Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Testing the Anesthetic Effectiveness of Three Different Dental Local Anesthetics Injected Next to a Lower First Molar

This study has been completed.
Information provided by (Responsible Party):
John Nusstein, Ohio State University Identifier:
First received: March 28, 2012
Last updated: November 7, 2013
Last verified: November 2013
Results First Received: June 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Condition: Anesthetic Effectiveness
Intervention: Procedure: Mandibular buccal Infiltration injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment at the College of Dentistry between May 2012 and December 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No exclusions. All subjects enrolled were utilized and assigned.

Reporting Groups
Subjects Receiving Injections All subjects received each of the three anesthetic injections.

Participant Flow:   Overall Study
    Subjects Receiving Injections  
STARTED     60  
COMPLETED     60  

  Baseline Characteristics
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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 difference.

Reporting Groups
Subjects Receiving Injections All subjects received each of the three anesthetic injections.

Baseline Measures
    Subjects Receiving Injections  
Number of Participants  
[units: participants]
[units: participants]
<=18 years     0  
Between 18 and 65 years     60  
>=65 years     0  
[units: years]
Mean ± Standard Deviation
  25.8  ± 2.5  
[units: participants]
Female     30  
Male     30  
Region of Enrollment  
[units: participants]
United States     60  

  Outcome Measures

1.  Primary:   Successful Pulpal Anesthesia.   [ Time Frame: 60 minutes ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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
No adverse events.

  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. John Nusstein
Organization: The Ohio State University, Division of Endodontics
phone: 614-292-9412


Responsible Party: John Nusstein, Ohio State University Identifier: NCT01567839     History of Changes
Other Study ID Numbers: 4% dental local anesthetics
Study First Received: March 28, 2012
Results First Received: June 24, 2013
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board