Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D Supplements on Symptoms in Individuals With Myofascial Pain and Vitamin D Deficiency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Painless Unassisted Mouth Opening
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Vitamin D deficiency,
- •Myofascial pain complaint,
- •Chronic pain,
- •No missing teeth,
- •Absence of open bite and/or crossbite.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Vitamin D (Dietary Supplement)
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.
干预措施: Diclofenac Sodium (Drug)
结局指标
主要结局
Painless Unassisted Mouth Opening
时间窗: 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
时间窗: 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
时间窗: 3 mounth
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Maximum Assisted Mouth Opening
时间窗: 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.
次要结局
未报告次要终点
研究者
Serap Keskin Tunc
Associate Professor
Yuzuncu Yıl University