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

NCT02456337 — Phase 4, Completed, 49 participants, University of Campinas, Brazil
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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

RegistryNCT02456337
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment49 (Actual)
SponsorUniversity of Campinas, Brazil (Other); collaborators: University of Sao Paulo
ConditionsGingival Recession
InterventionsMucograft, Emdogain, Coronally Advanced flap (Device, procedure)
Datesstart 2014-07-01, primary completion 2016-09-01, completion 2016-10-01, first posted 2015-05-28, last updated 2016-10-27
Locations1 site in Brazil

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-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
CAF+MC+EMDExperimentalDevice: Mucograft; Device: Emdogain; Procedure: Coronally Advanced flapCoronally Advanced Flap with Mucograft and Emdogain
CAF+MCActive comparatorDevice: Mucograft; Procedure: Coronally Advanced flapCoronally Advanced Flap with Mucograft
CAF+EMDActive comparatorDevice: Emdogain; Procedure: Coronally Advanced flapCoronally Advanced Flap with Emdogain
CAFActive comparatorProcedure: Coronally Advanced flapCoronally Advanced Flap alone
  • 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • Complete root coverage [6 months]: Assessed as percentage of sites with complete root coverage

Other outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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.

+Locations (1)

FacilityCityCountryStatus
Piracicaba Dental School, State University of CampinasPiracicaba, São PauloBrazil

+Publications

  • Results publication: Sangiorgio JPM, Neves FLDS, Rocha Dos Santos M, Franca-Grohmann IL, Casarin RCV, Casati MZ, Santamaria MP, Sallum EA. Xenogenous Collagen Matrix and/or Enamel Matrix Derivative for Treatment of Localized Gingival Recessions: A Randomized Clinical Trial. Part I: Clinical Outcomes. J Periodontol. 2017 Dec;88(12):1309-1318. doi: 10.1902/jop.2017.170126. Epub 2017 Jul 28. PMID 28753100

+Investigators

My Notes