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Pulp Capping With Two Different Agents (MTA)

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ClinicalTrials.gov Identifier: NCT00812877
Recruitment Status : Completed
First Posted : December 22, 2008
Results First Posted : May 25, 2015
Last Update Posted : May 25, 2015
Sponsor:
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

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

Condition or disease Intervention/treatment Phase
Dental Pulp Exposure Drug: Mineral Trioxide Aggregate Drug: Calcium Hydroxide Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
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.
Study Start Date : May 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Minerals
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Pulp Vitality [ Time Frame: Up to two years ]
    No evidence of pulpal resorption or calcification or periradicular radiolucency



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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.

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

Publications of Results:
Other 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 Posted: December 22, 2008    Key Record Dates
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