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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
464
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).
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.
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.
Idem antibacterial dental adhesive arm. A conventional dental adhesive will be used instead of an antibacterial.
Hôpital Estaing
Clermont-Ferrand, France
RECRUITINGHôpital Albert Chenevier
Créteil, France
RECRUITINGCabinet Libéral
Grenay, France
RECRUITINGHôpital Charles Foix
Ivry-sur-Seine, France
RECRUITINGCHU Lille
Lille, France
RECRUITINGService de consultations et traitements dentaires
Lyon, France
RECRUITINGHôpital de la Timone
Marseille, France
RECRUITINGCHRU de Nantes
Nantes, France
RECRUITINGCHU Nice
Nice, France
RECRUITINGGroupe Hospitalier Pitié Salpétrière
Paris, France
RECRUITING...and 5 more locations
Probability of success in arm P (Partial Caries Removal) compared to arm C (Complete Caries Removal) using a composite criteria of success summarized as a binary success criteria (cf. description below)
Cases will be considered as successful if each of the 5 following criteria described by the World Dental Federation (FDI) present a score of 3 or less: * Fracture of material and retention (item 5) * Marginal adaptation (item 6) * Radiographic examination (including apical pathologies) (item 9) * Post-operative sensitivity and tooth vitality (item 11) * Recurrence of caries (item 12) Criteria 5, 6 and 9 are functional criteria while criteria 11 and 12 are biological criteria. Considering a score of 4 or 5 as failure means that a re-intervention on the tooth (score 4) would be considered as a failure in the context of this study. Adverse events will be recorded and reported as general safety outcomes.
Time frame: one year of follow-up.
Contribution of the functional and biological dimensions of the five FDI criteria items
Assessment of the relative importance of each of the 5 FDI criteria in determining failure for both the primary outcome
Time frame: At one year of follow-up.
Probability of success in arm P (Partial Caries Removal) compared to arm C (Complete Caries Removal) using a composite criteria of success summarized as a binary success criteria, at two and three years of follow-up.
same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)
Time frame: At two and three years of follow-up.
Probability of success after the use of an antibacterial adhesive compared to the use of a non-antibacterial adhesive using a composite criteria of success summarized as a binary success criteria, at one, two and three years of follow-up.
same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)
Time frame: At one, two and three years of follow-up.
Identification of predictive factors of clinical success from among the following list: presence of post-operative pain, age of patient, type of the carious lesion, location of the carious lesion (occlusal or proximal) and pulp exposure.
the dependent variable (clinical success) corresponds to the same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)
Time frame: At one, two and three years of follow-up.
Description of the Consequences of Failures per Treatment Arm
total number of visits, need for endodontic treatment, need for extraction
Time frame: At one, two and three years of follow-up.
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