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

Sponsor
University of Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT00187850
Collaborator
National Health Insurance foundation (Other), Dan Dental A/S (Industry), University of Aarhus (Other), Göteborg University (Other), Huddinge Faculty,Stockholm,Sweden (Other), Uppsala FolkTandvård,Sweden (Other), Malmö Dental school,Sweden (Other)
120
Enrollment
1
Location
2
Arms
99.9
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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 Phase
  • Procedure: PP
  • Procedure: DPC
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2005
Actual Primary Completion Date :
Mar 1, 2007
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: PP

Partial pulpotomy

Procedure: PP
Partial pulpotomy
Other Names:
  • cvek´s pulpotomy

    		•
    Other: DPC

    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. [1 year after inclusion in the CAP-2]

    Secondary Outcome Measures

    1. Gain of pain relief [after 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 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

    Investigators

    • Study Director: Lars Bjørndal, Ph.D., University of Copenhagen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lars Bjørndal, PhD, Dr.Odont, University of Copenhagen
    ClinicalTrials.gov Identifier:
    NCT00187850
    Other Study ID Numbers:
    • 10002
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Oct 18, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Lars Bjørndal, PhD, Dr.Odont, University of Copenhagen
    Pulp capping
    partial pulpotomy
    Exposure of the pulp
    Additional relevant MeSH terms:
    Dental Pulp Exposure

    Study Results

    No Results Posted as of Oct 18, 2016