An interventional study of Magnesium citrate and Behavioral counseling in Chronic Masticatory Myofascial Pain, sponsored by Muhammet Yasin Pektaş. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Muhammet Yasin Pektaş · Not applicable, Interventional, and Treatment
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.
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.
This is the only study on the registry with Muhammet Yasin Pektaş as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: Magnesium citrate · Behavioral: Behavioral counseling
Twenty-five participants received a single standardized 30-minute behavioral counseling session. They received no magnesium supplement or placebo.
Behavioral: Behavioral counseling
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.
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.
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.
Time frame: 3 months after randomization
Maximum Unassisted Mouth Opening
Maximum unassisted mouth opening measured in millimeters with a digital caliper. Measurements were obtained in triplicate and averaged for analysis.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the 1-month and 3-month follow-up visits
Plan to share: 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.
Supporting information: Study protocol, Analytic code
No publications or documents are linked to this record.
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