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

Study Overview
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Brief Summary
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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.

Official Title
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The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy on CAP-1 Patients: A Randomised, Patient - and Observer-Blinded Multicenter Trial

Conditions
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Dental Pulp Exposure

Intervention / Treatment
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* Procedure: PP
* Procedure: DPC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PP<br>Partial pulpotomy | Procedure: PP<br>* Partial pulpotomy<br>* Other names: cvek´s pulpotomy;|
| Other: DPC<br>Direct pulp capping | Procedure: DPC<br>* Direct pulp capping<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gain of pain relief |  | after 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulp capping, partial pulpotomy, Exposure of the pulp