Skip to main content
Clinical Trials/NCT01706172
NCT01706172CompletedPhase 2

Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy

Chisel Peak Medical Clinic2 sites in 1 country42 target enrollmentStarted: January 2013Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
42
Locations
2
Primary Endpoint
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain

Study Overview

Brief 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.

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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Investigators

Sponsor
Chisel Peak Medical Clinic
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. W Francois Louw

Clinical Instructor and Physician

University of British Columbia

Study Sites (2)

Loading locations...

Similar Trials