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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
National Health Insurance foundation
Dan Dental, Denmark
University of Aarhus
Göteborg University
Huddinge Faculty,Stockholm,Sweden
Uppsala FolkTandvård,Sweden
Malmö Dental school,Sweden
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00187850
First received: September 13, 2005
Last updated: October 2, 2009
Last verified: October 2009
History of Changes
  Purpose

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 Intervention
Dental Pulp Exposure
 Procedure: Pulp capping and partial pulpotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 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:
  • Gain of pain relief [ Time Frame: after 4 weeks ]

Estimated Enrollment: 120
Study Start Date: February 2005
Estimated Study Completion Date: December 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187850

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

No publications provided

ClinicalTrials.gov Identifier: NCT00187850     History of Changes
Other Study ID Numbers: 10002
Study First Received: September 13, 2005
Last Updated: October 2, 2009
Health Authority: Denmark: National Board of Health
Sweden: Regional Ethical Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013