

Procedure

Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.

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

University of Campinas, Brazil

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

Xenogenous Collagen Matrix Graft Associated or Not With Enamel Matrix Derivative Proteins in the Treatment of Gingival Recession Class I and II of Miller: Randomized Controlled Clinical Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 28, 2015
Registry last updated
Oct 27, 2016

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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