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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01567839
First Posted: March 30, 2012
Last Update Posted: January 1, 2014
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.
Information provided by (Responsible Party):
John Nusstein, Ohio State University
Results First Submitted: June 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, 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
  Description
Subjects Receiving Injections All subjects received each of the three anesthetic injections.

Participant Flow:   Overall Study
    Subjects Receiving Injections
STARTED   60 
COMPLETED   60 
NOT COMPLETED   0 



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

Baseline Measures
   Subjects Receiving Injections 
Overall Participants Analyzed 
[Units: Participants]
 60 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   60 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 25.8  (2.5) 
Gender 
[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
e-mail: nusstein.1@osu.edu


Publications:

Responsible Party: John Nusstein, Ohio State University
ClinicalTrials.gov Identifier: NCT01567839     History of Changes
Other Study ID Numbers: 4% dental local anesthetics
First Submitted: March 28, 2012
First Posted: March 30, 2012
Results First Submitted: June 24, 2013
Results First Posted: January 1, 2014
Last Update Posted: January 1, 2014