Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

January 31, 2017 updated by: Dr. W Francois Louw, Chisel Peak Medical Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Invermere, British Columbia, Canada, V0A 1K0
        • Chisel Peak Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dextrose 20 % Injection
Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint
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
Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
3 Months
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
Time Frame: 1 year
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chisel Peak Medical Clinic

Collaborators

K. Dean Reeves, M.D.

Investigators

  • Principal Investigator: W. Francois Louw, Doctor, University of British Columbia, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMJS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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