The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy
NCT ID: NCT00187850
Last Updated: 2016-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2005-02-28
2013-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PP
Partial pulpotomy
PP
Partial pulpotomy
DPC
Direct pulp capping
DPC
Direct pulp capping
Interventions
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PP
Partial pulpotomy
DPC
Direct pulp capping
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Visible pus from the pulp.
18 Years
ALL
No
Sponsors
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National Health Insurance foundation
UNKNOWN
Dan Dental A/S
INDUSTRY
University of Aarhus
OTHER
Göteborg University
OTHER
Huddinge Faculty,Stockholm,Sweden
UNKNOWN
Uppsala FolkTandvård,Sweden
OTHER
Malmö Dental school,Sweden
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Lars Bjørndal
PhD, Dr.Odont
Principal Investigators
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Lars Bjørndal, Ph.D.
Role: STUDY_DIRECTOR
University of Copenhagen
Locations
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Copenhagen University
Copenhagen, Copenhagen N, Denmark
Countries
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References
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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.
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.
Other Identifiers
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10002
Identifier Type: -
Identifier Source: org_study_id
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