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Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D on Myofascial Pain

Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D Supplements on Symptoms in Individuals With Myofascial Pain and Vitamin D Deficiency

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06111573
Enrollment
40
Registered
2023-11-01
Start date
2022-06-01
Completion date
2023-01-10
Last updated
2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain Dysfunction Syndrome,Temporomandibular Joint

Keywords

temporomandibular joint, vitamin d, myofascial pain, sodium diclofenac

Brief summary

It has been reported in the literature that there is a significant relationship between bruxism and low serum vitamin D levels. It was aimed to compare the effectiveness of diclofenac sodium treatment versus vitamin D supplementation on symptoms in individuals with myofascial pain and vitamin D deficiency.

Detailed description

In the current literature, it has been reported that there is a significant relationship between teeth grinding and low serum vitamin D levels. Vitamin D has been shown to play an important role in the musculoskeletal and cardiovascular systems, as well as in the control of calcium and phosphate metabolism and in maintaining adequate blood levels of these minerals. Vitamin D deficiency has been associated with poor physical performance and low muscle strength. There are also studies to understand the relationship between TMJ disorders and vitamin D level (serum 25(OH) D). These studies reported a relationship between the presence of TMJ disorder and vitamin D deficiency. NSAIDs are a large group of drugs that inhibit cyclooxygenases and thus prevent the formation of prostaglandins. Traditionally, it has been the most commonly prescribed group of medications for pain in the orofacial area. It is recommended to use these drugs regularly for at least 2 weeks to achieve an anti-inflammatory effect in individuals with TMJ disorders. It was aimed to compare the effectiveness of diclofenac sodium treatment versus vitamin D supplementation on symptoms in individuals with myofascial pain and vitamin D deficiency.

Interventions

DIETARY_SUPPLEMENTVitamin D

Study group using Vitamin D for myofascial pain treatment. Diagnostic Criteria for Temporomandibular Disorders was used in the diagnosis of patients with myofascial pain. Study group usind Vitamin D for myofascial pain treatment. Medical treatment with Vitamin D (10,000 IU/day) + Occlusal Splint treatment was applied. Occlusal Splints were made of hard acrylic with a flat surface and were used only for 8 hours during sleep for 3 months. 500 mg Paracetamol tablet was prescribed to the patients as a rescue painkiller if they needed painkillers.

DRUGDiclofenac Sodium

Diagnostic Criteria for Temporomandibular Disorders was used in the diagnosis of patients with myofascial pain. Control group using Diclofenac Sodium for myofascial pain treatment. Medical treatment with Diclofenac Sodium (Voltaren 75 mg, 2x1 ) + Occlusal Splint treatment was applied. Occlusal Splints were made of hard acrylic with a flat surface and were used only for 8 hours during sleep for 3 months. 500 mg Paracetamol tablet was prescribed to the patients as a rescue painkiller if they needed painkillers.

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Vitamin D deficiency, * Myofascial pain complaint, * Chronic pain, * No missing teeth, * Absence of open bite and/or crossbite.

Exclusion criteria

* Individuals who have undergone interventional or surgical procedures related to the temporomandibular joint, * Temporomandibular joint pathology, * Pregnancy or breastfeeding, * Individuals who do not come for postoperative checks, * Using different medications other than those recommended, * Allergy to study drugs and materials to be used

Design outcomes

Primary

MeasureTime frameDescription
VAS pain scoreAt baselineA Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Painless Unassisted Mouth OpeningAt baselinePain-free opening e.g. maximum comfortable opening was defined as the maximum distance the subject could open his/her mouth without experiencing any pain and discomfort. After the subject had opened this wide, the examiner measured the distance between the maxillary and mandibular incisal edges.
Maximum Unassisted Mouth OpeningAt baselineMaximum assisted opening was defined as the maximum distance the subject could open the mouth, even if he/she felt pain or discomfort. The interincisal distance between the maxillary and mandibular incisal edges was measured.
Maximum Assisted Mouth OpeningAt baselineMaximum assisted opening was defined as the maximum distance the subject could open the mouth, even if he/she felt pain or discomfort. After the subject had opened this wide, the examiner placed his fingers on the subject's maxillary and mandibular central incisors, and forced the subject's mouth to open wider. The interincisal distance between the maxillary and mandibular incisal edges was measured.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026