Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pulp Capping With Two Different Agents (MTA)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00812877
First received: December 18, 2008
Last updated: May 3, 2015
Last verified: May 2015
Results First Received: August 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Dental Pulp Exposure
Interventions: Drug: Mineral Trioxide Aggregate
Drug: Calcium Hydroxide

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty-five dental practices recruited and enrolled subjects between May 2009 and March 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was done on a practice level rather than a patient level. The handling characteristics of the two materials were so dissimilar that it was not feasible to blind the practitioners as to which material they were using.

Reporting Groups
  Description
Mineral Trioxide Aggregate Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
Calcium Hydroxide Pulp capping agent, Calcium Hydroxide used as a direct pulp cap

Participant Flow:   Overall Study
    Mineral Trioxide Aggregate     Calcium Hydroxide  
STARTED     195     181  
COMPLETED     158     130  
NOT COMPLETED     37     51  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mineral Trioxide Aggregate Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
Calcium Hydroxide Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
Total Total of all reporting groups

Baseline Measures
    Mineral Trioxide Aggregate     Calcium Hydroxide     Total  
Number of Participants  
[units: participants]
  195     181     376  
Age  
[units: participants]
     
<=18 years     34     31     65  
Between 18 and 65 years     147     138     285  
>=65 years     14     12     26  
Age  
[units: years]
Mean (Standard Deviation)
  38.5  (18.6)     36.3  (18.0)     37.5  (18.3)  
Gender  
[units: participants]
     
Female     97     94     191  
Male     98     87     185  
Region of Enrollment  
[units: participants]
     
United States     195     181     376  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tooth Survival   [ Time Frame: Up to two years ]

2.  Secondary:   Pulp Vitality   [ Time Frame: Up to two years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  1. Randomization was by practice therefore, some dentists may have used a material with which they had little familiarity.
  2. Lack of on-going monitoring of study procedures may have caused an inordinate number of failures in one practice.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Thomas J. Hilton
Organization: Oregon Health & Science University
phone: 503.494.8672
e-mail: hiltont@ohsu.edu


Publications of Results:
Other Publications:

Responsible Party: Thomas J. Hilton, DMD, MS, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00812877     History of Changes
Other Study ID Numbers: NIDCR-16752
U01DE016750 ( US NIH Grant/Contract Award Number )
Study First Received: December 18, 2008
Results First Received: August 15, 2013
Last Updated: May 3, 2015
Health Authority: United States: Federal Government