NCT06111573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 26, 2023

Last Update Submit

October 31, 2023

Conditions

Myofascial Pain Dysfunction Syndrome,Temporomandibular Joint

Keywords

temporomandibular jointvitamin dmyofascial painsodium diclofenac

Outcome Measures

Primary Outcomes (16)

  • 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.

    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

Study Arms (2)

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.

Dietary Supplement: Vitamin D

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.

Drug: Diclofenac Sodium

Interventions

Vitamin DDIETARY_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.

Also known as: devit-3
Vitamin D + Occlusal Splint
Diclofenac SodiumDRUG

"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.

Also known as: Voltaren
Diclofenac Sodium + Occlusal Splint

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Vitamin D deficiency,
  • Myofascial pain complaint,
  • Chronic pain,
  • No missing teeth,
  • Absence of open bite and/or crossbite.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl University

Van, 65000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 40883693DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Interventions

Vitamin DDiclofenac

Condition Hierarchy (Ancestors)

Temporomandibular Joint DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 1, 2023

Study Start

June 1, 2022

Primary Completion

January 10, 2023

Study Completion

January 10, 2023

Last Updated

November 3, 2023

Record last verified: 2023-10

Locations

TU(1)