Overview

This trial is active, not recruiting.

Condition temporomandibular joint disorders
Treatments injection of 20% dextrose/ 0.2% lidocaine, injection of 1 ml of 0.8 sterile water /0.2% lidocaine
Phase phase 2/phase 3
Sponsor Chisel Peak Medical Clinic
Collaborator K. Dean Reeves, M.D.
Start date January 2013
End date March 2016
Trial size 40 participants
Trial identifier NCT01706172, TMJS

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint
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)
Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint
injection of 1 ml of 0.8 sterile water /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

Primary Outcomes

Measure
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain
time frame: 3 Months

Secondary Outcomes

Measure
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction.
time frame: 3 Months
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
time frame: 1 year

Eligibility Criteria

Male or female participants from 19 years up to 90 years old.

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.

Additional Information

Official title Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy
Principal investigator W. Francois Louw, Doctor
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Chisel Peak Medical Clinic.