Chisel Peak Medical Centre
Invermere, British Columbia, V0A 1K0, Canada
NCT Number: NCT01706172
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 been notably helpful in preliminary studies in reducing pain and improving jaw function. This randomized trial will compare dextrose injection with sterile water injection for temporomandibular(jaw) dysfunction, also known as TMD.
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Notify Me19 year–90 year
All sexes
Interventional
Phase 2 / Phase 3
Invermere, British Columbia, V0A 1K0, Canada
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 intra-articular 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
more than 3 month history of :
Exclusion criteria
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 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
Time frame: 3 Months
TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.
Time frame: 3 Months
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
Time frame: 1 year
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
Chisel Peak Medical Clinic
Other
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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