Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions
- Conditions
- Gingival Recession, Generalized
- Interventions
- Procedure: Treatment of MAGRs with CTGDevice: Use of XCM for the treatment of MAGRs with mCAF technique
- Registration Number
- NCT05693753
- Lead Sponsor
- University of Turin, Italy
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Connective tissue graft (CTG) Treatment of MAGRs with CTG Multiple coronally advanced flap technique (mCAF) with the use of a CTG Xenogenic collagen matrix (XCM) Use of XCM for the treatment of MAGRs with mCAF technique Multiple coronally advanced flap technique (mCAF) with the use of a XCM
- Primary Outcome Measures
Name Time Method Mean Recession Reduction (RecRed) 6 months; 1 year Mean changes in mm in recession depth between baseline and 1-year
- Secondary Outcome Measures
Name Time Method Mean Root Coverage (MRC) 6 months; 1 year Percentage of mean root coverage after 1-year
Post-operative morbidity (pain, swelling, discomfort) 14 days 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
Keratinised tissue height (KTH) changes 6 months; 1 year Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year
Complete Root Coverage (CRC) 6 months; 1 year Percentage of sites with complete root coverage after 1-year
Trial Locations
- Locations (1)
CIR Dental School
🇮🇹Turin, Italy