The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy

Not Applicable

Completed

• Conditions: Dental Pulp Exposure
• Interventions: Procedure: PP; Procedure: DPC

• Registration Number: NCT00187850
• Lead Sponsor: University of Copenhagen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2007-03
• Study Completion: 2013-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Persons participating in the CAP-1 trial, who have received a pulp exposure due to treatment or due to absence of pain relief.

Exclusion Criteria

• The CAP-1-treated tooth has ongoing unbearable pain and/or disturbed night sleep.
• Visible pus from the pulp.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PP	PP	Partial pulpotomy
DPC	DPC	Direct pulp capping

Primary Outcome Measures

Name	Time	Method
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.	1 year after inclusion in the CAP-2

Secondary Outcome Measures

Name	Time	Method
Gain of pain relief	after 4 weeks

Trial Locations

Locations (1)

Copenhagen University; 🇩🇰 Copenhagen, Copenhagen N, Denmark