An interventional study of PP and DPC in Dental Pulp Exposure, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-18.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Treatment
CAP-2 Trial
Background: This trial is being done in conjunction with an ongoing clinical trial investigating stepwise excavation versus final excavation on deep caries lesions (The CAP-1 trial). The investigators lack systematic knowledge concerning the treatment of the exposed pulp and whether the capping of a pulp represents the same outcome as the partial removal of an additional 1-1.5 mm of the pulp tissue (partial pulpotomy).
Aim: The aim of the CAP-2 trial is in a randomised clinical trial to investigate the effect of direct pulp capping versus partial pulpotomy in patients who, from the beginning, have received either a final excavation or a stepwise excavation and where this intervention has led to the exposure of a vital pulp and/or the patient has not gained relief from tooth pain after excavation and placement of a temporary restoration.
Patients: Patients include consecutive patients with deep caries who have been participating in the CAP-1 trial, where the pulp exposure to a bleeding pulp is present and/or pain relief has not been obtained.
Design: The CAP-2 trial is a randomised patient- and observer-blinded multicenter trial, with two parallel intervention groups. Patients who fulfill the inclusion criteria will be centrally bloc-randomised in the Copenhagen Trial Unit, Copenhagen DK, and stratified by age and pain. The allocation ratio is 1:1.
The Interventions and Products: Patients are allocated for direct pulp capping or partial pulpotomy. The patients will not be informed about the results of the randomisation, i.e. the type of intervention. In both groups the patient receives a calcium hydroxide seal covering the exposure and a glass ionomer restoration. The final resin restoration is placed following 4 weeks.
29 studies on the registry are indexed under Dental Pulp Exposure; 5 are open to participants now.
This study's planned enrollment of 120 is above the median of 53 across 27 interventional studies indexed under Dental Pulp Exposure.
Browse Dental Pulp Exposure studies →University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Partial pulpotomy
Procedure: PP
Direct pulp capping
Procedure: DPC
Partial pulpotomy
Also known as: cvek´s pulpotomy
Direct pulp capping
The survival of the tooth with vital pulp and without apical radiolucency. The x-ray evaluation and the clinical sensibility test are carried out by a blinded observer.
Time frame: 1 year after inclusion in the CAP-2
Gain of pain relief
Time frame: after 4 weeks
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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University of Copenhagen