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

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Device: Mucograft; Device: Emdogain; Procedure: Coronally Advanced flap

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Piracicaba, São Paulo, Brazil, 13414-903
      • Piracicaba Dental School, State University of Campinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAF+MC+EMD; Coronally Advanced Flap with Mucograft and Emdogain	Device: Mucograft; Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.; Device: Emdogain; Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.; Procedure: Coronally Advanced flap; Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.
Active Comparator: CAF+MC; Coronally Advanced Flap with Mucograft	Device: Mucograft; Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.; Procedure: Coronally Advanced flap; Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.
Active Comparator: CAF+EMD; Coronally Advanced Flap with Emdogain	Device: Emdogain; Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.; Procedure: Coronally Advanced flap; Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.
Active Comparator: CAF; Coronally Advanced Flap alone	Procedure: Coronally Advanced flap; Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil
• Collaborators: University of Sao Paulo
• Investigators: Study Chair: Enilson A Sallum, PhD, University of Campinas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 25, 2015
• First Submitted That Met QC Criteria: May 25, 2015
• First Posted (Estimate): May 28, 2015

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Gingival Recession; Periodontal regeneration; Coronally advanced flap
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 067/2013; 2013/19473-6 (Other Grant/Funding Number: FAPESP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO