- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03619096
Two Different Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix
Clinical Comparison Between Two Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix
The gold standard for gingival recession treatment is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The porcine collagen matrix (PCR) has been used as a substitute for subepithelial connective tissue graft in periodontal plastic surgery and has achieved similar results. The PCR use has the advantage of avoiding possible pre and postoperative complications , as well as overcome the limitations presented by autograft . The different surgical techniques used for root coverage seek predictability and success . For this, besides the type of incision placements flap and graft are the most important because the healing benefits and outcome .
The aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better clinical outcomes and less morbidity . 20 adults , nonsmoking patients , showing multiple bilateral gingival recessions , class I or II Miller located in canine, first and second premolars are selected. Both techniques use the PCR as a graft . However, in one Quadrant partial flap will be held together with relaxing incisions through an intrasulcular incision, PCR will be positioned 1 mm apical to the cementoenamel junction (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant periosteal envelope that does not use relaxing incisions, avoiding any scars, will be performed with the PCR. The clinical parameters (gingival recession height and width, keratinized tissue thickness and width) will be evaluated 2 weeks after basic periodontal therapy and after 6 and 12 months to surgical procedures..
Study Overview
Status
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
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Ribeirão Preto, São Paulo, Brazil
- Marilia Bianchini Lemos Reis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm of gingival recession height
Exclusion Criteria:
- diabetics
- pregnant women
- chronic use of medication
- periodontitis
- smokers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Test Group (tunnel technique)
It Will be performed root coverage of multiple recessions using porcine collagen matrix with a tunnel Technique
|
Tunnel technique for root coverage for multiple gingival recessions, using porcine collagen matrix
Other Names:
|
|
Placebo Comparator: Control Group (extended flap technique)
It Will be performed root coverage of multiple recessions using porcine collagen matrix with a extended flap technique
|
Extended flap technique for root coverage for multiple gingival recessions, using porcine collagen matrix
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in gingival recession height (mm)
Time Frame: baseline, 6, and 12 months
|
Gingival recession height will be measured at baseline, 6 months, and 12 months.
The primary outcome will be the change in gingival recession height from baseline to 12 months.
|
baseline, 6, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Keratinized tissue width and thickness (mm)
Time Frame: baseline, 6, and 12 months
|
Keratinized tissue width and thickness will be measured at baseline, 6 months, and 12 months.
|
baseline, 6, and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arthur Belem Novaes JR, University of Sao Paulo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE:65396417000005419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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