Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

Not Applicable

Completed

• Conditions: Temporomandibular Joint Disorders

• Registration Number: NCT01617356
• Lead Sponsor: Frusso, Ricardo, M.D.

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-12
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
50% or more improvement in 0-10 Numerical Rating Scale (NRS) for Jaw pain from baseline to 3 months	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.
50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction to 3 months	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.
Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for jaw dysfunction.	3 months	Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.
Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for jaw pain	1 year	Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.
50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw pain from baseline to 1 year	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.
Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for Jaw Pain	3 months	Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.
Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for Jaw Dysfunction	1 year	Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.
50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction from baseline to 1 year	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 Outcome Measures

Name	Time	Method
Satisfaction to 3 months as measured by a 0-10 Numerical Rating Scale (NRS)	3 months	Anchors include "0 = no satisfaction" and "10 = complete satisfaction"
Change in mouth opening in millimeters from baseline to 3 months as manually measured by a Therabite.	3 months	An increase in mouth opening in millimeters is considered an improvement in this study.

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina