Clinical trial NCT06111573: Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D on Myofascial Pain
Official title: Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D Supplements on Symptoms in Individuals With Myofascial Pain and Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myofascial Pain Dysfunction Syndrome,Temporomandibular Joint
Keywords: temporomandibular joint
vitamin d
myofascial pain
sodium diclofenac
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS pain score
timeFrame: At baseline
measure: VAS pain score
timeFrame: 1 week
measure: VAS pain score
timeFrame: 1 mounth
measure: VAS pain score
timeFrame: 3 mounth
measure: Painless Unassisted Mouth Opening
timeFrame: At baseline
measure: Painless Unassisted Mouth Opening
timeFrame: 1 week
measure: Painless Unassisted Mouth Opening
timeFrame: 1 mounth
measure: Painless Unassisted Mouth Opening
timeFrame: 3 mounth
measure: Maximum Unassisted Mouth Opening
timeFrame: At baseline
measure: Maximum Unassisted Mouth Opening
timeFrame: 1 week
measure: Maximum Unassisted Mouth Opening
timeFrame: 1 mounth
measure: Maximum Unassisted Mouth Opening
timeFrame: 3 mounth
measure: Maximum Assisted Mouth Opening
timeFrame: At baseline
measure: Maximum Assisted Mouth Opening
timeFrame: 1 week
measure: Maximum Assisted Mouth Opening
timeFrame: 1 mounth
measure: Maximum Assisted Mouth Opening
timeFrame: 3 mounth
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yüzüncü Yıl University
Study officials:
References: