Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

Sponsor

Frusso, Ricardo, M.D. (Other)

Overall Status

Completed

CT.gov ID

NCT01617356

Collaborator

Zarate, Miguel, M.D. (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Joint Disorders	Other: Injection of 20% dextrose/ 0.2% lidocaine Other: Injection of 1 ml of 0.8 SW/0.2% lidocaine	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dextrose Injection	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	Other: 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.

Arm

Intervention/Treatment

Active Comparator: Dextrose Injection

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

Other: 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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.
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 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 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

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.
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"