Clinical trial
Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D Supplements on Symptoms in Individuals With Myofascial Pain and Vitamin D Deficiency
Name
YYU-10/31.05.2023
Description
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.
Trial arms
Trial start
2022-06-01
Estimated PCD
2023-01-10
Trial end
2023-01-10
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Vitamin D + Occlusal Splint
Other names:
devit-3
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.
Arms:
Diclofenac Sodium + Occlusal Splint
Other names:
Voltaren
Size
40
Primary endpoint
VAS pain score
At baseline
VAS pain score
1 week
VAS pain score
1 mounth
VAS pain score
3 mounth
Painless Unassisted Mouth Opening
At baseline
Painless Unassisted Mouth Opening
1 week
Painless Unassisted Mouth Opening
1 mounth
Painless Unassisted Mouth Opening
3 mounth
Maximum Unassisted Mouth Opening
At baseline
Maximum Unassisted Mouth Opening
1 week
Maximum Unassisted Mouth Opening
1 mounth
Maximum Unassisted Mouth Opening
3 mounth
Maximum Assisted Mouth Opening
At baseline
Maximum Assisted Mouth Opening
1 week
Maximum Assisted Mouth Opening
1 mounth
Maximum Assisted Mouth Opening
3 mounth
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-11-03
1 organization
Organization
Yuzuncu Yıl University