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Completed

NCT Number: NCT02459704

Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Gingival Recessions

The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients will receive EMD associated to SCPF, while the other half, will receive SCPF alone.

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Key information

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

About this study

The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be selected, randomized and allocated in two groups: test group (SCPF + EMD) and control group (SCPF). The subjects will should present buccal Miller class I gingival recessions with height greater than or equal to 2.0 mm and less than to 4.0 mm in maxillary canines or premolars. Clinical parameters will be evaluated: gingival recession height (GRH), gingival recession width(GRW), clinical attachment level (CAL), probing depth (PD), height (HKT) and thickness (TKT) of keratinized tissue and papillas height (HP) and width(LP), as well as plaque and gingival index. These data will be collected at baseline and 180 days after surgery.

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 Miller Class I gingival recession ≥ 2 mm or ≤ 4mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ);
  • Height of keratinized tissue ≥ 2 mm;
  • 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

semilunar coronally positioned flap

Procedure

Semilunar coronally positioned flap with enamel matrix derivative (Emdogain) or alone.

Enamel matrix derivative (Emdogain)

Device

Enamel matrix derivative associated to semilunar coronally positioned flap (SCPF + EMD - test group)

Primary outcomes

  1. Change in Recession Reduction as measured by difference between gingival recession depth

    Time frame: Baseline, 12 months

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

Secondary outcomes

  1. Complete root coverage

    Time frame: 12 months

    Assessed as percentage of sites with complete root coverage

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Miller Class I Gingival Recessions: Randomized Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2015
Registry last updated
Oct 8, 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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