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Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

NCT ID: NCT01617356

Last Updated: 2018-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Temporomandibular Joint Disorders

Keywords

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TMD temporomandibular dextrose prolotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dextrose Injection

Group Type ACTIVE_COMPARATOR

Injection of 20% dextrose/ 0.2% lidocaine

Intervention Type OTHER

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

Sterile Water Injection

Group Type ACTIVE_COMPARATOR

Injection of 1 ml of 0.8 SW/0.2% lidocaine

Intervention Type OTHER

Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zarate, Miguel, M.D.

INDIV

Sponsor Role collaborator

Frusso, Ricardo, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Ricardo D Frusso, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricardo D Frusso, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Locations

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Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type DERIVED
PMID: 32780636 (View on PubMed)

Other Identifiers

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Buenos Aires 1969

Identifier Type: -

Identifier Source: org_study_id