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

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

Interventions

PROCEDURE

SW

Stepwise removal of carious tissue in 2 stages

PROCEDURE

DCE

one complete excavation

Sponsors & Collaborators

• National Health Insurance foundation

  collaborator UNKNOWN

• Dan Dental A/S

  collaborator INDUSTRY

• University of Aarhus

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Huddinge Faculty,Stockholm,Sweden

  collaborator UNKNOWN

• Uppsala FolkTandvård,Sweden

  collaborator OTHER

• Malmö Dental school,Sweden

  collaborator UNKNOWN

• University of Copenhagen

  lead OTHER

Principal Investigators

• Lars Bjørndal · University of Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-02-28

Primary Completion

2007-03-31

Completion

2013-06-30

Countries

• Denmark

Study Locations