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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 s

Detailed Summary:

References

BJERKÉN E, WENNBERG A, TRONSTAD L. Endodontisk akutbehandling. Tandläkartidningen. 1980;72:314-9.

BJØRNDAL L, REIT C. The annual frequency of root-fillings, tooth extractions and pulp related procedures in Danish adults 1977-2003. Int Endod J 2004:37:782-788.

BJØRNDAL L. The deep caries lesion dilemma. In Nordic Dentistry 2004 yearbook (Schou L, ed). Copenhagen, Denmark: Quintessence Publishing Co, Inc., 2004; 107-20.

BJØRNDAL L & THYLSTRUP A. A practice -based study on stepwise excavation of deep carious lesions in permanent teeth: a 1-year follow-up study. Community Dent Oral Epidemiol 1998;26:122-8.

BJØRNDAL L. Treatment of deep carious lesions with stepwise excavation. A practice-based study. Tandlaegebladet 1999;103:498-506.

BJØRNDAL L, LARSEN T, THYLSTRUP A. A clinical and microbiological study of deep carious lesions during stepwise excavation using long treatment intervals. Caries Res 1997;31:411-.

BJØRNDAL L, LARSEN T. Changes in the cultivable flora in deep carious lesions following a stepwise excavation procedure. Caries Res 2000;34:502-8.

BERGENHOLTZ G, SPÅNGBERG L. Controversies in endodontics. Crit Rev Oral Biol Med 2004;15:99-114.

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.

KARLSSON P-O, REIT C. Reasons for endodontic
Sponsor: University of Copenhagen

Current Primary Outcome: 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


Original Primary Outcome: Primary outcome is whether the treatment can be made with a mainiained sensible pulp and without root infection following a 1-year control.

Current Secondary Outcome: 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 ]

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

Information By: University of Copenhagen

Dates:
Date Received: September 9, 2005
Date Started: February 2005
Date Completion:
Last Updated: October 14, 2016
Last Verified: October 2016