Trial record 9 of 16 for:    "familial cold autoinflammatory syndrome" OR "Familial Cold Autoinflammatory Syndrome"

The CAP-1 Trial: Stepwise Excavation Versus One Completed Excavation in Deep Caries

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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:
NCT00187837
First received: September 9, 2005
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

Brief summary

Background:

A large proportion of dental practice involves the treatment of caries in the permanent dentition. In USA alone tooth related pain is annually responsible for 15 billions days lost through sickness. We do not know whether a stepwise excavation is better or worse compared with one final completed excavation in adults with deep caries with or without pain. A deep carious lesion is in the risk zone of being pulpal exposed during excavation.

Aim:

The aim of the CAP-1-trial is to investigate the beneficial effects of stepwise excavation during two visits versus óne completed excavation of deep caries in permanent teeth with or without pain.

Patients:

Consecutive patients contacting the units involved in the CAP trial for the treatment of deep caries. The trial will comprise 300 patients.

Design:

CAP-1-trial is a randomised patient- and observer-blinded multicenter trial, with two parallel intervention groups. Patients that fulfill the inclusions criteria and none of the exclusions criteria, will be centrally bloc-randomised in Copenhagen Trial Unit, Copenhagen DK, and stratified by age and pain. Allocation ratio is 1:1.

Interventions and products:

Patients are allocated for stepwise excavation in two visits or final excavation in one visit. The patients will not be informed about the result of the randomisation, i.e. the type of intervention. Therefore, all patients will be contacted for two visits. The second visit in the stepwise excavation group wil be used for the second and final excavation, and for the performance of a permanent restoration. The second visit in the one step excavation group will solely be used for the performance of a permanent restoration. The interventions in both groups are completed following 8-10 weeks after the randomisation.

A temporary calcium hydroxide based material is used in both groups (Dycal®). The temporary restoration material, glas-ionomer cement is used (Ketac Molar®) in between visits, and a resin material is used for the final restoration(Herculite®).


Condition Intervention
Deep Caries Lesions
Reversible Pulpitis
Procedure: Stepwise Excavation, one completed excavation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The CAP-1 Trial: Effect of Stepwise Versus One Completed Excavation in Deep Caries in Permanent Teeth: A Randomised, Patient - and Observer-blinded Multicenter Trial

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control. [ Time Frame: 1year control data for all treatments primo 2008 ]

Secondary Outcome Measures:
  • Secondary outcome constitutes pain intensity using a visual analogue scale measured before the first visit and 1 and 7 days after. [ Time Frame: ultimo 2007 ]

Enrollment: 314
Study Start Date: February 2005
Estimated Study Completion Date: December 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Person ≥ 18 yrs having deep caries with or without pain:
  • x-ray show primary caries in the inner 1/4 of the dentin, with the presence of a radiopaque zone at the pulpal wall NB: Need to mark a 'yes' for both criteria!

Exclusion Criteria:

  • Deep carious tooth with (irreversible pulpitis)unbearable pain and/or disturbed night's sleep)
  • Deep carious tooth negatively responding on thermal and electrometric tests.
  • Deep carious tooth has 'attachment loss' > 5 mm
  • X-ray shows apical radiolucency of the actual tooth
  • Deep carious tooth has restoration in direct contact with the pulp
  • The person has problems with communication
  • No informed and written consent is present
  • Due to health conditions or pregnancy the person can not participate in the trial

NB: Need to mark 'No' for all criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187837

Locations
Denmark
School of Dentistry, Faculty of Health Sciences
Copenhagen, Copenhagen N, Denmark, 2200
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
Investigators
Study Director: Lars Bjørndal University of Copenhagen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00187837     History of Changes
Other Study ID Numbers: 10001
Study First Received: September 9, 2005
Last Updated: October 2, 2009
Health Authority: Denmark: National Board of Health
Sweden: Regional Ethical Review Board

Keywords provided by University of Copenhagen:
Stepwise excavation

Additional relevant MeSH terms:
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 29, 2014