Dental Caries Clinical Trial
Official title:
The CAP-1 Trial: Effect of Stepwise Versus One Completed Excavation in Deep Caries in Permanent Teeth: A Randomised, Patient - and Observer-blinded Multicenter Trial
Brief summary
Background:
A large proportion of dental practice involves the treatment of caries in the permanent
dentition. In USA alone tooth related pain is annually responsible for 15 billions days lost
through sickness. We do not know whether a stepwise excavation is better or worse compared
with one final completed excavation in adults with deep caries with or without pain. A deep
carious lesion is in the risk zone of being pulpal exposed during excavation.
Aim:
The aim of the CAP-1-trial is to investigate the beneficial effects of stepwise excavation
during two visits versus óne completed excavation of deep caries in permanent teeth with or
without pain.
Patients:
Consecutive patients contacting the units involved in the CAP trial for the treatment of
deep caries. The trial will comprise 300 patients.
Design:
CAP-1-trial is a randomised patient- and observer-blinded multicenter trial, with two
parallel intervention groups. Patients that fulfill the inclusions criteria and none of the
exclusions criteria, will be centrally bloc-randomised in Copenhagen Trial Unit, Copenhagen
DK, and stratified by age and pain. Allocation ratio is 1:1.
Interventions and products:
Patients are allocated for stepwise excavation in two visits or final excavation in one
visit. The patients will not be informed about the result of the randomisation, i.e. the
type of intervention. Therefore, all patients will be contacted for two visits. The second
visit in the stepwise excavation group wil be used for the second and final excavation, and
for the performance of a permanent restoration. The second visit in the one step excavation
group will solely be used for the performance of a permanent restoration. The interventions
in both groups are completed following 8-10 weeks after the randomisation.
A temporary calcium hydroxide based material is used in both groups (Dycal®). The temporary
restoration material, glas-ionomer cement is used (Ketac Molar®) in between visits, and a
resin material is used for the final restoration(Herculite®).
References
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BJØRNDAL L, REIT C. The annual frequency of root-fillings, tooth extractions and pulp
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BJØRNDAL L & THYLSTRUP A. A practice -based study on stepwise excavation of deep carious
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BJØRNDAL L. Treatment of deep carious lesions with stepwise excavation. A practice-based
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BJØRNDAL L, LARSEN T. Changes in the cultivable flora in deep carious lesions following a
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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