Pulp Capping With Two Different Agents (MTA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00812877
First received: December 18, 2008
Last updated: June 29, 2011
Last verified: September 2009
  Purpose

The purpose of this study is to determine if MTA or calcium hydroxide are more effective as pulp capping agents


Condition Intervention
Dental Pulp Exposure
Drug: Mineral Trioxide Aggregate
Drug: Calcium Hydroxide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mineral Trioxide Aggregate (MTA) vs. Calcium Hydroxide (CaOH) in Direct Pulp Capping in NW PRECEDENT (Northwest Practice-based REsearch Collaborative in Evidence-based DENTistry Practices.

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Tooth Survival [ Time Frame: Up to two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulp vitality [ Time Frame: Up to two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 640
Study Start Date: May 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mineral Trioxide Aggregate
Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
Drug: Mineral Trioxide Aggregate
Pulp capping agent, Mineral TrioxideAggregate
Other Name: MTA
Active Comparator: Calcium Hydroxide
Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
Drug: Calcium Hydroxide
Pulp capping agent, Calcium Hydroxide
Other Name: Calcium Hydroxide

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Any patient less than 7 years old who requires a direct pulp cap of a permanent tooth.
  2. The tooth must exhibit a vital pulp upon exposure.
  3. The exposure can be due to mechanical, traumatic or carious causes.
  4. Patient will be available for the two year follow-up period.

Exclusion Criteria:

  1. Any primary tooth requiring a direct pulp cap.
  2. Tooth demonstrates any radicular radiolucency on a radiograph.
  3. Tooth exhibits spontaneous pain.
  4. Tooth exhibits lingering (more than 5 seconds) pain to temperature or biting stimulus.
  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: NCT00812877

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Thomas Hilton, DMD, MS NW PRECEDENT
  More Information

No publications provided

Responsible Party: Thomas Hilton, DMD, MS (PI), Oregon Health & Science University, Portland, OR
ClinicalTrials.gov Identifier: NCT00812877     History of Changes
Other Study ID Numbers: NIDCR-16752
Study First Received: December 18, 2008
Last Updated: June 29, 2011
Health Authority: United States: Federal Government

Keywords provided by Oregon Health and Science University:
pulp capping
MTA
CaOH
Mineral Trioxide Aggregate
Calcium Hydroxide

Additional relevant MeSH terms:
Dental Pulp Exposure
Dental Pulp Diseases
Stomatognathic Diseases
Tooth Diseases
Calcium, Dietary
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014