Temporomandibular Joint ArthralgiaMAGARTNCT07745660
Magnesium Sulfate After TMJ Arthrocentesis
A study testing Magnesium Sulfate Group → Experimental, Hyaluronic Acid (HA) and Normal Saline (0.9% Sodium Chloride) in people with Temporomandibular Joint Arthralgia and Temporomandibular Joint Disc Displacement, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Temporomandibular joint (TMJ) arthrocentesis is a well-established minimally invasive treatment for patients with TMJ arthralgia and internal derangement. Although intra-articular hyaluronic acid is frequently administered following arthrocentesis to improve pain relief and joint function, evidence regarding the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Arthralgia, Temporomandibular Joint Disc Displacement
- What is being tested?
- Magnesium Sulfate Group → Experimental, Hyaluronic Acid (HA) and Normal Saline (0.9% Sodium Chloride)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 29 Jul 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:Age between 18 and 65 years. Diagnosis of temporomandibular joint arthralgia and/or painful disc displacement with reduction or disc displacement without reduction with limited opening according to DC/TMD Axis I criteria.
Predominantly unilateral temporomandibular joint symptoms lasting for at least 6 weeks.
Resting or chewing-related pain intensity of at least 4 on a 0-10 Visual Analog Scale.
Clinical indication for temporomandibular joint arthrocentesis. Ability to understand and complete the Turkish-language questionnaires. Provision of written informed consent. -
Exclusion Criteria:Active local or systemic infection. Advanced degenerative temporomandibular joint disease, defined by clinical crepitus together with advanced imaging findings or Wilkes stage IV-V disease.
Intra-articular injection within the previous 3 months. Temporomandibular joint arthroscopy or open joint surgery within the previous 6 months.
Pregnancy or breastfeeding. Coagulopathy or use of anticoagulant medication that could not be discontinued. Known hypersensitivity to any of the study agents. Severe psychiatric disorder or any condition preventing completion of the study questionnaires.
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Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University Faculty of Dentistry
İpekyolu, Van, 65100
About this study
Official title: Efficacy of Intra-Articular Magnesium Sulfate Compared With Hyaluronic Acid and Saline Following Temporomandibular Joint Arthrocentesis: A Three-Arm Pilot Randomized Controlled Trial
Temporomandibular joint (TMJ) arthrocentesis is a well-established minimally invasive treatment for patients with TMJ arthralgia and internal derangement. Although intra-articular hyaluronic acid is frequently administered following arthrocentesis to improve pain relief and joint function, evidence regarding the efficacy of intra-articular magnesium sulfate remains limited. Magnesium sulfate has demonstrated analgesic and anti-inflammatory properties through N-methyl-D-aspartate (NMDA) receptor antagonism and modulation of calcium influx; however, its clinical use in TMJ disorders has not been adequately investigated.
This investigator-initiated, single-center, three-arm randomized controlled pilot trial was conducted to compare the clinical effectiveness and safety of intra-articular magnesium sulfate, hyaluronic acid, and normal saline administered after TMJ arthrocentesis in patients diagnosed with TMJ arthralgia according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
The primary outcome was the change in chewing pain measured using the Visual Analog Scale (VAS) at 4 weeks. Secondary outcomes included maximum mouth opening, Jaw Functional Limitation Scale-8 (JFLS-8), Oral Health Impact Profile-14 (OHIP-14), Graded Chronic Pain Scale version 2.0 (GCPS v2.0), Patient Health Questionnaire-4 (PHQ-4), analgesic consumption, and adverse events.
Read the detailed description
Temporomandibular disorders (TMDs) are among the most common causes of chronic orofacial pain and functional limitation. Arthrocentesis is considered an effective minimally invasive treatment for patients with persistent TMJ arthralgia who do not respond adequately to conservative therapy. In addition to mechanical lavage of inflammatory mediators, several intra-articular agents have been investigated to enhance postoperative recovery and improve clinical outcomes. Hyaluronic acid is widely used because of its viscoelastic, lubricating, and anti-inflammatory properties.
Magnesium sulfate has attracted increasing interest because of its analgesic effects mediated primarily through NMDA receptor antagonism, modulation of calcium influx, and reduction of peripheral sensitization. Although beneficial effects have been reported in several musculoskeletal and postoperative pain conditions, evidence regarding intra-articular magnesium sulfate administration in temporomandibular joint disorders remains scarce.
This investigator-initiated, single-center, randomized controlled pilot trial was designed to compare intra-articular magnesium sulfate with hyaluronic acid and normal saline following TMJ arthrocentesis. Adult patients diagnosed with TMJ arthralgia according to DC/TMD criteria were randomly allocated to one of three parallel treatment groups. Arthrocentesis was performed using a standardized single-needle upper joint compartment technique, followed by administration of the allocated intra-articular agent.
The primary endpoint was the change in chewing pain measured by the Visual Analog Scale (VAS) at 4 weeks. Secondary endpoints included maximum mouth opening, Jaw Functional Limitation Scale-8 (JFLS-8), Oral Health Impact Profile-14 (OHIP-14), Graded Chronic Pain Scale version 2.0 (GCPS v2.0), Patient Health Questionnaire-4 (PHQ-4), analgesic consumption, and treatment-related adverse events. The study was designed to evaluate the clinical effectiveness and safety of magnesium sulfate as a potential adjunctive intra-articular treatment following TMJ arthrocentesis.
- Being tested
- Magnesium Sulfate Group → Experimental, Hyaluronic Acid (HA), Normal Saline (0.9% Sodium Chloride)
- Keywords
- Temporomandibular joint, Arthrocentesis, Magnesium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate Group → ExperimentalDrug
After completion of standardized single-needle temporomandibular joint arthrocentesis using 100-150 mL of normal saline, a single 1 mL intra-articular injection containing 100 mg of magnesium sulfate was administered into the upper joint compartment. The solution was prepared by diluting 0.67 mL of 15% magnesium sulfate with 0.33 mL of 0.9% sodium chloride.
Hyaluronic Acid (HA)Drug
Also called Ostenil
After completion of standardized single-needle temporomandibular joint arthrocentesis using 100-150 mL of normal saline, participants received a single intra-articular injection of 20 mg hyaluronic acid in a total volume of 1 mL into the upper joint compartment.
Normal Saline (0.9% Sodium Chloride)Drug
Also called Normal Saline
After completion of standardized single-needle temporomandibular joint arthrocentesis using 100-150 mL of normal saline, participants received a single 1 mL intra-articular injection of 0.9% sodium chloride into the upper joint compartment.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate Group | Experimental | Participants underwent temporomandibular joint arthrocentesis followed by intra-articular administration of magnesium sulfate. Receives: Drug: Magnesium Sulfate Group → Experimental |
| Hyaluronic Acid Group | Active comparator | Participants underwent temporomandibular joint arthrocentesis followed by intra-articular administration of hyaluronic acid. Receives: Drug: Hyaluronic Acid (HA) |
| Normal Saline Group | Placebo comparator | Participants underwent temporomandibular joint arthrocentesis followed by intra-articular administration of normal saline. Receives: Drug: Normal Saline (0.9% Sodium Chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Temporomandibular Joint Pain During Chewing at Week 4
Temporomandibular joint pain during chewing was assessed using an 11-point Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Change was calculated by comparing the Week 4 score with the baseline score. A greater reduction indicates greater improvement.
Measured: Baseline and Week 4 (±5 days)
Secondary outcomes (7)
Change From Baseline in Resting Temporomandibular Joint Pain Intensity
Resting temporomandibular joint pain was assessed using an 11-point Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain.
Measured: Baseline, Week 1 (Day 7 ±2 days), Week 4 (±5 days), and Week 12 (±10 days)
Change From Baseline in Temporomandibular Joint Pain During Chewing at Week 1 and Week 12
Temporomandibular joint pain during chewing was assessed using an 11-point Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain.
Measured: Baseline, Week 1 (Day 7 ±2 days), and Week 12 (±10 days)
Change From Baseline in Jaw Functional Limitation Scale-8 Score
Jaw-related functional limitation was assessed using the Jaw Functional Limitation Scale-8. The summary score was calculated according to the validated scoring instructions. Higher scores indicate greater functional limitation.
Measured: Baseline, Week 1, Week 4, and Week 12
Change From Baseline in Oral Health Impact Profile-14 Score
Oral health-related quality of life was assessed using the Oral Health Impact Profile-14. Higher scores indicate poorer oral health-related quality of life.
Measured: Baseline, Week 4, and Week 12
Change From Baseline in Maximum Mouth Opening
Maximum mouth opening was measured in millimeters between the incisal edges of the maxillary and mandibular central incisors. Higher values indicate greater mouth opening.
Measured: Baseline, Week 1, Week 4, and Week 12
Change in Graded Chronic Pain Scale Version 2.0 Classification
Chronic pain severity and pain-related disability were evaluated using the Graded Chronic Pain Scale version 2.0. Changes in chronic pain classification between baseline and Week 12 were assessed.
Measured: Baseline and Week 12
Change From Baseline in Patient Health Questionnaire-4 Score
ymptoms of anxiety and depression were assessed using the Patient Health Questionnaire-4. Higher scores indicate greater psychological distress.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Feb 2026
- Primary completion28 May 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint ArthralgiaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ceren dayanan, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745660
- Sponsor's protocol ID
- YYU-TMJ-2026-001
- Acronym
- MAGART
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intra-Articular Magnesium Sulfate Compared With Hyaluronic Acid and Saline Following Temporomandibular Joint Arthrocentesis: A Three-Arm Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07745660
- Acronym / sponsor ID
- MAGART / YYU-TMJ-2026-001
- Keywords
- Temporomandibular joint, Arthrocentesis, Magnesium sulfate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 4 Aug 2026 (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.
Temporomandibular joint (TMJ) arthrocentesis is a well-established minimally invasive treatment for patients with TMJ arthralgia and internal derangement. Although intra-articular hyaluronic acid is frequently administered following arthrocentesis to improve pain relief and joint function, evidence regarding the efficacy of intra-articular magnesium sulfate remains limited. Magnesium sulfate has demonstrated analgesic and anti-inflammatory properties through N-methyl-D-aspartate (NMDA) receptor antagonism and modulation of calcium influx; however, its clinical use in TMJ disorders has not been adequately investigated.
This investigator-initiated, single-center, three-arm randomized controlled pilot trial was conducted to compare the clinical effectiveness and safety of intra-articular magnesium sulfate, hyaluronic acid, and normal saline administered after TMJ arthrocentesis in patients diagnosed with TMJ arthralgia according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
The primary outcome was the change in chewing pain measured using the Visual Analog Scale (VAS) at 4 weeks. Secondary outcomes included maximum mouth opening, Jaw Functional Limitation Scale-8 (JFLS-8), Oral Health Impact Profile-14 (OHIP-14), Graded Chronic Pain Scale version 2.0 (GCPS v2.0), Patient Health Questionnaire-4 (PHQ-4), analgesic consumption, and adverse events.
Detailed description
Temporomandibular disorders (TMDs) are among the most common causes of chronic orofacial pain and functional limitation. Arthrocentesis is considered an effective minimally invasive treatment for patients with persistent TMJ arthralgia who do not respond adequately to conservative therapy. In addition to mechanical lavage of inflammatory mediators, several intra-articular agents have been investigated to enhance postoperative recovery and improve clinical outcomes. Hyaluronic acid is widely used because of its viscoelastic, lubricating, and anti-inflammatory properties.
Magnesium sulfate has attracted increasing interest because of its analgesic effects mediated primarily through NMDA receptor antagonism, modulation of calcium influx, and reduction of peripheral sensitization. Although beneficial effects have been reported in several musculoskeletal and postoperative pain conditions, evidence regarding intra-articular magnesium sulfate administration in temporomandibular joint disorders remains scarce.
This investigator-initiated, single-center, randomized controlled pilot trial was designed to compare intra-articular magnesium sulfate with hyaluronic acid and normal saline following TMJ arthrocentesis. Adult patients diagnosed with TMJ arthralgia according to DC/TMD criteria were randomly allocated to one of three parallel treatment groups. Arthrocentesis was performed using a standardized single-needle upper joint compartment technique, followed by administration of the allocated intra-articular agent.
The primary endpoint was the change in chewing pain measured by the Visual Analog Scale (VAS) at 4 weeks. Secondary endpoints included maximum mouth opening, Jaw Functional Limitation Scale-8 (JFLS-8), Oral Health Impact Profile-14 (OHIP-14), Graded Chronic Pain Scale version 2.0 (GCPS v2.0), Patient Health Questionnaire-4 (PHQ-4), analgesic consumption, and treatment-related adverse events. The study was designed to evaluate the clinical effectiveness and safety of magnesium sulfate as a potential adjunctive intra-articular treatment following TMJ arthrocentesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate Group | Experimental | Drug: Magnesium Sulfate Group → ExperimentalParticipants underwent temporomandibular joint arthrocentesis followed by intra-articular administration of magnesium sulfate. |
| Hyaluronic Acid Group | Active comparator | Drug: Hyaluronic Acid (HA)Participants underwent temporomandibular joint arthrocentesis followed by intra-articular administration of hyaluronic acid. |
| Normal Saline Group | Placebo comparator | Drug: Normal Saline (0.9% Sodium Chloride)Participants underwent temporomandibular joint arthrocentesis followed by intra-articular administration of normal saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Magnesium Sulfate Group → ExperimentalAfter completion of standardized single-needle temporomandibular joint arthrocentesis using 100-150 mL of normal saline, a single 1 mL intra-articular injection containing 100 mg of magnesium sulfate was administered into the upper joint compartment. The solution was prepared by diluting 0.67 mL of 15% magnesium sulfate with 0.33 mL of 0.9% sodium chloride. | Drug | Magnesium Sulfate Group |
| Hyaluronic Acid (HA)Also: OstenilAfter completion of standardized single-needle temporomandibular joint arthrocentesis using 100-150 mL of normal saline, participants received a single intra-articular injection of 20 mg hyaluronic acid in a total volume of 1 mL into the upper joint compartment. | Drug | Hyaluronic Acid Group |
| Normal Saline (0.9% Sodium Chloride)Also: Normal SalineAfter completion of standardized single-needle temporomandibular joint arthrocentesis using 100-150 mL of normal saline, participants received a single 1 mL intra-articular injection of 0.9% sodium chloride into the upper joint compartment. | Drug | Normal Saline Group |
Primary outcome
Change From Baseline in Temporomandibular Joint Pain During Chewing at Week 4
Time frame: Baseline and Week 4 (±5 days)
Temporomandibular joint pain during chewing was assessed using an 11-point Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Change was calculated by comparing the Week 4 score with the baseline score. A greater reduction indicates greater improvement.
7 secondary outcomes
Change From Baseline in Resting Temporomandibular Joint Pain Intensity
Time frame: Baseline, Week 1 (Day 7 ±2 days), Week 4 (±5 days), and Week 12 (±10 days)
Change From Baseline in Temporomandibular Joint Pain During Chewing at Week 1 and Week 12
Time frame: Baseline, Week 1 (Day 7 ±2 days), and Week 12 (±10 days)
Change From Baseline in Jaw Functional Limitation Scale-8 Score
Time frame: Baseline, Week 1, Week 4, and Week 12
Change From Baseline in Oral Health Impact Profile-14 Score
Time frame: Baseline, Week 4, and Week 12
Change From Baseline in Maximum Mouth Opening
Time frame: Baseline, Week 1, Week 4, and Week 12
Change in Graded Chronic Pain Scale Version 2.0 Classification
Time frame: Baseline and Week 12
Change From Baseline in Patient Health Questionnaire-4 Score
Time frame: Baseline and Week 12
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 4 Aug 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate Group → Experimental, Hyaluronic Acid (HA) and Normal Saline (0.9% Sodium Chloride) in people with Temporomandibular Joint Arthralgia and Temporomandibular Joint Disc Displacement, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Aug 2026. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 in Temporomandibular Joint Pain During Chewing at Week 4 (time frame: Baseline and Week 4 (±5 days)). 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 4 Aug 2026.