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

Sponsor

Yuzuncu Yıl University (Other)

Overall Status

Completed

CT.gov ID

NCT06111573

Collaborator

(none)

Enrollment

Location

Arms

7.3

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myofascial Pain Dysfunction Syndrome,Temporomandibular Joint	Dietary Supplement: Vitamin D Drug: Diclofenac Sodium	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2022

Actual Primary Completion Date :

Jan 10, 2023

Actual Study Completion Date :

Jan 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D + Occlusal Splint 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.	Dietary Supplement: Vitamin 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. Other Names: devit-3
Active Comparator: Diclofenac Sodium + Occlusal Splint 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.	Drug: Diclofenac 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. Other Names: Voltaren

Arm

Intervention/Treatment

Experimental: Vitamin D + Occlusal Splint

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.

Dietary Supplement: Vitamin 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.

Other Names:

devit-3

Active Comparator: Diclofenac Sodium + Occlusal Splint

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.

Drug: Diclofenac 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.

Other Names:

Voltaren

Outcome Measures

Primary Outcome Measures

VAS pain score [At baseline]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score [1 week]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score [1 mounth]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score [3 mounth]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Painless Unassisted Mouth Opening [At baseline]
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.
Painless Unassisted Mouth Opening [1 week]
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.
Painless Unassisted Mouth Opening [1 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.
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 [At baseline]
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.
Maximum Unassisted Mouth Opening [1 week]
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.
Maximum Unassisted Mouth Opening [1 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.
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.
Maximum Assisted Mouth Opening [At baseline]
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.
Maximum Assisted Mouth Opening [1 week]
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.
Maximum Assisted Mouth Opening [1 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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