Trial record 1 of 1 for:    NCT01617356
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Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Zarate, Miguel, M.D.
Information provided by (Responsible Party):
Ricardo D Frusso, M.D., Frusso, Ricardo, M.D.
ClinicalTrials.gov Identifier:
NCT01617356
First received: June 5, 2012
Last updated: August 16, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Temporomandibular Joint Disorders
Other: Injection of 20% dextrose/ 0.2% lidocaine
Other: Injection of 1 ml of 0.8 SW/0.2% lidocaine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy

Resource links provided by NLM:


Further study details as provided by Frusso, Ricardo, M.D.:

Primary Outcome Measures:
  • Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.


Secondary Outcome Measures:
  • Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Description: TMJ injection of 20% dextrose will result in significantly more improvement in Jaw Dysfunction at 3 months. Jaw dysfunction is rated based on the worst of the following: Chewing difficulty, jaw tension or stiffness, fatigue with eating, or grinding noises

  • Long term change from baseline in Numerical Rating Scale (NRS) for Jaw Pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.


Estimated Enrollment: 42
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617356

Locations
Argentina
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1181
Sponsors and Collaborators
Frusso, Ricardo, M.D.
Zarate, Miguel, M.D.
Investigators
Principal Investigator: Ricardo D Frusso, M.D. Hospital Italiano de Buenos Aires
  More Information

No publications provided

Responsible Party: Ricardo D Frusso, M.D., Principal Investigator, Frusso, Ricardo, M.D.
ClinicalTrials.gov Identifier: NCT01617356     History of Changes
Other Study ID Numbers: Buenos Aires 1969
Study First Received: June 5, 2012
Last Updated: August 16, 2012
Health Authority: Argentina: Human Research Bioethics Committee

Keywords provided by Frusso, Ricardo, M.D.:
TMD
temporomandibular
dextrose
prolotherapy

Additional relevant MeSH terms:
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Jaw Diseases
Mandibular Diseases
Muscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Stomatognathic Diseases
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 22, 2014