No registrations found.
ID
Source
Health condition
Dental caries progression, caries lesion management, cost-effectiveness
Sponsors and support
Intervention
Outcome measures
Primary outcome
- first-attempt success rate
Secondary outcome
- caries progression after two years
- cost-effectiveness from both a medical and societal perspective
- differences in QALYs (CHU-9D)
- differences in dental fear (CFFS-DS)
Background summary
The past 5 years, there is gaining evidence that occlusal dental caries can be inhibited or stopped by sealing the lesion rather than removing all carious tissue and placing a restoration.
This study aims to assess the effectiveness and cost-effectiveness of sealing occlusal ICDAS 3 and 4 lesions by comparing the sealing method with care as usual (placing a restoration).
Study objective
Dental caries lesions (with ICDAS Codes 3 and 4) can be treated by sealing, offering a less invasive and less costly treatment option with the same results as preparation and restoration of the carious lesions.
Study design
T=0: start of intervention
T=1: control after 12 months
T=2: end of the trial
Intervention
Intervention group:
cleaning occlusal surface with rotating brush pumice, isolation of tooth (rubberdam), placement of resin-based sealant after etching
Control group (care as usual)
local anesthetic, isolation (rubberdam), preparation / excavation with rotating instruments, restoration with composite resin or compomer restoration material.
J.H. Vermaire
Postbus 3005
Leiden 2301 DA
The Netherlands
088-8667876
erik.vermaire@tno.nl
J.H. Vermaire
Postbus 3005
Leiden 2301 DA
The Netherlands
088-8667876
erik.vermaire@tno.nl
Inclusion criteria
Age 3-18 years
Caries lesions in occlusal surface
Lesion stage ICDAS 3 and 4
Exclusion criteria
Under 3 years / over 17 years
Caries lesions in other surfaces
Lesion stage ICDAS 0, 1, 2, 5 and 6
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6405 |
| NTR-old | NTR6580 |
| Other | ZonMw, 's Gravenhage : 843001810 |