Back to resultsCoronally Advanced Flap With or Without Porcine Collagen Matrix for Root Coverage
Primary Purpose
Gingival Recession
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Coronally Advanced Flap
Mucograft
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring Gingival recession/surgery, Collagen/therapeutic use, Root coverage, Treatment outcome
Eligibility Criteria
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.
Sites / Locations
- Piracicaba Dental School, State University of Campinas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Coronally advanced flap + Mucograft
Coronally advanced flap
Arm Description
coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft
Coronally advanced flap procedure alone
Outcomes
Primary Outcome Measures
Recession Reduction
Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.
Secondary Outcome Measures
Complete root coverage
Assessed as percentage of sites with complete root coverage
Full Information
NCT ID
NCT02242500
First Posted
September 13, 2014
Last Updated
December 26, 2015
Sponsor
Enilson Antonio Sallum
Collaborators
University of Bern
1. Study Identification
Unique Protocol Identification Number
NCT02242500
Brief Title
Coronally Advanced Flap With or Without Porcine Collagen Matrix for Root Coverage
Official Title
Phase IV Study of Coronally Advanced Flap With or Without Porcine Collagen Matrix for Treatment of Gingival Recession: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Enilson Antonio Sallum
Collaborators
University of Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Gingival recession/surgery, Collagen/therapeutic use, Root coverage, Treatment outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coronally advanced flap + Mucograft
Arm Type
Experimental
Arm Description
coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft
Arm Title
Coronally advanced flap
Arm Type
Other
Arm Description
Coronally advanced flap procedure alone
Intervention Type
Procedure
Intervention Name(s)
Coronally Advanced Flap
Intervention Type
Device
Intervention Name(s)
Mucograft
Other Intervention Name(s)
Porcine collagen matrix for soft tissue regeneration
Primary Outcome Measure Information:
Title
Recession Reduction
Description
Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complete root coverage
Description
Assessed as percentage of sites with complete root coverage
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Keratinized tissue thickness
Description
Measured at a midpoint between gingival margin and mucogingival junction using a endodontic spreader pierced perpendicular and through the soft tissue
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Piracicaba Dental School, State University of Campinas
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414-903
Country
Brazil
12. IPD Sharing Statement
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Coronally Advanced Flap With or Without Porcine Collagen Matrix for Root Coverage
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