TMJ Disc Displacement With ReductionRCTNCT06839430
Therapeutic Effect of Using Injectable Hypertonic Saline 5% Versus Injectable Dextrose 20% on Pain in Painful Cases of Disc Displacement With Reduction
A study testing hypertonic saline 5% sodium chloride and hypertonic dextrose 20% in people with TMJ Disc Displacement With Reduction, run by Cairo University.
Trial summary
This study is aiming to assess effect of hypertonic saline 5% in comparison to dextrose 20% on pain ,inter-insical opening and movements of jaw in painful cases of disc displacement with reduction Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- TMJ Disc Displacement With Reduction
- What is being tested?
- hypertonic saline 5% sodium chloride and hypertonic dextrose 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 20 Sep 2026
- Phase
- Interventional
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- presence of one or more of the following observations in one or both temporomandibular joints:
- pain.
- audible clicking.
- mandibular deviation on opening.
- Failure of conservative treatment
Who cannot join
- The clinical or radiographic signs of disc displacement without reduction, osteoarthritis, or articular bony changes.
- Previous TMJ surgery, arthrocentesis, , or the presence of any systemic disease that would affect the TMJ anatomy or mechanical function.
- A history of allergic reactions to any components of the injectable solution.
- Infection of the affected joint and pre-auricular area.
- Previous surgery of the affected joint
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Therapeutic Effect of Using Injectable Hypertonic Saline 5% Versus Injectable Dextrose 20% on Pain in Painful Cases of Disc Displacement With Reduction ( A Randomized Clinical Trial)
This study is aiming to assess effect of hypertonic saline 5% in comparison to dextrose 20% on pain ,inter-insical opening and movements of jaw in painful cases of disc displacement with reduction
Read the detailed description
Intra-articular disorders of the TMJ have been defined as an abnormal positional relationship between the disc and the condyle, articular eminence, and/or articular fossa.
The term internal derangement of the temporomandibular joint (TMJ) indicates an abnormal relationship between the disc, the condyle, and the articular eminence that constrains proper joint function
The disc displacement could be with or without reduction. In disc displacement with reduction, the disc is displaced anterior to the condylar head and remains in this position as long as the mouth is closed. Upon mouth opening, the disc regains its position on the condylar head. The movement of the disc onto and off the condylar head may lead to a clicking sound .
The precise source of internal derangements is not clear; however, it is a complex disorder likely caused by a combination of micro- or macro-trauma, parafunctional behavior, laxity of the joint's soft tissues, and alterations in the synovial fluid's composition
The aims of the internal derangement treatment include alleviating pain, reducing or eliminating joint noises, increasing the degree of mouth opening, and consequently restoring normal TMJ function.
Soft diet, behavior adjustment, analgesics, occlusal splints, intra-articular injections, physiotherapy, arthrocentesis, arthroscopy, and open joint surgery are the most common therapeutic techniques Injecting a non pharmacological irritant solution ,such as dextrose, into the area of the tendons or ligaments is known as prolotherapy, which is also known as regenerative injection therapy. It is hypothesized that this procedure elicits a non inflammatory or inflammatory process that ultimately leads to the deposition of new collagen fibers that strengthen lax tendons or ligaments and possibly encourage the release of local growth factor Different substances have been utilized for prolotherapy, but hypertonic dextrose is the most commonly utilized solution since it is affordable, accessible, and safe to inject Dextrose solution has been used at various concentrations ranging from 10% to 50% The superior joint space and peri-capsular soft tissues are usually injected during traditional prolotherapy of the TMJ.
Injection treatment of TMJs is currently one of the recognized therapeutic techniques.
Due to its invasive nature, only patients who have exhausted the less invasive treatment options are typically eligible for injection treatment.
Depending on the injectable substance used, injection treatment provides pain relief and increases the range of mandibular mobility Hypertonic saline , administered via intra-articular injection has been widely used in many previous clinical trials ,it has been used in patients with knee osteoarthritis and show significant improvement regarding pain, stiffness and function of joint hypertonic saline has a significant pain relief effect ,it acts as an analgesic by alleviating nociceptive pain from inflamed tissues, which may include bone, connective tissue, synovium, or a combination of these
- Conditions
- TMJ Disc Displacement With Reduction
- Being tested
- hypertonic saline 5% sodium chloride, hypertonic dextrose 20%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic saline 5% sodium chlorideOther
Hypertonic saline acts as an analgesic by alleviating nociceptive pain from inflamed tissues, which may include bone, connective tissue , synovium , or a combination of these Hypertonic saline results in safe and remarkable outcomes on knee pain, stiffness and function compared with intra-articular dextrose injection
hypertonic dextrose 20%Other
A recent study showed the sensorineural analgesic effect of 5% dextrose prolotherapy in the treatment of chronic low back pain ,Therefore, the mechanism of action for dextrose prolotherapy is hypothesized to work through reducing peripheral sensitization and targeting structural dysfunction
| Study group | Role | What they receive |
|---|---|---|
| painful cases with disc displacement with reduction | Active comparator | Not described |
| painful cases of disc displacement with reduction | Experimental | Not described Receives: Other: hypertonic saline 5% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of pain
severity of pain is measured by Visual analog scale (VAS) From (0-10) Where 0: no pain 10: worst pain
Measured: baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TMJ Disc Displacement With ReductionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Allah Gamal Salah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839430
- Sponsor's protocol ID
- injection in TMJ
- Acronym
- RCT
- Status last verified
- Mar 2025
- First submitted
- 17 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibaly A, Abdelmoiz M, Alghandour AN. Evaluation of the effect of dextrose prolotherapy versus deep dry needling therapy for the treatment of temporomandibular joint anterior disc displacement with reduction: (a randomized controlled trial). Clin Oral Investig. 2024 Aug 8;28(9):475. doi: 10.1007/s00784-024-05830-z.
PubMed 39115583Mohammed MR, Hamad SA, Al-Dawoody AD, Shehab AA, Ahmed OS. Effect of dextrose prolotherapy on internal derangement of the temporomandibular joint. Eur Rev Med Pharmacol Sci. 2023 Jun;27(11):4883-4889. doi: 10.26355/eurrev_202306_32605.
PubMed 37318462Zin'kovskii VG, Golovenko NIa, Bogatskii AV. [Nature of the relation between the anticonvulsant action of phenazepam and its concentration in mouse brain]. Biull Eksp Biol Med. 1981;91(1):40-2. Russian.
PubMed 7214004
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Using Injectable Hypertonic Saline 5% Versus Injectable Dextrose 20% on Pain in Painful Cases of Disc Displacement With Reduction ( A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06839430
- Acronym / sponsor ID
- RCT / injection in TMJ
- Conditions
- TMJ Disc Displacement With Reduction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 21 Feb 2025 (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.
This study is aiming to assess effect of hypertonic saline 5% in comparison to dextrose 20% on pain ,inter-insical opening and movements of jaw in painful cases of disc displacement with reduction
Detailed description
Intra-articular disorders of the TMJ have been defined as an abnormal positional relationship between the disc and the condyle, articular eminence, and/or articular fossa.
The term internal derangement of the temporomandibular joint (TMJ) indicates an abnormal relationship between the disc, the condyle, and the articular eminence that constrains proper joint function
The disc displacement could be with or without reduction. In disc displacement with reduction, the disc is displaced anterior to the condylar head and remains in this position as long as the mouth is closed. Upon mouth opening, the disc regains its position on the condylar head. The movement of the disc onto and off the condylar head may lead to a clicking sound .
The precise source of internal derangements is not clear; however, it is a complex disorder likely caused by a combination of micro- or macro-trauma, parafunctional behavior, laxity of the joint's soft tissues, and alterations in the synovial fluid's composition
The aims of the internal derangement treatment include alleviating pain, reducing or eliminating joint noises, increasing the degree of mouth opening, and consequently restoring normal TMJ function.
Soft diet, behavior adjustment, analgesics, occlusal splints, intra-articular injections, physiotherapy, arthrocentesis, arthroscopy, and open joint surgery are the most common therapeutic techniques Injecting a non pharmacological irritant solution ,such as dextrose, into the area of the tendons or ligaments is known as prolotherapy, which is also known as regenerative injection therapy. It is hypothesized that this procedure elicits a non inflammatory or inflammatory process that ultimately leads to the deposition of new collagen fibers that strengthen lax tendons or ligaments and possibly encourage the release of local growth factor Different substances have been utilized for prolotherapy, but hypertonic dextrose is the most commonly utilized solution since it is affordable, accessible, and safe to inject Dextrose solution has been used at various concentrations ranging from 10% to 50% The superior joint space and peri-capsular soft tissues are usually injected during traditional prolotherapy of the TMJ.
Injection treatment of TMJs is currently one of the recognized therapeutic techniques.
Due to its invasive nature, only patients who have exhausted the less invasive treatment options are typically eligible for injection treatment.
Depending on the injectable substance used, injection treatment provides pain relief and increases the range of mandibular mobility Hypertonic saline , administered via intra-articular injection has been widely used in many previous clinical trials ,it has been used in patients with knee osteoarthritis and show significant improvement regarding pain, stiffness and function of joint hypertonic saline has a significant pain relief effect ,it acts as an analgesic by alleviating nociceptive pain from inflamed tissues, which may include bone, connective tissue, synovium, or a combination of these
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| painful cases with disc displacement with reduction | Active comparator | – |
| painful cases of disc displacement with reduction | Experimental | Other: hypertonic saline 5% sodium chloride |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- presence of one or more of the following observations in one or both temporomandibular joints:
Key exclusion criteria (5 listed)
- The clinical or radiographic signs of disc displacement without reduction, osteoarthritis, or articular bony changes.
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 |
|---|---|---|
| hypertonic saline 5% sodium chlorideHypertonic saline acts as an analgesic by alleviating nociceptive pain from inflamed tissues, which may include bone, connective tissue , synovium , or a combination of these Hypertonic saline results in safe and remarkable outcomes on knee pain, stiffness and function compared with intra-articular dextrose injection | Other | painful cases of disc displacement with reduction |
| hypertonic dextrose 20%A recent study showed the sensorineural analgesic effect of 5% dextrose prolotherapy in the treatment of chronic low back pain ,Therefore, the mechanism of action for dextrose prolotherapy is hypothesized to work through reducing peripheral sensitization and targeting structural dysfunction | Other | – |
Primary outcome
Severity of pain
Time frame: baseline and at 6 months
severity of pain is measured by Visual analog scale (VAS) From (0-10) Where 0: no pain 10: worst pain
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 7 Mar 2025.
- Background: PubMed 39115583Gibaly A, Abdelmoiz M, Alghandour AN. Evaluation of the effect of dextrose prolotherapy versus deep dry needling therapy for the treatment of temporomandibular joint anterior disc displacement with reduction: (a randomized controlled trial). Clin Oral Investig. 2024 Aug 8;28(9):475. doi: 10.1007/s00784-024-05830-z.
- Background: PubMed 37318462Mohammed MR, Hamad SA, Al-Dawoody AD, Shehab AA, Ahmed OS. Effect of dextrose prolotherapy on internal derangement of the temporomandibular joint. Eur Rev Med Pharmacol Sci. 2023 Jun;27(11):4883-4889. doi: 10.26355/eurrev_202306_32605.
- Results publication: PubMed 7214004Zin'kovskii VG, Golovenko NIa, Bogatskii AV. [Nature of the relation between the anticonvulsant action of phenazepam and its concentration in mouse brain]. Biull Eksp Biol Med. 1981;91(1):40-2. Russian.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing hypertonic saline 5% sodium chloride and hypertonic dextrose 20% in people with TMJ Disc Displacement With Reduction, run by Cairo University.
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 5 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: opening soon, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 aya allah gamal salah, bachelors degree (+20 1005557843, ayaallah.gamal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of pain (time frame: baseline and at 6 months). 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 NCT06839430, which also lists 3 linked publications.
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 7 Mar 2025.