Partial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions
- Conditions
- Gingival Recession
- Interventions
- Procedure: Split-thickness non-advanced tunnel (Zabalegui et al. 1999)Procedure: Full-thickness coronally-advanced tunnel (Aroca et al. 2010)
- Registration Number
- NCT05655247
- Lead Sponsor
- Universidad Complutense de Madrid
- Brief Summary
Included patients will be randomly allocated to the test (split-thickness non-advanced tunnel - Zabalegui et al. 1999) or to the control group (full-thickness coronally-advanced tunnel - MCAT - Aroca et al. 2010).
- Detailed Description
Design: Randomized, clinical, outcome-assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio. The follow-up of individual patients will be 6 months (to be extended to 3/5 years if funding will be available)
Patients with a minimum of two-adjacent teeth with RT1 and/or RT2 gingival recessions (at least one with a depth \>2 mm) with indication for root coverage treatment will be included. RT2 gingival recessions will be considered not eligible when associated with interproximal exposure of the CEJ.
Mean root coverage (linear) at 6-months will be evaluated as the primary outcome by a blinded outcome assessor.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Split-thickness non-advanced tunnel (Zabalegui et al. 1999) Split-thickness non-advanced tunnel (Zabalegui et al. 1999) - Full-thickness coronally-advanced tunnel (Aroca et al. 2010) Full-thickness coronally-advanced tunnel (Aroca et al. 2010) Modified Coronally Advanced Tunnel (MCAT)
- Primary Outcome Measures
Name Time Method Mean Root Coverage (MRC) (6 months) 6 months after surgery Defined as the percentage of root coverage in the mid-buccal aspect obtained with respect to baseline. The MRC will be measured as a percentage (% mm, with probe) 6 months after surgery. Considering the study will also include RT2 gingival recessions (we expect CRC not possible in some cases), the linear 6 months MRC will be evaluated as the primary outcome of the study.
- Secondary Outcome Measures
Name Time Method Recession Reduction (RR) 3 and 6 months after surgery Defined as the reduction in recession in the mid-buccal aspect with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated as linear mid-buccal measurement (mm, with probe).
Contact-point/Papilla-tip (DCP) distance changes 3 and 6 months after surgery Defined as the change in the linear distance between the contact point and the top of papilla at the mesial aspect of each tooth (Aroca et al. 2010) with respect to baseline. It will be measured at 3- and 6-months after surgery and evaluated as linear measurement (mm, with probe).
Keratinized Tissue Height (KTH) changes 3 and 6 months after surgery Defined as the linear changes in mid-buccal keratinized tissue height (distance from the gingival margin and the mucogingival junction) with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated as linear mid-buccal measurement (mm, with probe).
Probing Pocket Depth (PPD) changes 3 and 6 months after surgery Defined as the changes in PPD (distance from the gingival margin to the bottom of the probeable sulcus) with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated only as linear mid-buccal measurement (mm, with probe).
Clinical Attachment Level (CAL) changes 3 and 6 months after surgery Defined as the changes in CAL (distance from the CEJ to the bottom of the probeable sulcus) with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated only as linear mid-buccal measurement (mm, with probe).
Dental hypersensitivity (DH) 3 and 6 months after surgery Assessed by 10 s air spray applied to the buccal cervical area. It will be evaluated at baseline and at 3- and 6-months after surgery.
Mean Root Coverage (MRC) (3 months) 3 months after surgery Defined as the percentage of root coverage in the mid-buccal aspect obtained with respect to baseline. The MRC will be measured as a percentage (% mm, with probe) 3 months after surgery.
Complete Root Coverage (CRC) 3 and 6 months after surgery Defined as the presence/absence of complete root coverage in the mid-buccal aspect. It will be measured at 3- and 6-months after surgery and evaluated as linear mid-buccal measurement (mm, with probe).
Root-coverage Esthetic Score (RES) 3 and 6 months after surgery Evaluated at 3- and 6-months according to Cairo et al. (2009).
Digital Mean Root Coverage (dMRC) 3 and 6 months after surgery Defined as the percentage of root surface coverage obtained with respect to baseline. The sMRC will be measured at 3- and 6-months after surgery. It will be assessed as buccal surface measurement (% mm2, digital assessment).
Digital Complete Root Coverage (dCRC) 3 and 6 months after surgery Defined as the presence/absence of complete root surface coverage. It will be measured at 3- and 6-months after surgery and evaluated as buccal surface measurement (mm2, digital assessment).
Digital Recession Reduction (dRR) 3 and 6 months after surgery Defined as the reduction in recession surface with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated as buccal surface measurement (mm2, digital assessment).
Digital Contact-point/Papilla-tip (dDCP) distance changes 3 and 6 months after surgery Defined as the changes in the area between the contact point and the top of papilla at the mesial aspect of each tooth with respect to baseline. It will be measured at 3- and 6-months after surgery and evaluated as area measurement (mm2, digital assessment).
Digital Gingival thickness (dGT) 3 and 6 months after surgery It will be measured both at the gingival margin and 1-mm apically. It will be assessed as a mid-buccal thickness measurement (mm, digital assessment) at 3- and 6-months after surgery.
Digital Keratinized Tissue Height (dKTH) changes 3 and 6 months after surgery Defined as the changes in keratinized tissue surface (surface delimited apico-coronally by the gingival margin and the mucogingival junction and mesio-distally by the projection of a line passing by the contact-point and perpendicular to the occlusal aspect of each tooth) with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated as buccal surface measurement (mm2, digital assessment).
Trial Locations
- Locations (1)
Universidad Complutense de Madrid
🇮🇹Taranto, Italy