Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 5, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedDecember 10, 2018
December 1, 2018
4.9 years
June 5, 2012
December 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
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
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
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
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
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
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
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 Outcomes (2)
Change in mouth opening in millimeters from baseline to 3 months as manually measured by a Therabite.
3 months
Satisfaction to 3 months as measured by a 0-10 Numerical Rating Scale (NRS)
3 months
Study Arms (2)
Dextrose Injection
ACTIVE COMPARATORSterile Water Injection
ACTIVE COMPARATORInterventions
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 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.
Eligibility Criteria
You may qualify if:
- Facial Pain NRS rating \> 5/10
- Jaw symptom rating \> 5/10
- Jaw function issues seen on examination
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Frusso, Ricardo, M.D.lead
- Zarate, Miguel, M.D.collaborator
Study Sites (1)
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1181, Argentina
Related Publications (1)
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.
PMID: 32780636DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo D Frusso, M.D.
Hospital Italiano de Buenos Aires
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 5, 2012
First Posted
June 12, 2012
Study Start
June 1, 2012
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
December 10, 2018
Record last verified: 2018-12