The CAP-1 Trial: Stepwise Excavation Versus One Completed Excavation in Deep Caries

Not Applicable

Completed

• Conditions: Reversible Pulpitis; Dental Caries
• Interventions: Procedure: SW; Procedure: DCE

• Registration Number: NCT00187837
• Lead Sponsor: University of Copenhagen

Brief Summary

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®).

Detailed Description

References

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FOUAD AF. Molecular mediators of pulpal inflammation. In Seltzer and Bender's Dental pulp ( Hargreaves KM, Goodis HE, eds). Chicago, USA: Quintessence Publishing Co, Inc., 2002; 247-79.

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LEKSELL E, RIDELL K, CVEK M, MEJÁRE I. Pulp exposure after stepwise versus direct complete excavation of deep carious lesions in young posterior permanent teeth. Endod Dent Traumatol 1996;12:192-96.

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Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-16
• Primary Completion: 2007-03
• Study Completion: 2013-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

• Person ≥ 18 yrs having deep caries with or without pain:
• x-ray show primary caries in the inner 1/4 of the dentin, with the presence of a radiopaque zone at the pulpal wall NB: Need to mark a 'yes' for both criteria!

Exclusion Criteria

• Deep carious tooth with (irreversible pulpitis)unbearable pain and/or disturbed night's sleep)
• Deep carious tooth negatively responding on thermal and electrometric tests.
• Deep carious tooth has 'attachment loss' > 5 mm
• X-ray shows apical radiolucency of the actual tooth
• Deep carious tooth has restoration in direct contact with the pulp
• The person has problems with communication
• No informed and written consent is present
• Due to health conditions or pregnancy the person can not participate in the trial

NB: Need to mark 'No' for all criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SW intervention	SW	Stepwise Excavation
DCE intervention	DCE	Control intervention Direct complete excavation. The updated terminology for completed excavation is non-selective excavation to hard dentin

Primary Outcome Measures

Name	Time	Method
Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control.	1year control data for all treatments primo 2008	In this update we have also completed 5 yr control

Secondary Outcome Measures

Name	Time	Method
Secondary outcome constitutes pain intensity using a visual analogue scale measured before the first visit and 1 and 7 days after.	ultimo 2007

Trial Locations

Locations (1)

School of Dentistry, Faculty of Health Sciences; 🇩🇰 Copenhagen, Copenhagen N, Denmark