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).

Deep Caries Clinical Trial

— DECAT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02286388
• Other study ID #: 2014-854
• Status: Recruiting
• Phase: Phase 3
• First received: October 15, 2014
• Last updated: September 28, 2016
• Start date: February 2015
• Est. completion date: August 2020

Study information

• Verified date: September 2016
• Source: Hospices Civils de Lyon
• Contact: BRIGITTE GROSGOGEAT, Professor
• Phone: 04 78 77 86 89
• Email: brigitte.grosgogeat[@]univ-lyon1.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 464
• Est. completion date: August 2020
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 80 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Caries
• Dental Caries

Intervention

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).
• 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.
• 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.

Locations

Country	Name	City	State
France	Hôpital Estaing	Clermont Ferrand
France	Hôpital Albert Chenevier	Creteil
France	Cabinet Libéral	Grenay
France	Hôpital Charles Foix	IVRY SUR SEINE Cedex
France	CHU Lille	Lille
France	Service de consultations et traitements dentaires	Lyon
France	Hôpital de la Timone	Marseille
France	CHRU de Nantes	Nantes
France	CHU Nice	Nice
France	Cabinet Libéral	Paris
France	Groupe Hospitalier Pitié Salpétrière	Paris
France	APAH Rothschild- Garancière	PARIS Cedex 12
France	Hopital Xavier Arnozan	Pessac
France	CHRU Rennes	Rennes
France	CHRU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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	At one year of follow-up.	Yes
Secondary	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)	At two and three years of follow-up.	Yes
Secondary	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)	At one, two and three years of follow-up.	Yes
Secondary	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)	At one, two and three years of follow-up.	Yes
Secondary	Description of the Consequences of Failures per Treatment Arm	total number of visits, need for endodontic treatment, need for extraction	At one, two and three years of follow-up.	Yes