Chronic Masticatory Myofascial PainNCT07860658
Magnesium Citrate in Chronic Masticatory Myofascial Pain
A study testing Magnesium citrate and Behavioral counseling in people with Chronic Masticatory Myofascial Pain, run by Muhammet Yasin Pektaş at 1 site in Turkey (Türkiye).
Trial summary
This study examined whether adding an oral magnesium supplement to behavioral counseling reduced pain in adults with chronic jaw muscle pain. Fifty adults were randomly assigned to two groups. One group received magnesium citrate providing 200 mg of elemental magnesium daily for 30 days and behavioral counseling. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Masticatory Myofascial Pain
- What is being tested?
- Magnesium citrate and Behavioral counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 Jul 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years.
- DC/TMD Axis I diagnosis of myalgia/myofascial pain.
- Pain persisting or recurring for at least 3 months.
- Palpable trigger points in the masseter or temporalis muscles.
Who cannot join
- Other TMD subtypes.
- Systemic inflammatory or neurological disorders.
- Current magnesium supplementation.
- Contraindications to magnesium.
- Renal impairment.
- Pregnancy.
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- Severe psychiatric disorders.
- Ongoing TMD-related litigation.
- Inability to complete Turkish questionnaires.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Afyonkarahisar Health Sciences University
Afyonkarahisar
About this study
Official title: Oral Magnesium Citrate as an Adjunct to Behavioral Counseling for Chronic Masticatory Myofascial Pain: An Assessor-Blinded Randomized Controlled Trial
This study examined whether adding an oral magnesium supplement to behavioral counseling reduced pain in adults with chronic jaw muscle pain. Fifty adults were randomly assigned to two groups. One group received magnesium citrate providing 200 mg of elemental magnesium daily for 30 days and behavioral counseling. The other group received behavioral counseling alone. Pain, jaw movement, jaw function, pain-related disability, and anxiety were assessed before treatment and at 1 and 3 months. The main outcome was jaw muscle pain intensity at 3 months. Adverse events were also recorded. The study was completed before registration.
Read the detailed description
This single-center, parallel-group randomized trial evaluated oral magnesium citrate as an adjunct to behavioral counseling in adults with chronic masticatory myofascial pain diagnosed using the DC/TMD Axis I examination. Fifty participants were assigned in a 1:1 ratio to magnesium citrate plus behavioral counseling or behavioral counseling alone. An independent statistician generated the allocation sequence using simple randomization and prepared sequentially numbered, sealed, opaque envelopes. Participants and the treating clinician knew the assigned treatment. Clinical outcome assessments were performed by a trained examiner who was not involved in treatment delivery and was blinded to group allocation. Assessments were performed at baseline and 1 and 3 months after randomization.
The study protocol was approved by the Afyonkarahisar Health Sciences University Clinical Research Ethics Committee on 13 May 2022 (approval number 2022/245; meeting number 2022/6; decision number 245). Regulatory authorization was obtained from the Turkish Medicines and Medical Devices Agency on 29 March 2023 (Clinical Trial Reference 22-AKD-151). All participants provided written informed consent before enrollment.
- Conditions
- Chronic Masticatory Myofascial Pain
- Being tested
- Magnesium citrate, Behavioral counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium citrateDietary supplement
A commercially available magnesium citrate preparation (VeNatura, Türkiye) providing 200 mg of elemental magnesium, taken orally as one tablet daily with food for 30 days. Participants purchased the product themselves.
Behavioral counselingBehavioural
A single standardized 30-minute session covering education about temporomandibular disorders, self-management, avoidance of parafunctional habits, self-massage, thermal therapy, and dietary recommendations to reduce jaw strain. The same orofacial pain specialist delivered counseling in both groups using a written protocol and checklist. Participants received written instructions for home practice.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Citrate Plus Behavioral Counseling | Experimental | Twenty-five participants received oral magnesium citrate providing 200 mg of elemental magnesium once daily with food for 30 days, together with a single standardized 30-minute behavioral counseling session. Receives: Dietary Supplement: Magnesium citrate; Behavioral: Behavioral counseling |
| Behavioral Counseling Alone | Active comparator | Twenty-five participants received a single standardized 30-minute behavioral counseling session. They received no magnesium supplement or placebo. Receives: Behavioral: Behavioral counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory Muscle Pain Intensity
Masticatory muscle pain intensity measured on a 10-cm visual analogue scale (VAS), reflecting average pain over the preceding 7 days. VAS was assessed at baseline and 1 and 3 months after randomization; the 3-month assessment was the primary outcome.
Measured: 3 months after randomization
Secondary outcomes (10)
Maximum Unassisted Mouth Opening
Maximum unassisted mouth opening measured in millimeters with a digital caliper. Measurements were obtained in triplicate and averaged for analysis.
Measured: Baseline, 1 month, and 3 months after randomization
Contralateral Mandibular Excursion
Contralateral mandibular excursion measured in millimeters with a digital caliper. Measurements were obtained in triplicate and averaged for analysis.
Measured: Baseline, 1 month, and 3 months after randomization
Ipsilateral Mandibular Excursion
Ipsilateral mandibular excursion measured in millimeters with a digital caliper. Measurements were obtained in triplicate and averaged for analysis.
Measured: Baseline, 1 month, and 3 months after randomization
Mandibular Protrusion
Protrusive mandibular excursion measured in millimeters with a digital caliper. Measurements were obtained in triplicate and averaged for analysis.
Measured: Baseline, 1 month, and 3 months after randomization
Jaw Functional Limitation Scale-20 Global Score
The JFLS-20 global score was calculated as the mean of all 20 items, with scores ranging from 0 to 10.
Measured: Baseline, 1 month, and 3 months after randomization
Jaw Functional Limitation Scale-20 Subscale Scores
JFLS-20 mastication (items 1-6), mobility (items 7-10), and verbal and emotional expression (items 13-20) subscale scores were calculated as the means of their items, with scores ranging from 0 to 10.
Measured: Baseline, 1 month, and 3 months after randomization
TMD Pain Screener Positive Status
TMD Pain Screener scores range from 0 to 7. A score of 3 or higher was considered positive. The proportion of participants with a positive result was assessed.
Measured: Baseline, 1 month, and 3 months after randomization
Graded Chronic Pain Scale Version 2 Grade
The GCPS-2, with a 30-day recall, was used to characterize pain intensity and pain-related disability. Participants were classified into grades 0-IV. Grade II indicates high-intensity pain with low disability; grades III-IV indicate high pain-related disability.
Measured: Baseline, 1 month, and 3 months after randomization
Generalized Anxiety Disorder-7 Category
GAD-7 total scores were categorized as minimal (0-4), mild (5-9), moderate (10-14), or severe (15-21) anxiety.
Measured: Baseline, 1 month, and 3 months after randomization
Adverse Events
Adverse events were recorded through open-ended questioning by the blinded assessor at each follow-up visit. Reported events were documented and categorized according to severity and relationship to the intervention. No structured symptom checklist was used.
Measured: At the 1-month and 3-month follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Jul 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Masticatory Myofascial PainStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammet Yasin Pektaş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammet Yasin Pektaş, Kutahya Health Sciences University
- Investigators
- Olgun Topal, DDS, PhD, Principal investigator, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860658
- Sponsor's protocol ID
- 2022/245
- Other IDs
- 22-AKD-151
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the article, together with the data dictionary, study protocol, and statistical analysis code, will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Magnesium Citrate as an Adjunct to Behavioral Counseling for Chronic Masticatory Myofascial Pain: An Assessor-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07860658
- Acronym / sponsor ID
- 2022/245
- Conditions
- Chronic Masticatory Myofascial Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Muhammet Yasin PektaşUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 6 Oct 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.
This study examined whether adding an oral magnesium supplement to behavioral counseling reduced pain in adults with chronic jaw muscle pain. Fifty adults were randomly assigned to two groups. One group received magnesium citrate providing 200 mg of elemental magnesium daily for 30 days and behavioral counseling. The other group received behavioral counseling alone. Pain, jaw movement, jaw function, pain-related disability, and anxiety were assessed before treatment and at 1 and 3 months. The main outcome was jaw muscle pain intensity at 3 months. Adverse events were also recorded. The study was completed before registration.
Detailed description
This single-center, parallel-group randomized trial evaluated oral magnesium citrate as an adjunct to behavioral counseling in adults with chronic masticatory myofascial pain diagnosed using the DC/TMD Axis I examination. Fifty participants were assigned in a 1:1 ratio to magnesium citrate plus behavioral counseling or behavioral counseling alone. An independent statistician generated the allocation sequence using simple randomization and prepared sequentially numbered, sealed, opaque envelopes. Participants and the treating clinician knew the assigned treatment. Clinical outcome assessments were performed by a trained examiner who was not involved in treatment delivery and was blinded to group allocation. Assessments were performed at baseline and 1 and 3 months after randomization.
The study protocol was approved by the Afyonkarahisar Health Sciences University Clinical Research Ethics Committee on 13 May 2022 (approval number 2022/245; meeting number 2022/6; decision number 245). Regulatory authorization was obtained from the Turkish Medicines and Medical Devices Agency on 29 March 2023 (Clinical Trial Reference 22-AKD-151). All participants provided written informed consent before enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Citrate Plus Behavioral Counseling | Experimental | Dietary Supplement: Magnesium citrate, Behavioral: Behavioral counselingTwenty-five participants received oral magnesium citrate providing 200 mg of elemental magnesium once daily with food for 30 days, together with a single standardized 30-minute behavioral counseling session. |
| Behavioral Counseling Alone | Active comparator | Behavioral: Behavioral counselingTwenty-five participants received a single standardized 30-minute behavioral counseling session. They received no magnesium supplement or placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 years.
- DC/TMD Axis I diagnosis of myalgia/myofascial pain.
- Pain persisting or recurring for at least 3 months.
- Palpable trigger points in the masseter or temporalis muscles.
Key exclusion criteria (9 listed)
- Other TMD subtypes.
- Systemic inflammatory or neurological disorders.
- Current magnesium supplementation.
- Contraindications to magnesium.
- Renal impairment.
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 citrateA commercially available magnesium citrate preparation (VeNatura, Türkiye) providing 200 mg of elemental magnesium, taken orally as one tablet daily with food for 30 days. Participants purchased the product themselves. | Dietary supplement | Magnesium Citrate Plus Behavioral Counseling |
| Behavioral counselingA single standardized 30-minute session covering education about temporomandibular disorders, self-management, avoidance of parafunctional habits, self-massage, thermal therapy, and dietary recommendations to reduce jaw strain. The same orofacial pain specialist delivered counseling in both groups using a written protocol and checklist. Participants received written instructions for home practice. | Behavioural | Behavioral Counseling Alone, Magnesium Citrate Plus Behavioral Counseling |
Primary outcome
Masticatory Muscle Pain Intensity
Time frame: 3 months after randomization
Masticatory muscle pain intensity measured on a 10-cm visual analogue scale (VAS), reflecting average pain over the preceding 7 days. VAS was assessed at baseline and 1 and 3 months after randomization; the 3-month assessment was the primary outcome.
10 secondary outcomes
Maximum Unassisted Mouth Opening
Time frame: Baseline, 1 month, and 3 months after randomization
Contralateral Mandibular Excursion
Time frame: Baseline, 1 month, and 3 months after randomization
Ipsilateral Mandibular Excursion
Time frame: Baseline, 1 month, and 3 months after randomization
Mandibular Protrusion
Time frame: Baseline, 1 month, and 3 months after randomization
Jaw Functional Limitation Scale-20 Global Score
Time frame: Baseline, 1 month, and 3 months after randomization
Jaw Functional Limitation Scale-20 Subscale Scores
Time frame: Baseline, 1 month, and 3 months after randomization
TMD Pain Screener Positive Status
Time frame: Baseline, 1 month, and 3 months after randomization
Graded Chronic Pain Scale Version 2 Grade
Time frame: Baseline, 1 month, and 3 months after randomization
Generalized Anxiety Disorder-7 Category
Time frame: Baseline, 1 month, and 3 months after randomization
Adverse Events
Time frame: At the 1-month and 3-month follow-up visits
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 6 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the article, together with the data dictionary, study protocol, and statistical analysis code, will be made available.
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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.
Olgun Topal, DDS, PhD principal investigator
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Afyonkarahisar Health Sciences University
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 citrate and Behavioral counseling in people with Chronic Masticatory Myofascial Pain, run by Muhammet Yasin Pektaş 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?
The sponsor lists 4 inclusion and 9 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 6 Oct 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. 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?
Masticatory Muscle Pain Intensity (time frame: 3 months after randomization). 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 6 Oct 2026.