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

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.

Conditions

• Dental Pulp Exposure

Interventions

PROCEDURE

PP

Partial pulpotomy

PROCEDURE

DPC

Direct pulp capping

Sponsors & Collaborators

• National Health Insurance foundation

  collaborator UNKNOWN

• Dan Dental A/S

  collaborator INDUSTRY

• University of Aarhus

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Huddinge Faculty,Stockholm,Sweden

  collaborator UNKNOWN

• Uppsala FolkTandvård,Sweden

  collaborator OTHER

• Malmö Dental school,Sweden

  collaborator UNKNOWN

• University of Copenhagen

  lead OTHER

Principal Investigators

• Lars Bjørndal, Ph.D. · University of Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-02-28

Primary Completion

2007-03-31

Completion

2013-06-30

Countries

• Denmark

Study Locations