The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy
Primary Purpose
Dental Pulp Exposure
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PP
DPC
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pulp Exposure focused on measuring Pulp capping, partial pulpotomy, Exposure of the pulp
Eligibility 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.
Sites / Locations
- Copenhagen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
PP
DPC
Arm Description
Partial pulpotomy
Direct pulp capping
Outcomes
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.
Secondary Outcome Measures
Gain of pain relief
Full Information
NCT ID
NCT00187850
First Posted
September 13, 2005
Last Updated
October 14, 2016
Sponsor
University of Copenhagen
Collaborators
National Health Insurance foundation, Dan Dental A/S, University of Aarhus, Göteborg University, Huddinge Faculty,Stockholm,Sweden, Uppsala FolkTandvård,Sweden, Malmö Dental school,Sweden
1. Study Identification
Unique Protocol Identification Number
NCT00187850
Brief Title
The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
National Health Insurance foundation, Dan Dental A/S, University of Aarhus, Göteborg University, Huddinge Faculty,Stockholm,Sweden, Uppsala FolkTandvård,Sweden, Malmö Dental school,Sweden
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Exposure
Keywords
Pulp capping, partial pulpotomy, Exposure of the pulp
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PP
Arm Type
Experimental
Arm Description
Partial pulpotomy
Arm Title
DPC
Arm Type
Other
Arm Description
Direct pulp capping
Intervention Type
Procedure
Intervention Name(s)
PP
Other Intervention Name(s)
cvek´s pulpotomy
Intervention Description
Partial pulpotomy
Intervention Type
Procedure
Intervention Name(s)
DPC
Intervention Description
Direct pulp capping
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Gain of pain relief
Time Frame
after 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Bjørndal, Ph.D.
Organizational Affiliation
University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Copenhagen University
City
Copenhagen
State/Province
Copenhagen N
ZIP/Postal Code
2200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
20572864
Citation
Bjorndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Thordrup M, Dige I, Nyvad B, Fransson H, Lager A, Ericson D, Petersson K, Olsson J, Santimano EM, Wennstrom A, Winkel P, Gluud C. Treatment of deep caries lesions in adults: randomized clinical trials comparing stepwise vs. direct complete excavation, and direct pulp capping vs. partial pulpotomy. Eur J Oral Sci. 2010 Jun;118(3):290-7. doi: 10.1111/j.1600-0722.2010.00731.x.
Results Reference
background
PubMed Identifier
28410008
Citation
Bjorndal L, Fransson H, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Hedenbjork-Lager A, Dige I, Thordrup M. Randomized Clinical Trials on Deep Carious Lesions: 5-Year Follow-up. J Dent Res. 2017 Jul;96(7):747-753. doi: 10.1177/0022034517702620. Epub 2017 Apr 14.
Results Reference
derived
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The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy
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