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

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ClinicalTrials.gov Identifier: NCT00187837
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 18, 2016
Sponsor:
Collaborators:
National Health Insurance foundation
Dan Dental A/S
University of Aarhus
Göteborg University
Huddinge Faculty,Stockholm,Sweden
Uppsala FolkTandvård,Sweden
Malmö Dental school,Sweden
Information provided by (Responsible Party):
Lars Bjørndal, University of Copenhagen

Study Description
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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®).


Condition or disease Intervention/treatment Phase
Dental Caries Reversible Pulpitis Procedure: SW Procedure: DCE Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : February 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : June 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: SW intervention
Stepwise Excavation
 Procedure: SW
Stepwise removal of carious tissue in 2 stages
Other Name: Stepwise carious removal wos
DCE intervention
Control intervention Direct complete excavation. The updated terminology for completed excavation is non-selective excavation to hard dentin
 Procedure: DCE
one complete excavation
Other Name: Non-selective carious removal to hard dentin


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


Secondary Outcome Measures :
  1. Secondary outcome constitutes pain intensity using a visual analogue scale measured before the first visit and 1 and 7 days after. [ Time Frame: ultimo 2007 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187837


Locations
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Denmark
School of Dentistry, Faculty of Health Sciences
Copenhagen, Copenhagen N, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
National Health Insurance foundation
Dan Dental A/S
University of Aarhus
Göteborg University
Huddinge Faculty,Stockholm,Sweden
Uppsala FolkTandvård,Sweden
Malmö Dental school,Sweden
Investigators
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Study Director: Lars Bjørndal University of Copenhagen
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lars Bjørndal, PhD, Dr. Odont, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00187837    
Other Study ID Numbers: 10001
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 1½ yr results published in European Journal of Oral Sciences 2010; 118: 290-297.
Keywords provided by Lars Bjørndal, University of Copenhagen:
Stepwise excavation
Additional relevant MeSH terms:
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Dental Caries
Pulpitis
Tooth Demineralization
 Tooth Diseases
Stomatognathic Diseases
Dental Pulp Diseases