Pulp Capping With Two Different Agents (MTA)

This study has been completed.
Sponsor:
Collaborators:
University of Washington
Information provided by (Responsible Party):
Thomas J. Hilton, DMD, MS, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00812877
First received: December 18, 2008
Last updated: May 3, 2015
Last verified: May 2015
  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 ]
    No recommendation for tooth extraction or root canal therapy. Only one tooth was enrolled/assessed per participant.


Secondary Outcome Measures:
  • Pulp Vitality [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
    No evidence of pulpal resorption or calcification or periradicular radiolucency


Enrollment: 376
Study Start Date: May 2009
Study Completion Date: May 2012
Primary Completion Date: May 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:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Any patient 7 years old or older 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.
  5. Non-English and/or non-Spanish speaking subjects.
  Contacts and Locations
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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
University of Washington
Investigators
Principal Investigator: Thomas Hilton, DMD, MS NW PRECEDENT
  More Information

Publications:
Responsible Party: Thomas J. Hilton, DMD, MS, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00812877     History of Changes
Other Study ID Numbers: NIDCR-16752, U01DE016750
Study First Received: December 18, 2008
Results First Received: August 15, 2013
Last Updated: May 3, 2015
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 July 01, 2015