Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

Chisel Peak Medical Clinic

Status and phase: Completed; Phase 3; Phase 2

Conditions: Temporomandibular Joint Disorders

Treatments: Other: Injection of 20% dextrose/ 0.2% lidocaine; Other: Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01706172

TMJS

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 42 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

more than 3 month history of :

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

Dextrose 20 % Injection

Active Comparator group

Description:

Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint

Treatment:

Other: Injection of 20% dextrose/ 0.2% lidocaine

Sterile Water Injection

Active Comparator group

Description:

Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint

Treatment:

Other: Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine