Status:
UNKNOWN
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).
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Deep Caries
Eligibility:
All Genders
8-80 years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
464 Patients enrolled
Trial Details
Trial ID
NCT02286388
Start Date
February 1 2015
End Date
August 1 2020
Last Update
September 29 2016
Active Locations (15)
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1
Hôpital Estaing
Clermont-Ferrand, France, 63003
2
Hôpital Albert Chenevier
Créteil, France, 94000
3
Cabinet Libéral
Grenay, France, 62160
4
Hôpital Charles Foix
Ivry-sur-Seine, France, 94205