We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00187850
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 18, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Dental Pulp Exposure Procedure: PP Procedure: DPC

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy on CAP-1 Patients: A Randomised, Patient - and Observer-Blinded Multicenter Trial
Study Start Date : February 2005
Primary Completion Date : March 2007
Study Completion Date : June 2013

Arms and Interventions

Arm Intervention/treatment
Experimental: PP
Partial pulpotomy
Procedure: PP
Partial pulpotomy
Other Name: cvek´s pulpotomy
Direct pulp capping
Procedure: DPC
Direct pulp capping

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Gain of pain relief [ Time Frame: after 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187850

Copenhagen University
Copenhagen, Copenhagen N, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
National Health Insurance foundation
Dan Dental A/S
University of Aarhus
Göteborg University
Huddinge Faculty,Stockholm,Sweden
Uppsala FolkTandvård,Sweden
Malmö Dental school,Sweden
Study Director: Lars Bjørndal, Ph.D. University of Copenhagen
More Information

Responsible Party: Lars Bjørndal, PhD, Dr.Odont, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00187850     History of Changes
Other Study ID Numbers: 10002
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Lars Bjørndal, University of Copenhagen:
Pulp capping
partial pulpotomy
Exposure of the pulp

Additional relevant MeSH terms:
Dental Pulp Exposure
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases