Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
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Purpose
Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be quite long lasting and debilitating. Dextrose injection with a small needle has be notably helpful in preliminary studies in reducing pain and improving jaw function. This randomized trial will compare dextrose injection with saline injection for temporomandibular(jaw) dysfunction, also known as TMD.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy |
- Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain [ Time Frame: 3 Months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
| Estimated Enrollment: | 42 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of symptom diminishment, especially in the elderly. However studies out to 2-8 years show residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been utilized empirically for many years and a marked reduction in pain and luxation after intraarticular and pericapsular dextrose injection has been reported in a recent RCT. However, small study size and lack of a non injection control have prevented any definitive conclusions as the additional efficacy of including dextrose in the injectate. The mechanism of action of dextrose injection was originally thought to be via a brief stimulation of the inflammatory cascade with resultant production of growth factors. However, non-inflammatory dextrose effects on growth factor production have been demonstrated, and, more recently, dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). This has the theoretical benefit of reducing pain, regardless of the status and position of the intraarticular cartilage or degree of degenerative change of the TMD. The primary goal of this study is to evaluate the ability of dextrose injection versus saline injection to reduce pain and improve functional complaints referable to the temporomandibular joint.
Eligibility| Ages Eligible for Study: | 19 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Facial Pain NRS rating > 5/10
- Jaw symptom rating > 5/10
- Jaw function issues seen on examination
Exclusion Criteria:
- Any potential acute dental issue
- Rheumatic inflammatory disease
- Chronic intake of NSAIDs or corticosteroids.
- Pain in other body location worse than jaw pain
- Pain 10/10 in other body location.
Contacts and Locations| Argentina | |
| 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 |
More Information
No publications provided
| Responsible Party: | Ricardo D Frusso, M.D., Principal Investigator, Frusso, Ricardo, M.D. |
| ClinicalTrials.gov Identifier: | NCT01617356 History of Changes |
| Other Study ID Numbers: | Buenos Aires 1969 |
| Study First Received: | June 5, 2012 |
| Last Updated: | August 16, 2012 |
| Health Authority: | Argentina: Human Research Bioethics Committee |
Keywords provided by Frusso, Ricardo, M.D.:
|
TMD temporomandibular dextrose prolotherapy |
Additional relevant MeSH terms:
|
Joint Diseases Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Musculoskeletal Diseases Craniomandibular Disorders Mandibular Diseases Jaw Diseases Muscular Diseases Stomatognathic Diseases Myofascial Pain Syndromes Lidocaine |
Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013