NCT02286388

Multicenter 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).

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 464 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 8 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Deep Caries

Interventions

Type	Name	Description
PROCEDURE	A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.	Instruments and procedures: * Soprolife® (Acteon, La Ciotat, France) dental imaging device to detect dentinal infection status. The green-black light indicates infected dentin, red indicates infected/affected dentin and green indicates healthy dentinal tissue. * Sterile round bur under water spray coolant followed by final excavation with hand instruments The clinician will remove the superficial necrotic and demineralized dentin with complete excavation of the peripheral demineralized dentin, avoiding excavation close to the pulp. Hand instruments will be used for final excavation following clinical criteria guidelines (color of residual dentin and probe resistance) and taking in to consideration the color data obtained by the Soprolife® camera. The operator will stop excavating when the dentin close to the pulp appears red (for infected dentin).
PROCEDURE	A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.	Instruments and procedures: Idem partial excavation arm. In the complete excavation arm, the operator will stop excavating when the dentin close to the pulp appears green (for healthy dentin tissue) using the Soprolife® camera, leaving no infected or affected dentin.
DEVICE	The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental).	Enamel and dentin will be conditioned according to the manufacturer's instructions. Both antibacterial and conventional adhesives are two-steps bonding systems. The first step consists of the application of a primer to the enamel and dentin for 20 seconds (which allows the completion of etching and priming procedures). The second step consists of the application of the antibacterial adhesive and its light curing for 10 seconds.
DEVICE	The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental)	Idem antibacterial dental adhesive arm. A conventional dental adhesive will be used instead of an antibacterial.

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-08-01
• Completion: 2020-08-01
• First posted: 2014-11-07
• Last updated: 2016-09-29

Locations

15 sites across 1 country: France