Clinical trial 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).
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Deep Caries
Keywords: Deep carious lesion
incomplete caries removal
antibacterial adhesive system
dental composite resin
pulp vitality preservation
randomized controlled trial
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 464
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Exclusion Criteria:

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).

Primary outcomes:
measure: 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)
timeFrame: one year of follow-up.
Secondary outcomes:
measure: Contribution of the functional and biological dimensions of the five FDI criteria items
timeFrame: At one year of follow-up.
measure: 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.
timeFrame: At two and three years of follow-up.
measure: 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.
timeFrame: At one, two and three years of follow-up.
measure: 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.
timeFrame: At one, two and three years of follow-up.
measure: Description of the Consequences of Failures per Treatment Arm
timeFrame: At one, two and three years of follow-up.
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Hôpital Estaing
city: Creteil
country: France
facility: Hôpital Albert Chenevier
city: Grenay
country: France
facility: Cabinet Libéral
city: IVRY SUR SEINE Cedex
country: France
facility: Hôpital Charles Foix
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Service de consultations et traitements dentaires
city: Marseille
country: France
facility: Hôpital de la Timone
city: Nantes
country: France
facility: CHRU de Nantes
city: Nice
country: France
facility: CHU Nice
city: PARIS Cedex 12
country: France
facility: APAH Rothschild- Garancière
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpétrière
city: Paris
country: France
facility: Cabinet Libéral
city: Pessac
country: France
facility: Hopital Xavier Arnozan
city: Rennes
country: France
facility: CHRU Rennes
city: Toulouse
country: France
facility: CHRU Toulouse
Study officials:
affiliation: Hospices Civils de Lyon
name: BRIGITTE GROSGOGEAT, Professor
role: STUDY_DIRECTOR
References:
citation: 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.