How dextrose prolotherapy can help relieve persistent temporomandibular joint pain and improve jaw function
| ISRCTN | ISRCTN63941479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63941479 |
| Secondary identifying numbers | DN-02092024-306 |
- Submission date
- 20/01/2025
- Registration date
- 21/01/2025
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
This study aims to see how effective injecting 5% dextrose directly into the joint is for treating symptoms of temporomandibular joint (TMJ) disc displacement without reduction, which causes limited mouth opening, in patients who haven't responded to medication and physical therapy.
Who can participate?
Females aged 18 - 35 years old with temporomandibular joint disc displacement without reduction with limited mouth opening
What does the study involve?
Participants will be randomly divided into two groups to be treated either with a 5% dextrose or saline. Pain intensity on opening and closing is measured before the injection and 2 weeks, 2 months, and 6 months after the treatment.
What are the possible benefits and risks of participating?
The anticipated benefits of this study include improving the TMJ function and enhancing the limited mouth opening. The potential risks include flare-ups.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
June 2023 to April 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
1. Yazan Sayed Taleb, yazan44.sayed@damascusuniversity.edu.sy
2. Dr Yasser Alsayed Tolibah, yasser94.tolibah@damascusuniversity.edu.sy or Yasseralsayedtolibah@gmail.com
Contact information
Public, Scientific, Principal Investigator
Almazzeh St
Damascus
20872
Syria
| Phone | +963 (0)991195863 |
|---|---|
| yazan44.sayed@damascusuniversity.edu.sy |
Study information
| Study design | Randomized triple-blinded controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | 46710_PIS.pdf |
| Scientific title | Dextrose prolotherapy effect in improving the temporomandibular joint disc displacement symptoms without reduction refractory to conservative treatment |
| Study hypothesis | The researchers evaluated the effectiveness of the 5% dextrose injection compared with placebo to test the hypothesis that it is more effective in relieving symptoms of a closed lock jaw. |
| Ethics approval(s) |
Approved 02/08/2021, Damascus University (Almazzeh St, Damascus, 20872, Syria; +963 (0)90404840; dl.srd@damascusuniversity.edu.sy), ref: 561 |
| Condition | Temporomandibular joint disc displacement without reduction |
| Intervention | Patients with symptoms of unilateral DDwoR with limited mouth opening were randomly assigned into two equal groups using the randomization tool from https://www.randomizer.org/. The study group received injections of 5% dextrose (D5W), while the control group received injections of 0.9% normal saline (NS). The patient was placed in a semisupine position, the preauricular area was disinfected with povidone 4%, and a line was drawn from the lateral canthus to the most posterior and central point on the tragus (the Holmlund–Hellsing line), on this line 10 mm anterior to tragus, point A was marked and 10 mm below this point was marked other B (Figure 1). The solution to be injected was prepared away from the patients' eyes according to the randomization process, and we asked the patient to open his mouth as wide as possible, the tip of a 27-gauge needle with 35 mm length was inserted starting at point B to a depth of approximately 25 mm in an anteromedial direction along the posterior portion of the condylar neck to reach the retrodiscal area and then was injected 1ml of solution (5% dextrose or saline) slowly after aspiration. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain assessed using the Visual Analogue Scale (VAS) at four timepoints: before injection (T0), 2 weeks after treatment (T1), 2 months after treatment (T2), and 6 months after treatment (T3) |
| Secondary outcome measures | Unassisted maximum interincisal opening (MIO), including overlap, was measured using a millimeter-scaled ruler at the same time points: before injection (T0), 2 weeks after treatment (T1), 2 months after treatment (T2), and 6 months after treatment (T3) |
| Overall study start date | 01/06/2021 |
| Overall study end date | 01/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Female |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Participant inclusion criteria | 1. Patients aged between 18 and 35 years old with symptoms of unilateral DDwoR with limited mouth opening (≥1 month) mentioned in the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), maximum assisted opening <40 mm, and restricted mouth opening that interferes with the ability to eat 2. Conservative treatments (pharmacological-physical) failed to improve their symptoms 3. Level pain≥5 on the Numeric Rating Scale (NRS). |
| Participant exclusion criteria | 1. Allergy to dextrose 2. Having parafunctional habits 3. Restriction of mouth opening by spasm muscles or joint adherence 4. Previous exposure to IAI 5. Unwillingness to continue |
| Recruitment start date | 01/08/2023 |
| Recruitment end date | 01/01/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Almazzeh St
Damascus
20872
Syria
Sponsor information
University/education
Almazzeh St
Damascus
20872
Syria
| Phone | +963 (0)90404840 |
|---|---|
| dl.srd@damascusuniversity.edu.sy | |
| Website | https://www.damascusuniversity.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Research organisation
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 01/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-review journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be available on request from Yasser Alsayed Tolibah (yasseralsayedtolibah@gmail.com). The type of data that will be shared: All data can be shared, including age and outcome measurements. Dates of availability: by 01/06/2025. Whether consent from participants was required and obtained: All patients signed an informed consent form that their data would be a part of a scientific study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 21/01/2025 | No | Yes |
Additional files
Editorial Notes
20/01/2025: Study's existence confirmed by Damascus University.
