Temporomandibular Joint DisordersNCT01617356
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
A study testing Injection of 20% dextrose/ 0.2% lidocaine and Injection of 1 ml of 0.8 SW/0.2% lidocaine in people with Temporomandibular Joint Disorders, run by Frusso, Ricardo, M.D. at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Injection of 20% dextrose/ 0.2% lidocaine and Injection of 1 ml of 0.8 SW/0.2% lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- Jun 2012to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Facial Pain NRS rating > 5/10
- Jaw symptom rating > 5/10
- Jaw function issues seen on examination
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1181
About this study
Official title: Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy
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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Injection of 20% dextrose/ 0.2% lidocaine, Injection of 1 ml of 0.8 SW/0.2% lidocaine
- Keywords
- TMD, temporomandibular, dextrose, prolotherapy
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of 20% dextrose/ 0.2% lidocaineOther
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.
Injection of 1 ml of 0.8 SW/0.2% lidocaineOther
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Dextrose Injection | Active comparator | Not described Receives: Other: Injection of 20% dextrose/ 0.2% lidocaine |
| Sterile Water Injection | Active comparator | Not described Receives: Other: Injection of 1 ml of 0.8 SW/0.2% lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 3 months
Satisfaction to 3 months as measured by a 0-10 Numerical Rating Scale (NRS)
Anchors include "0 = no satisfaction" and "10 = complete satisfaction"
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frusso, Ricardo, M.D.
- Collaborators
- Zarate, Miguel, M.D.
- Responsible party
- Principal investigator, Ricardo D Frusso, M.D., Frusso, Ricardo, M.D.
- Investigators
- Ricardo D Frusso, M.D., Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617356
- Sponsor's protocol ID
- Buenos Aires 1969
- Status last verified
- Dec 2018
- First submitted
- 5 Jun 2012
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32780636
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy
- ClinicalTrials.gov ID
- NCT01617356
- Acronym / sponsor ID
- Buenos Aires 1969
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- TMD, temporomandibular, dextrose, prolotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Frusso, Ricardo, M.D.
- Collaborators
- Zarate, Miguel, M.D.
- Study start
- Jun 2012
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextrose Injection | Active comparator | Other: Injection of 20% dextrose/ 0.2% lidocaine |
| Sterile Water Injection | Active comparator | Other: Injection of 1 ml of 0.8 SW/0.2% lidocaine |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Facial Pain NRS rating > 5/10
- Jaw symptom rating > 5/10
- Jaw function issues seen on examination
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of 20% dextrose/ 0.2% lidocaineInjection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine. | Other | Dextrose Injection |
| Injection of 1 ml of 0.8 SW/0.2% lidocaineInjection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine. | Other | Sterile Water Injection |
Primary outcome
Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for Jaw Pain
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Change in mouth opening in millimeters from baseline to 3 months as manually measured by a Therabite.
Time frame: 3 months
Satisfaction to 3 months as measured by a 0-10 Numerical Rating Scale (NRS)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Derived from this study: PubMed 32780636Zarate 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo D Frusso, M.D. principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of 20% dextrose/ 0.2% lidocaine and Injection of 1 ml of 0.8 SW/0.2% lidocaine in people with Temporomandibular Joint Disorders, run by Frusso, Ricardo, M.D. at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for Jaw Pain (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01617356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.