Back to resultsXenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions
Primary Purpose
Gingival Recession, Generalized
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Use of XCM for the treatment of MAGRs with mCAF technique
Treatment of MAGRs with CTG
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession, Generalized
Eligibility Criteria
Inclusion Criteria: At least 18 years old and able to sign informed consent At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest Available to attend study related procedures (including follow-up visits) Exclusion Criteria: Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus); Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers; Pregnant or nursing women; History of previous periodontal surgery (mucogingival or other) on the teeth to be included; Furcation involvement in the teeth to be included; Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated; Presence of fixed or removable prosthesis in the area to be treated
Sites / Locations
- CIR Dental SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Xenogenic collagen matrix (XCM)
Connective tissue graft (CTG)
Arm Description
Multiple coronally advanced flap technique (mCAF) with the use of a XCM
Multiple coronally advanced flap technique (mCAF) with the use of a CTG
Outcomes
Primary Outcome Measures
Mean Recession Reduction (RecRed)
Mean changes in mm in recession depth between baseline and 1-year
Secondary Outcome Measures
Complete Root Coverage (CRC)
Percentage of sites with complete root coverage after 1-year
Mean Root Coverage (MRC)
Percentage of mean root coverage after 1-year
Keratinised tissue height (KTH) changes
Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year
Post-operative morbidity (pain, swelling, discomfort)
Assessment of patient's pain, swelling and discomfort at 14 days after the procedure using visual analogue scale (VAS) ranging from 0 (no pain, swelling or discomfort) to 10 (maximum pain, swelling or discomfort) with a questionnaire
Full Information
NCT ID
NCT05693753
First Posted
January 11, 2023
Last Updated
June 26, 2023
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT05693753
Brief Title
Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions
Official Title
Coronally Advanced Flap With Xenogenic Collagen Matrix or Autogenous Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recessions: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
June 2, 2024 (Anticipated)
Study Completion Date
December 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Turin, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this study is to evaluate whether the use of a xenogenic collagen matrix (XCM) for the treatment of multiple adjacent gingival recessions (MAGRs) with a multiple coronally advanced flap technique (mCAF) achieves better results than the use of an autologous connective tissue graft (CTG) in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding). The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM is not inferior to CTG in terms of recessions reduction and secondary clinical variables, and superior regarding to PROMs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Generalized
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xenogenic collagen matrix (XCM)
Arm Type
Experimental
Arm Description
Multiple coronally advanced flap technique (mCAF) with the use of a XCM
Arm Title
Connective tissue graft (CTG)
Arm Type
Active Comparator
Arm Description
Multiple coronally advanced flap technique (mCAF) with the use of a CTG
Intervention Type
Device
Intervention Name(s)
Use of XCM for the treatment of MAGRs with mCAF technique
Intervention Description
After local anaesthesia, mCAF technique will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.
Intervention Type
Procedure
Intervention Name(s)
Treatment of MAGRs with CTG
Intervention Description
After local anaesthesia, mCAF technique will be performed. CTG will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.
Primary Outcome Measure Information:
Title
Mean Recession Reduction (RecRed)
Description
Mean changes in mm in recession depth between baseline and 1-year
Time Frame
6 months; 1 year
Secondary Outcome Measure Information:
Title
Complete Root Coverage (CRC)
Description
Percentage of sites with complete root coverage after 1-year
Time Frame
6 months; 1 year
Title
Mean Root Coverage (MRC)
Description
Percentage of mean root coverage after 1-year
Time Frame
6 months; 1 year
Title
Keratinised tissue height (KTH) changes
Description
Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year
Time Frame
6 months; 1 year
Title
Post-operative morbidity (pain, swelling, discomfort)
Description
Assessment of patient's pain, swelling and discomfort at 14 days after the procedure using visual analogue scale (VAS) ranging from 0 (no pain, swelling or discomfort) to 10 (maximum pain, swelling or discomfort) with a questionnaire
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 18 years old and able to sign informed consent
At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment
A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest
Available to attend study related procedures (including follow-up visits)
Exclusion Criteria:
Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);
Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;
Pregnant or nursing women;
History of previous periodontal surgery (mucogingival or other) on the teeth to be included;
Furcation involvement in the teeth to be included;
Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated;
Presence of fixed or removable prosthesis in the area to be treated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Aimetti, MD
Phone
0116331546
Email
mario.aimetti@unito.it
Facility Information:
Facility Name
CIR Dental School
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Aimetti, Prof.
Phone
+39116331541
Email
mario.aimetti@unito.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions
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