Temporomandibular Joint DisordersPhase 1/2NCT06694532
EffIcacy Between Arthrocentesis With High Versus Low Molecular Weight Hyaluronic Acid in Treatment of TMJ Disorders
A Phase 1/2 study testing Hyaluronic acid and Syringes in people with Temporomandibular Joint Disorders and Arthrocentesis, run by Basel khaled mohamed at 1 site in Egypt.
Trial summary
The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Arthrocentesis
- What is being tested?
- Hyaluronic acid and Syringes
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Oct 2023to 28 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain or tenderness of the jaw
- Pain in one or both of the temporomandibular joints
- Aching pain in and around your ear
- Difficulty chewing or pain while chewing
- Aching facial pain
- Locking of the joint,
Who cannot join
- Muscular TMJ disorders
- Bleeding tendency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Basel K Mohamed contact
Egypt1 site, 1 recruiting
- Recruiting
Assiut Univeristy
Asyut, 12346
Basel K Mohamed
About this study
Official title: Comparative Study Between the Effectiveness of High Versus Low Molecular Weight Hyaluronic Acid in TMJ Arthrocentesis
The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment.
Read the detailed description
The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.
, 1- significantly improving the pain on scale 1-10 , and 2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.
3-The presence of absence of clicking and cracking in jaw .
- Conditions
- Temporomandibular Joint Disorders, Arthrocentesis
- Being tested
- Hyaluronic acid, Syringes
- 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.
Hyaluronic acidDrug
Also called Arthrocentesis
Comparative study between Hyalgan and Hyorth injectable products in TMJ Disorders by arthrocentesis of 2 syringes device
SyringesDevice
Also called Arthrocentesis
Whilst you are asleep, two small needles will be inserted into the TMJ / Jaw Joint. One of these needles allows sterile saline to be pumped into the joint under pressure whilst the other needle allows the saline to drain out of the joint then injection of the HA injectiable products .
| Study group | Role | What they receive |
|---|---|---|
| high molucular weight hyalurinic acid . | Experimental | patients injected e high molucular weight hyalurinic acid . Receives: Drug: Hyaluronic acid; Device: Syringes |
| low molcular weight hyaurinic acid | Experimental | patients injected with low molucular weight hyalurinic acid . Receives: Drug: Hyaluronic acid; Device: Syringes |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis
The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.
, 1- significantly improving the pain on scale 1-10 , and
Measured: 36 months
Secondary outcomes (1)
comparative between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis
The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.
2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start31 Oct 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basel khaled mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Basel khaled mohamed, Assiut University
- Investigators
- Basel K Mohamed, Principal investigator, Assiut Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694532
- Sponsor's protocol ID
- Hyaluronic and TMJ Disorders
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Effectiveness of High Versus Low Molecular Weight Hyaluronic Acid in TMJ Arthrocentesis
- ClinicalTrials.gov ID
- NCT06694532
- Acronym / sponsor ID
- Hyaluronic and TMJ Disorders
- Conditions
- Temporomandibular Joint Disorders, Arthrocentesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Basel khaled mohamedUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 19 Nov 2024 (actual)
- 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.
The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment.
Detailed description
The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.
, 1- significantly improving the pain on scale 1-10 , and 2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.
3-The presence of absence of clicking and cracking in jaw .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high molucular weight hyalurinic acid . | Experimental | Drug: Hyaluronic acid, Device: Syringespatients injected e high molucular weight hyalurinic acid . |
| low molcular weight hyaurinic acid | Experimental | Drug: Hyaluronic acid, Device: Syringespatients injected with low molucular weight hyalurinic acid . |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pain or tenderness of the jaw
- Pain in one or both of the temporomandibular joints
- Aching pain in and around your ear
- Difficulty chewing or pain while chewing
- Aching facial pain
Key exclusion criteria (2 listed)
- Muscular TMJ disorders
- Bleeding tendency
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 |
|---|---|---|
| Hyaluronic acidAlso: ArthrocentesisComparative study between Hyalgan and Hyorth injectable products in TMJ Disorders by arthrocentesis of 2 syringes device | Drug | high molucular weight hyalurinic acid ., low molcular weight hyaurinic acid |
| SyringesAlso: ArthrocentesisWhilst you are asleep, two small needles will be inserted into the TMJ / Jaw Joint. One of these needles allows sterile saline to be pumped into the joint under pressure whilst the other needle allows the saline to drain out of the joint then injection of the HA injectiable products . | Device | high molucular weight hyalurinic acid ., low molcular weight hyaurinic acid |
Primary outcome
EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis
Time frame: 36 months
The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder. , 1- significantly improving the pain on scale 1-10 , and
1 secondary outcome
comparative between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Basel K Mohamed contact
Basel K Mohamed principal investigator
Assiut Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyaluronic acid and Syringes in people with Temporomandibular Joint Disorders and Arthrocentesis, run by Basel khaled mohamed at 1 site in Egypt.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. 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 Egypt. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Basel K Mohamed (+201099848089, Basel_shrider@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2024.