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Dynasplint Therapy for Trismus in Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
Dynasplint Systems, Inc.
Information provided by (Responsible Party):
William Carroll, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00507208
First received: July 25, 2007
Last updated: August 1, 2016
Last verified: August 2016
Results First Received: June 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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  
Number of Participants  
[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 )
Study First Received: July 25, 2007
Results First Received: June 14, 2016
Last Updated: August 1, 2016
Health Authority: United States: Institutional Review Board