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

Phase 4

Completed

• Conditions: Myofascial Pain Dysfunction Syndrome,Temporomandibular Joint
• Interventions: Dietary Supplement: Vitamin D; Drug: Diclofenac Sodium

• Registration Number: NCT06111573
• Lead Sponsor: Yuzuncu Yıl University

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.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-01-10
• Study Completion: 2023-01-10
• Status Verified: 2023-10
• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-26
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vitamin D + Occlusal Splint	Vitamin D	Vitamin D is a fat-soluble secosteroid. Vitamin D is very important in muscle and bone metabolism. Vitamin D is a vitamin with some anti-inflammatory and immune-modulating properties.
Diclofenac Sodium + Occlusal Splint	Diclofenac Sodium	Diclofenac Sodium is a type of NSAID which has been found effective both as an analgesic and in reducing inflammation and is classified as weak and preferentially COX-2 selective.

Primary Outcome Measures

Name	Time	Method
Painless Unassisted Mouth Opening	3 mounth	Pain-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 Opening	3 mounth	Maximum 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.
VAS pain score	3 mounth	A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Maximum Assisted Mouth Opening	3 mounth	Maximum 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.

Trial Locations

Locations (1)

Van Yüzüncü Yıl University; 🇹🇷 Van, Turkey