Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions A Multicenter Randomized Clinical Trial.
Primary Purpose
Gingival Recession
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Porcine acellular dermal matrix
Coronally advanced flap (CAF)
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria: RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be selected to participate in the study; probing depth <3mm, plaque and gingival index < or = a 20%. Exclusion Criteria: Smokers, pregnants, nursing, patients with diabetes mellitus or another condition who interfere in the tissue repair, use of drugs or medications, allergies to any composition of the devices of the study.
Sites / Locations
- Piracicaba Dental School, State University of CampinasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Coronally advanced flap (CAF)
Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM)
Arm Description
Outcomes
Primary Outcome Measures
Recession reduction
Reduction of the gingival recession height
Secondary Outcome Measures
Thickness of keratinized tissue
Thickness of keratinized tissue evaluation after periodontal plastic surgery
Full Information
NCT ID
NCT06006780
First Posted
August 17, 2023
Last Updated
August 22, 2023
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT06006780
Brief Title
Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions A Multicenter Randomized Clinical Trial.
Official Title
Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions: A Multicenter Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim: The aim of this randomized clinical trial is to evaluate the use of the porcine acellular dermal matrix (PADM) for the treatment of RT1 localized gingival recessions.
Material and methods: Forthy patients (n=20) with RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be selected to participate in the study. Patients will be allocated randomly in two treatment groups: Coronally advanced flap (CAF) or coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM). The clinical parameters evaluated at the baseline, 6 and 12 months will be: Plaque index (IPL); gingival index (GI); relative gingival recession height (RGRH); gingival recession width (GRW); probing depth (PD); relative clinical attachment level (RCAL); keratinized tissue height (KTH); keratinized tissue thickness (KTT); papilla height (PH). Evaluations will be made by the professional and the patient regarding dentin hypersensitivity (HD) (Schiff and VAS scales respectively), aesthetics (RES and VAS scales, respectively) and patient's centered outcomes, through the questionnaire referring to the OHIP-14.
Descriptive statistical analysis will be expressed as mean ± standard deviation (SD), median, quartiles, percentages and confidence intervals (95% CI). To analyze the normality of the residue, the Shapiro-Wilk test will be performed. Then, the Wilcoxon test will be applied to compare the periodontal parameters and a quality of life, before and post-treatment. Correlations between parameters and dental hypersensitivity will be analyzed through Spearman's test. Key words: Gingival recession, Root coverage, Biomaterial, Acellular dermal matrix.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Coronally advanced flap (CAF)
Arm Type
Active Comparator
Arm Title
Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Porcine acellular dermal matrix
Other Intervention Name(s)
Mucoderm
Intervention Description
Coronally advanced flap associated with the porcine acellular dermal matrix for root coverage
Intervention Type
Other
Intervention Name(s)
Coronally advanced flap (CAF)
Intervention Description
Coronally advanced flap for root coverage
Primary Outcome Measure Information:
Title
Recession reduction
Description
Reduction of the gingival recession height
Time Frame
Baseline, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Thickness of keratinized tissue
Description
Thickness of keratinized tissue evaluation after periodontal plastic surgery
Time Frame
Baseline, 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be selected to participate in the study; probing depth <3mm, plaque and gingival index < or = a 20%.
Exclusion Criteria:
Smokers, pregnants, nursing, patients with diabetes mellitus or another condition who interfere in the tissue repair, use of drugs or medications, allergies to any composition of the devices of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enilson A. Sallum, PhD
Phone
+55(19)2106-5301
Email
easallum@fop.unicamp.br
Facility Information:
Facility Name
Piracicaba Dental School, State University of Campinas
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enilson A Sallum, PhD
Phone
55 19 21065394
Email
enilson@unicamp.br
First Name & Middle Initial & Last Name & Degree
Enilson A Sallum, PhD
First Name & Middle Initial & Last Name & Degree
Tamires P Dutra, Graduate
First Name & Middle Initial & Last Name & Degree
Isabela LF Grohmann, Master
12. IPD Sharing Statement
Learn more about this trial
Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions A Multicenter Randomized Clinical Trial.
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