Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
|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.|
|ClinicalTrials.gov Identifier: NCT01617356|
Recruitment Status : Unknown
Verified March 2015 by Ricardo D Frusso, M.D., Frusso, Ricardo, M.D..
Recruitment status was: Enrolling by invitation
First Posted : June 12, 2012
Last Update Posted : March 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Temporomandibular Joint Disorders||Other: Injection of 20% dextrose/ 0.2% lidocaine Other: Injection of 1 ml of 0.8 SW/0.2% lidocaine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
|Active Comparator: Dextrose Injection||
Other: Injection of 20% dextrose/ 0.2% lidocaine
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.
|Active Comparator: Sterile Water Injection||
Other: Injection of 1 ml of 0.8 SW/0.2% lidocaine
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine.
- Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain [ Time Frame: 3 Months ]TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.
- Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction. [ Time Frame: 3 Months ]Description: TMJ injection of 20% dextrose will result in significantly more improvement in Jaw Dysfunction at 3 months. Jaw dysfunction is rated based on the worst of the following: Chewing difficulty, jaw tension or stiffness, fatigue with eating, or grinding noises
- Long term change from baseline in Numerical Rating Scale (NRS) for Jaw Pain [ Time Frame: 1 year ]TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617356
|Hospital Italiano de Buenos Aires|
|Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1181|
|Principal Investigator:||Ricardo D Frusso, M.D.||Hospital Italiano de Buenos Aires|