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).
DECAT
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
1 other identifier
interventional
464
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2015
Longer than P75 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedSeptember 29, 2016
September 1, 2016
2.5 years
October 15, 2014
September 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
one year of follow-up.
Secondary Outcomes (5)
Contribution of the functional and biological dimensions of the five FDI criteria items
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.
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.
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.
At one, two and three years of follow-up.
Description of the Consequences of Failures per Treatment Arm
At one, two and three years of follow-up.
Study Arms (4)
Partial excavation
EXPERIMENTALpatients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive
Complete excavation
ACTIVE COMPARATORpatients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive
Antibacterial dental adhesive
EXPERIMENTALpatients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment)
Conventional dental adhesive
ACTIVE COMPARATORpatients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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,
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Hôpital Estaing
Clermont-Ferrand, 63003, France
Hôpital Albert Chenevier
Créteil, 94000, France
Cabinet Libéral
Grenay, 62160, France
Hôpital Charles Foix
Ivry-sur-Seine, 94205, France
CHU Lille
Lille, France
Service de consultations et traitements dentaires
Lyon, 69007, France
Hôpital de la Timone
Marseille, 13385, France
CHRU de Nantes
Nantes, 44093, France
CHU Nice
Nice, 06003, France
Groupe Hospitalier Pitié Salpétrière
Paris, 75013, France
Cabinet Libéral
Paris, 75017, France
APAH Rothschild- Garancière
Paris, 75571, France
Hopital Xavier Arnozan
Pessac, 33604, France
CHRU Rennes
Rennes, 35033, France
CHRU Toulouse
Toulouse, 31059, France
Related Publications (1)
Villat C, Attal JP, Brulat N, Decup F, Domejean S, Dursun E, Fron-Chabouis H, Jacquot B, Muller Bolla M, Plasse-Pradelle N, Roche L, Maucort-Boulch D, Nony P, Gritsch K, Millet P, Gueyffier F, Grosgogeat B. One-step partial or complete caries removal and bonding with antibacterial or traditional self-etch adhesives: study protocol for a randomized controlled trial. Trials. 2016 Aug 15;17(1):404. doi: 10.1186/s13063-016-1484-0.
PMID: 27527342DERIVED
Study Officials
- STUDY DIRECTOR
BRIGITTE GROSGOGEAT, Professor
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2014
First Posted
November 7, 2014
Study Start
February 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2020
Last Updated
September 29, 2016
Record last verified: 2016-09