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

Purpose

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	Intervention
Deep Caries Lesions Reversible Pulpitis	Procedure: Stepwise Excavation, one completed excavation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	300
Study Start Date:	February 2005
Estimated Study Completion Date:	February 2008

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187837

Locations


Denmark, Copenhagen N
	School of Dentistry, Faculty of Health Sciences
	Copenhagen, Copenhagen N, Denmark, 2200

Sponsors and Collaborators

University of Copenhagen

National Health Insurance foundation

Dan Dental, Denmark

University of Aarhus

Gothenborg University,Sweden

Huddinge Faculty,Stockholm,Sweden

Uppsala FolkTandvård,Sweden

Malmö Dental school,Sweden

Investigators


Study Director:	Lars Bjørndal	University of Copenhagen

More Information

Study ID Numbers:	10001
First Received:	September 9, 2005
Last Updated:	May 7, 2007
ClinicalTrials.gov Identifier:	NCT00187837
Health Authority:	Denmark: National Board of Health; Sweden: Regional Ethical Review Board

Keywords provided by University of Copenhagen:

Stepwise excavation

Study placed in the following topic categories:

Tooth Diseases

Dental Pulp Diseases

Stomatognathic Diseases

Pulpitis

Dental Caries

Additional relevant MeSH terms:

Tooth Demineralization

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	University of Copenhagen National Health Insurance foundation Dan Dental, Denmark University of Aarhus Gothenborg University,Sweden Huddinge Faculty,Stockholm,Sweden Uppsala FolkTandvård,Sweden Malmö Dental school,Sweden
Information provided by:	University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00187837