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Pulp Capping With Two Different Agents (MTA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00812877
First Posted: December 22, 2008
Last Update Posted: May 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Washington
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Thomas J. Hilton, DMD, MS, Oregon Health and Science University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Thomas J. Hilton, DMD, MS, Oregon Health and Science University:

Primary Outcome Measures:
  • Tooth Survival [ Time Frame: Up to two years ]
    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 ]
    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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Dental and Craniofacial Research (NIDCR)
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 ( U.S. NIH Grant/Contract )
First Submitted: December 18, 2008
First Posted: December 22, 2008
Results First Submitted: August 15, 2013
Results First Posted: May 25, 2015
Last Update Posted: May 25, 2015
Last Verified: May 2015

Keywords provided by Thomas J. Hilton, DMD, MS, Oregon Health and Science University:
pulp capping
MTA
CaOH
Mineral Trioxide Aggregate
Calcium Hydroxide

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