Informations générales (source: ClinicalTrials.gov)
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 (DECAT)
Interventional
Phase 3
Hospices Civils de Lyon (Voir sur ClinicalTrials)
février 2015
août 2020
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CDS DENTAIRE PONT CARDINET | DECUP Franck | Contact (sur clinicalTrials) | |||
| ECOLE HOPITAL CHARLES FOIX (AP-HP) | FRON-CHABOUIS Hélène | Contact (sur clinicalTrials) | |||
| IFSI DU GROUPE HOSP. PITIÉ SALPÉTRIÈRE | BOSCO Julia | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU Toulouse - 31059 - Toulouse - France | JONIOT Sabine | Contact (sur clinicalTrials) | |||
| CHU Lille - Lille - France | LINEZ Marc | Contact (sur clinicalTrials) | |||
| CHU Nice - 06003 - Nice - France | BRULAT Nathalie | Contact (sur clinicalTrials) | |||
| Hôpital Albert Chenevier - 94000 - Creteil - France | DURSUN Elisabeth | Contact (sur clinicalTrials) | |||
| Hôpital Estaing - 63003 - Clermont Ferrand - France | DOMEJEAN Sophie | Contact (sur clinicalTrials) | |||
| Hopital Xavier Arnozan - 33604 - Pessac - France | Dominique ORIEZ-PONS | Contact (sur clinicalTrials) | |||
| Service de consultations et traitements dentaires - 69007 - Lyon - France | VILLAT Cyril | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APAH Rothschild- Garancière - 75571 - PARIS Cedex 12 - France | PLASSE-PRADELLE Nelly | Contact (sur clinicalTrials) | |||
| Cabinet Libéral - 62160 - Grenay - France | TRENTESAUX Thomas | Contact (sur clinicalTrials) | |||
| CHRU de Nantes - 44093 - Nantes - France | WEISS Pierre | Contact (sur clinicalTrials) | |||
| CHRU Rennes - 35033 - Rennes - France | TURPIN Yann-Loïg | Contact (sur clinicalTrials) | |||
| Hôpital de la Timone - 13385 - Marseille - France | RASKIN Anne | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
Randomization n°1 - Partial versus complete caries removal
Patient-related criteria:
- Patient consulting in one of the multicenter trial centers
- Male and female aged 8-80 (inclusive),
- Affiliated to a social security regimen
- Able to tolerate necessary restorative procedures
- Provide informed consent
- Accepts the three-year follow-up period
Tooth related criteria:
- Mature permanent posterior tooth
- Tooth with vital pulp according to pulp-sensitivity tests
- Tooth with a deep (primary or secondary) at least proximal and/or occlusal carious
lesion presenting a residual dentin thickness with no continuity between the carious
cavity and the pulp chamber.
- In case of proximal lesions, the proximal cervical limit must allow proper placement
of a waterproof dental dam (confirmed by a bitewing X-ray radiograph)
- Tooth requiring a direct partial restorative treatment.
Randomization n°2 - Antibacterial vs. non antibacterial adhesive application
Tooth has been assigned a treatment by randomization n°1.
Randomization n°1 - Partial versus complete caries removal
Patient-related criteria:
- Patient consulting in one of the multicenter trial centers
- Male and female aged 8-80 (inclusive),
- Affiliated to a social security regimen
- Able to tolerate necessary restorative procedures
- Provide informed consent
- Accepts the three-year follow-up period
Tooth related criteria:
- Mature permanent posterior tooth
- Tooth with vital pulp according to pulp-sensitivity tests
- Tooth with a deep (primary or secondary) at least proximal and/or occlusal carious
lesion presenting a residual dentin thickness with no continuity between the carious
cavity and the pulp chamber.
- In case of proximal lesions, the proximal cervical limit must allow proper placement
of a waterproof dental dam (confirmed by a bitewing X-ray radiograph)
- Tooth requiring a direct partial restorative treatment.
Randomization n°2 - Antibacterial vs. non antibacterial adhesive application
Tooth has been assigned a treatment by randomization n°1.
Randomization n°1 - Partial versus complete caries removal
Patient-related criteria:
- Person under guardianship, pregnant or nursing woman,
- Risk of infectious endocarditis,
- Patient who has an implanted Cardiac Pacemaker/Defibrillator
- Patient with severe periodontal disease (pocket depth ≥5mm and/or mobility type IV),
- Poor oral hygiene (abundance of soft matter within the gingival pocket and/or on the
tooth and gingival margin = score 3 [Silness and Loe, 1964],
- Allergy to any of the materials and/or anaesthetic used,
- Uncooperative patients.
Tooth related criteria:
- Nocturnal pain causing insomnia,
- Tooth suffering dentin hypersensitivity (sharp sudden pain of short duration pain
arising from exposed dentin (erosion and/or gingival recession), typically in
response to external stimuli (air blast hypersensitivity [Schiff et al., 1994],
tactile hypersensitivity),
- Sensitivity to axial or lateral percussion;
- Radiolucent apical image,
- Condensing osteitis,
- Tooth having an external or internal resorption,
- Tooth having suffered trauma,
- Tooth with a carious cervical lesion,
- Tooth with an occlusal wear associated to a dentine exposure,
- Tooth supporting clasp of a removable partial denture (RPD).
- Tooth with defects of mineralization that once the treated tooth could come into
contact of the carried out restoration
Randomization n°2 - Antibacterial vs. non antibacterial adhesive application
- Tooth with pulp exposure after randomization n°1 requiring endodontic treatment
(pulp exposure > 2 mm² and/or haemostasis not obtained).