Home
Search
Study Topics
Glossary
|
|
|
|
|
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 |
---|---|
Information provided by: | University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT00187850 |
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: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 120 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lars Bjørndal, Ph.D. | +45 35326814 | lb@odont.ku.dk |
Contact: Claes Reit, Dr. Odont. | +46 317733257 | reit@odontolgi.gu.se |
Denmark, Copenhagen N | |
Copenhagen University | Recruiting |
Copenhagen, Copenhagen N, Denmark, 2200 | |
Contact: Lars Bjørndal +45 35326814 lb@odont.ku.dk | |
Contact: Gitte Bruun +45 35326811 gitte@odont.ku.dk | |
Sub-Investigator: Laila Johannesen, Ph.D. |
Study Director: | Lars Bjørndal, Ph.D. | University of Copenhagen |
Study ID Numbers: | 10002 |
Study First Received: | September 13, 2005 |
Last Updated: | September 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00187850 History of Changes |
Health Authority: | Denmark: National Board of Health; Sweden: Regional Ethical Review Board |
Pulp capping partial pulpotomy Exposure of the pulp |
Tooth Diseases Dental Pulp Exposure Dental Pulp Diseases Stomatognathic Diseases |
Tooth Diseases Dental Pulp Exposure Dental Pulp Diseases Stomatognathic Diseases |