Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617356
• Other study ID #: Buenos Aires 1969
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: May 2017

Study information

• Verified date: December 2018
• Source: Frusso, Ricardo, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.
• Injection of 1 ml of 0.8 SW/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.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Ciudad Autónoma de Buenos Aires	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Frusso, Ricardo, M.D.	Zarate, Miguel, M.D.

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for Jaw Pain	Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.	3 months
Primary	50% or more improvement in 0-10 Numerical Rating Scale (NRS) for Jaw pain from baseline to 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 months
Primary	Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for jaw dysfunction.	Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.	3 months
Primary	50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction to 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 months
Primary	Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for jaw pain	Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.	1 year
Primary	50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw pain from baseline to 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.	1 year
Primary	Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for Jaw Dysfunction	Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.	1 year
Primary	50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction from baseline to 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.	1 year
Secondary	Change in mouth opening in millimeters from baseline to 3 months as manually measured by a Therabite.	An increase in mouth opening in millimeters is considered an improvement in this study.	3 months
Secondary	Satisfaction to 3 months as measured by a 0-10 Numerical Rating Scale (NRS)	Anchors include "0 = no satisfaction" and "10 = complete satisfaction"	3 months