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

NCT00187837 | Completed DMC

• 1 other identifier: 10001
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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®).

Conditions

Dental Caries; Reversible Pulpitis

Keywords

Stepwise excavation

Outcome Measures

Primary Outcomes (1)

• Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control.

  In this update we have also completed 5 yr control

  1year control data for all treatments primo 2008

Secondary Outcomes (1)

• Secondary outcome constitutes pain intensity using a visual analogue scale measured before the first visit and 1 and 7 days after.

  ultimo 2007

Study Arms (2)

SW intervention

EXPERIMENTAL

Stepwise Excavation

Procedure: SW

DCE intervention

OTHER

Control intervention Direct complete excavation. The updated terminology for completed excavation is non-selective excavation to hard dentin

Procedure: DCE

Interventions

SW PROCEDURE

Stepwise removal of carious tissue in 2 stages

Also known as: Stepwise carious removal wos

SW intervention

DCE PROCEDURE

one complete excavation

Also known as: Non-selective carious removal to hard dentin

DCE intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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!

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• National Health Insurance foundation: collaborator
• Dan Dental A/S: collaborator
• University of Aarhus: collaborator
• Göteborg University: collaborator
• Huddinge Faculty,Stockholm,Sweden: collaborator
• Uppsala FolkTandvård,Sweden: collaborator
• Malmö Dental school,Sweden: collaborator

Study Sites (1)

School of Dentistry, Faculty of Health Sciences

Copenhagen, Copenhagen N, 2200, Denmark

Location

Related Publications (2)

• Bjorndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Thordrup M, Dige I, Nyvad B, Fransson H, Lager A, Ericson D, Petersson K, Olsson J, Santimano EM, Wennstrom A, Winkel P, Gluud C. Treatment of deep caries lesions in adults: randomized clinical trials comparing stepwise vs. direct complete excavation, and direct pulp capping vs. partial pulpotomy. Eur J Oral Sci. 2010 Jun;118(3):290-7. doi: 10.1111/j.1600-0722.2010.00731.x.

  PMID: 20572864 RESULT

• Bjorndal L, Fransson H, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Hedenbjork-Lager A, Dige I, Thordrup M. Randomized Clinical Trials on Deep Carious Lesions: 5-Year Follow-up. J Dent Res. 2017 Jul;96(7):747-753. doi: 10.1177/0022034517702620. Epub 2017 Apr 14.

  PMID: 28410008 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Lars Bjørndal

  University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Dr. Odont

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Study Start: February 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: June 1, 2013
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)