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Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

Primary Purpose

Temporomandibular Joint Disorders

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Injection of 20% dextrose/ 0.2% lidocaine
Injection of 1 ml of 0.8 SW/0.2% lidocaine
Sponsored by
Frusso, Ricardo, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring TMD, temporomandibular, dextrose, prolotherapy

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Italiano de Buenos Aires

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dextrose Injection

Sterile Water Injection

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
Satisfaction to 3 months as measured by a 0-10 Numerical Rating Scale (NRS)
Anchors include "0 = no satisfaction" and "10 = complete satisfaction"

Full Information

First Posted
June 5, 2012
Last Updated
December 7, 2018
Sponsor
Frusso, Ricardo, M.D.
Collaborators
Zarate, Miguel, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01617356
Brief Title
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
Official Title
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Frusso, Ricardo, M.D.
Collaborators
Zarate, Miguel, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
TMD, temporomandibular, dextrose, prolotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dextrose Injection
Arm Type
Active Comparator
Arm Title
Sterile Water Injection
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Injection of 20% dextrose/ 0.2% lidocaine
Intervention Description
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.
Intervention Type
Other
Intervention Name(s)
Injection of 1 ml of 0.8 SW/0.2% lidocaine
Intervention Description
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine.
Primary Outcome Measure Information:
Title
Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for Jaw Pain
Description
Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.
Time Frame
3 months
Title
50% or more improvement in 0-10 Numerical Rating Scale (NRS) for Jaw pain from baseline to 3 months
Description
Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome.
Time Frame
3 months
Title
Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for jaw dysfunction.
Description
Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.
Time Frame
3 months
Title
50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction to 3 months
Description
Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome.
Time Frame
3 months
Title
Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for jaw pain
Description
Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.
Time Frame
1 year
Title
50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw pain from baseline to 1 year
Description
Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome.
Time Frame
1 year
Title
Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for Jaw Dysfunction
Description
Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale.
Time Frame
1 year
Title
50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction from baseline to 1 year
Description
Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in mouth opening in millimeters from baseline to 3 months as manually measured by a Therabite.
Description
An increase in mouth opening in millimeters is considered an improvement in this study.
Time Frame
3 months
Title
Satisfaction to 3 months as measured by a 0-10 Numerical Rating Scale (NRS)
Description
Anchors include "0 = no satisfaction" and "10 = complete satisfaction"
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo D Frusso, M.D.
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
32780636
Citation
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.
Results Reference
derived

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Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

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