Deep Caries Clinical Trial
Official title:
Multicenter Randomized Controlled Trial Comparing One-step Partial Caries Removal to Complete Caries Removal for the Treatment of Deep Carious Lesions in Permanent Teeth DECAT DEep CAries Treatment
This clinical trial is a national multicenter randomized controlled trial performed in
parallel groups aiming to validate a treatment that preserves pulp vitality of mature
permanent posterior teeth through partial removal of carious tissue and restoring tooth
structure using a simple filling in one session, thus delaying premature tooth aging.
Two successive randomizations will be performed (allocation ratio 1:1); firstly for the type
of excavation carried out (partial vs. complete caries removal) and secondly for the nature
of the adhesive used (antibacterial adhesive vs. non-antibacterial adhesive). The second
randomization will not be carried out for teeth requiring endodontic treatment after the
first randomization.
The study's primary objective will be to compare, at 1 year of follow-up, the efficacy
(binary success criteria) of partial caries removal versus complete caries removal in
occlusal or proximal deep lesions of mature permanent posterior teeth (bicuspids and molars
except third molars). Secondary objectives will include the comparison, at 1 year of
follow-up, of the efficacy (binary success criteria) of an antibacterial two-step self-etch
adhesive versus a traditional non-antibacterial two-step self-etch adhesive. Another
secondary objective will be to compare, at two and three years of follow-up, the efficacy of
partial versus complete caries removal.
The primary outcome is the success of the caries removal protocol at one year, measured
according to 5 FDI criteria, while the secondary outcome is the contribution of the
functional and biological dimensions of the 5 FDI criteria items to determining success or
failure of the treatment. The outcome of success will be the same for all objectives,
primary and secondary.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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