• Effects of Partical Excavation in One Versus Two Procedures of Primary Deep Caries (PAPRICA)

  NCT03696498

  Unknown statusInterventionalNot ApplicableUpdated Feb 13, 2024
• Selective Removal Technique With or Without a Bioactive Material for Deep Caries Lesions

  NCT04743219

  Unknown statusInterventionalNot ApplicableUpdated Nov 21, 2022
• Selective or Stepwise Removal of Deep Caries

  NCT02232828

  Unknown statusInterventionalNot ApplicableUpdated Jul 28, 2015
• Partial Removal of Caries Dentines

  NCT00887952

  Unknown statusInterventionalNot ApplicableUpdated Dec 30, 2009
• Selective Versus Stepwise Removal of Deep Carious Lesions in Permanent Teeth Using Different Medicaments

  NCT06585436

  CompletedInterventionalNot ApplicableUpdated Sep 5, 2024
• Pulp Protection in Selective Carious Tissue Removal

  NCT04250142

  CompletedInterventionalNot ApplicableUpdated Dec 28, 2022

ClinicalTrials.gov ID

NCT02286388

Lead Sponsor

Hospices Civils de LyonOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

464Estimated

Last Update Posted

Sep 29, 2016Estimated

Start Date

Feb 2015

Primary Completion Date

Aug 2017Estimated

Completion Date

Aug 2020Estimated

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

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.

• Deep Caries

• A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.
• A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.
• The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental).
• The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental)

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Hospices Civils de LyonOTHER

marc.linez@univ-lille2.fr+33 6 42 53 80 79

nathalie.brulat@unice.fr+33 6 95 37 73 59