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Completed

NCT Number: NCT01617356

Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

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 be notably helpful in preliminary studies in reducing pain and improving jaw function. This randomized trial will compare dextrose injection with saline injection for temporomandibular(jaw) dysfunction, also known as TMD.

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Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1181, Argentina

About this study

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 intraarticular 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Injection of 20% dextrose/ 0.2% lidocaine

Other

Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.

Injection of 1 ml of 0.8 SW/0.2% lidocaine

Other

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

  1. Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for Jaw Pain

    Time frame: 3 months

    Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.

  2. 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for Jaw pain from baseline to 3 months

    Time frame: 3 months

    Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome.

  3. Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for jaw dysfunction.

    Time frame: 3 months

    Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.

  4. 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction to 3 months

    Time frame: 3 months

    Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome.

  5. Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for jaw pain

    Time frame: 1 year

    Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.

  6. 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw pain from baseline to 1 year

    Time frame: 1 year

    Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome.

  7. Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for Jaw Dysfunction

    Time frame: 1 year

    Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.

  8. 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction from baseline to 1 year

    Time frame: 1 year

    Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome.

Secondary outcomes

  1. Change in mouth opening in millimeters from baseline to 3 months as manually measured by a Therabite.

    Time frame: 3 months

    An increase in mouth opening in millimeters is considered an improvement in this study.

  2. Satisfaction to 3 months as measured by a 0-10 Numerical Rating Scale (NRS)

    Time frame: 3 months

    Anchors include "0 = no satisfaction" and "10 = complete satisfaction"

Sponsors and collaborators

Lead sponsor

Frusso, Ricardo, M.D.

Indiv

Collaborators

  • Zarate, Miguel, M.D.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 12, 2012
Registry last updated
Dec 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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