Clinical trial NCT00187837: The CAP-1 Trial: Stepwise Excavation Versus One Completed Excavation in Deep Caries
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Reversible Pulpitis
Keywords: Stepwise excavation
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: National Health Insurance foundation
name: Dan Dental A/S
name: University of Aarhus
name: Göteborg University
name: Huddinge Faculty,Stockholm,Sweden
name: Uppsala FolkTandvård,Sweden
name: Malmö Dental school,Sweden
First posted: 2005-09-16
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®).

Detailed description: References

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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.

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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.

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LEKSELL E, RIDELL K, CVEK M, MEJÁRE I. Pulp exposure after stepwise versus direct complete excavation of deep carious lesions in young posterior permanent teeth. Endod Dent Traumatol 1996;12:192-96.

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NÄRHI M. Dentinal and pulpal pain. In Textbook of Endodontology (Bergenholtz G, Hørsted-Bindslev P, Reit C, eds). Oxford, UK: Blackwell Munksgaard, 2003; 43-56.

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Eligibility 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

Primary outcomes:
measure: Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control.
timeFrame: 1year control data for all treatments primo 2008
Secondary outcomes:
measure: Secondary outcome constitutes pain intensity using a visual analogue scale measured before the first visit and 1 and 7 days after.
timeFrame: ultimo 2007
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: School of Dentistry, Faculty of Health Sciences
state: Copenhagen N
Study officials:
affiliation: University of Copenhagen
name: Lars Bjørndal
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.