Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Occlusal Adjustment as Treatment for Chronic Orofacial Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Urbano Santana, University of Santiago de Compostela
ClinicalTrials.gov Identifier:
NCT00899717
First received: May 11, 2009
Last updated: July 21, 2013
Last verified: July 2013
Results First Received: April 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Temporomandibular Joint Disorders
Orofacial Pain
Interventions: Procedure: Occlusal adjustment
Procedure: Placebo occlusal adjustment

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Real Occlusal Adjustment Occlusal adjustment : modification of occlusal surfaces
Sham Occlusal Adjustment Placebo occlusal adjustment : Simulated modification of occlusal surfaces

Participant Flow:   Overall Study
    Real Occlusal Adjustment     Sham Occlusal Adjustment  
STARTED     10     11  
COMPLETED     10     11  
NOT COMPLETED     0     0  



  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
Real Occlusal Adjustment No text entered.
Sham Occlusal Adjustment No text entered.
Total Total of all reporting groups

Baseline Measures
    Real Occlusal Adjustment     Sham Occlusal Adjustment     Total  
Number of Participants  
[units: participants]
  10     11     21  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     11     21  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34.7  ± 13.7     29.73  ± 8.61     32.1  ± 11.34  
Gender  
[units: participants]
     
Female     9     8     17  
Male     1     3     4  
Region of Enrollment  
[units: participants]
     
Spain     10     11     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Analogic Scale for Pain Intensity (0-10)   [ Time Frame: Baseline, immediately after therapy, 3 months and 6 months after therapy ]

2.  Secondary:   Symptom Checklist-90-Revised (SCL-90-R®)   [ Time Frame: Before and 6 months after therapy ]

3.  Secondary:   Preferred Chewing Side   [ Time Frame: Before and 6 months after therapy ]

4.  Secondary:   Maximum Mouth Opening (mm)   [ Time Frame: 6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up ]

5.  Secondary:   Condylar Path Angles   [ Time Frame: Baseline ]


  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
No text entered.


  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: Urbano Santana Penín
Organization: University of Santiago de Compostela
phone: 0034647344093
e-mail: urbano.santana@usc.es


No publications provided


Responsible Party: Urbano Santana, University of Santiago de Compostela
ClinicalTrials.gov Identifier: NCT00899717     History of Changes
Other Study ID Numbers: 2009/017
Study First Received: May 11, 2009
Results First Received: April 10, 2013
Last Updated: July 21, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica