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Dynasplint Therapy for Trismus in Head and Neck Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507208
First Posted: July 26, 2007
Last Update Posted: September 13, 2016
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.
Collaborator:
Dynasplint Systems, Inc.
Information provided by (Responsible Party):
William Carroll, MD, University of Alabama at Birmingham
Results First Submitted: June 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Trismus
Interventions: Device: Dynasplint Trismus System
Other: Tongue Depressors

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dynasplint Participants randomized to this arm will be treated with the Dynasplint Trismus System
Control Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.

Participant Flow:   Overall Study
    Dynasplint   Control
STARTED   27   26 
Received Dynasplint in Crossover   0   3 
COMPLETED   27   26 
NOT COMPLETED   0   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 text entered.

Reporting Groups
  Description
Dynasplint Participants randomized to this arm will be treated with the Dynasplint Trismus System
Control Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
Total Total of all reporting groups

Baseline Measures
   Dynasplint   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   26   53 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   24   24   48 
>=65 years   3   2   5 
Gender 
[Units: Participants]
     
Female   9   6   15 
Male   18   20   38 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   23   17   40 
African-American   3   9   12 
Hispanic   1   0   1 
Prior Treatment [1] 
[Units: Participants]
     
Chemoradiation & Surgery   23   22   45 
Surgery only   4   4   8 
[1] Type of treatment completed prior to enrollment in the study


  Outcome Measures

1.  Primary:   Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors   [ Time Frame: 12 months ]


  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
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  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: William Carroll, MD
Organization: University of Alabama at Birmingham
phone: 205-934-9713
e-mail: wcarroll@uabmc.edu



Responsible Party: William Carroll, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00507208     History of Changes
Other Study ID Numbers: F070323014
HNO 0602 ( Other Identifier: University of Alabama at Birmingham )
First Submitted: July 25, 2007
First Posted: July 26, 2007
Results First Submitted: June 14, 2016
Results First Posted: July 25, 2016
Last Update Posted: September 13, 2016