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

Dental Pulp Exposure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187850
• Other study ID #: 10002
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 14, 2016
• Start date: February 2005
• Est. completion date: June 2013

Study information

• Verified date: October 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthSweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pulp Exposure

Intervention

Procedure:
• PP
Partial pulpotomy
• DPC
Direct pulp capping

Locations

Country	Name	City	State
Denmark	Copenhagen University	Copenhagen	Copenhagen N

Sponsors (8)

Lead Sponsor	Collaborator
University of Copenhagen	Dan Dental A/S, Göteborg University, Huddinge Faculty,Stockholm,Sweden, Malmö Dental school,Sweden, National Health Insurance foundation, University of Aarhus, Uppsala FolkTandvård,Sweden

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Bjørndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Näsman P, Thordrup M, Dige I, Nyvad B, Fransson H, Lager A, Ericson D, Petersson K, Olsson J, Santimano EM, Wennström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Gain of pain relief		after 4 weeks	No