Clinical trial NCT01617356: Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
Official title: Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: TMD
temporomandibular
dextrose
prolotherapy
Lead sponsor: Frusso, Ricardo, M.D.
Sponsor class: INDIV
Collaborators: name: Zarate, Miguel, M.D.
First posted: 2012-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for Jaw Pain
timeFrame: 3 months
measure: 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for Jaw pain from baseline to 3 months
timeFrame: 3 months
measure: Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for jaw dysfunction.
timeFrame: 3 months
measure: 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction to 3 months
timeFrame: 3 months
measure: Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for jaw pain
timeFrame: 1 year
measure: 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw pain from baseline to 1 year
timeFrame: 1 year
measure: Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for Jaw Dysfunction
timeFrame: 1 year
measure: 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction from baseline to 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Change in mouth opening in millimeters from baseline to 3 months as manually measured by a Therabite.
timeFrame: 3 months
measure: Satisfaction to 3 months as measured by a 0-10 Numerical Rating Scale (NRS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Ricardo D Frusso, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zarate MA, Frusso RD, Reeves KD, Cheng AL, Rabago D. Dextrose Prolotherapy Versus Lidocaine Injection for Temporomandibular Dysfunction: A Pragmatic Randomized Controlled Trial. J Altern Complement Med. 2020 Nov;26(11):1064-1073. doi: 10.1089/acm.2020.0207. Epub 2020 Aug 11.