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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D + Occlusal Splint | Experimental | 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. |
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| Diclofenac Sodium + Occlusal Splint | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| VAS pain score | A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10. | At baseline |
| VAS pain score | A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10. | 1 week |
| VAS pain score | A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10. | 1 mounth |
| VAS pain score | A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10. | 3 mounth |
| Painless Unassisted Mouth Opening | 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. | At baseline |
| Painless Unassisted Mouth Opening | 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. | 1 week |
| Painless Unassisted Mouth Opening | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yüzüncü Yıl University | Van | 65000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40883693 | Derived | Kahraman NH, Tunc SK. Comparative evaluation of the effects of diclofenac sodium and vitamin D supplementation on symptoms in individuals with myofascial pain and vitamin D deficiency: a randomized controlled clinical trial. BMC Oral Health. 2025 Aug 29;25(1):1383. doi: 10.1186/s12903-025-06729-1. |
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| ID | Term |
|---|---|
| D013706 | Temporomandibular Joint Dysfunction Syndrome |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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|
| Diclofenac Sodium | Drug | "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. |
|
|
| 1 mounth |
| Painless Unassisted Mouth Opening | 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. | 3 mounth |
| Maximum Unassisted Mouth Opening | 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. | At baseline |
| Maximum Unassisted Mouth Opening | 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. | 1 week |
| Maximum Unassisted Mouth Opening | 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. | 1 mounth |
| Maximum Unassisted Mouth Opening | 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. | 3 mounth |
| Maximum Assisted Mouth Opening | 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. | At baseline |
| Maximum Assisted Mouth Opening | 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. | 1 week |
| Maximum Assisted Mouth Opening | 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. | 1 mounth |
| Maximum Assisted Mouth Opening | 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. | 3 mounth |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009209 | Myofascial Pain Syndromes |
| D009057 | Stomatognathic Diseases |
| D010648 |
| Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |