NCT06053723

Brief Summary

The aim of the study was to investigate the effect of bruxism on Temporomanbular joint functionality and dysfunction severity in individuals with Temporomandibular Dysfunction (TMD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

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

April 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

September 19, 2023

Last Update Submit

September 28, 2023

Conditions

Temporomandibular Dysfunction

Keywords

temporomandibular dysfunctionbruxismchewing functionality

Outcome Measures

Primary Outcomes (5)

  • Bruxism evaluation

    Sleep bruxism reported by the individual was recorded. As clinical diagnostic criteria for bruxism; the presence of regular or frequent teeth clenching and grinding sounds followed by pain or fatigue in the jaw muscles on waking up in the morning, temporal headache, masseter muscle hypertrophy, abnormal tooth abrasion and/or jaw locking were questioned and the presence of one or more clinical findings was recorded as bruxism.

    April 2023- September 2023

  • Maximum mouth opening

    Maximum pain-free mouth opening was measured with a 15 cm ruler

    April 2023- September 2023

  • Severity of Temporomandibular dysfunction

    Fonseca's Anamnestic Questionnaire (FAQ) was used. The questionnaire includes 10 questions about joint, head and neck pain, pain during masticatory activity, parafunctional habits, decreased joint motion, impaired occlusion and emotional stress. As a result of the questionnaire, the presence of TMD is accepted in patients with a score of 25 and above, and the severity can be classified as mild TMJ disorder (25-45), moderate TMJ disorder (50-65) and severe TMJ disorder (70-100).

    April 2023- September 2023

  • Pain intensity

    Numeric Pain Scale (NAS): It is a simple, reliable and short-term method commonly used in the clinic to measure pain intensity. The patient is told that the most severe pain he/she feels in the TMJ region is 10, and if there is no pain, the pain intensity is 0. The participant was asked to say a number between 0 and 10 corresponding to the intensity of pain felt in the TMJ region.

    April 2023- September 2023

  • Jaw Functionality

    Jaw Functionality Limitation Scale-20 was used. It includes a total of 20 items, with "0" indicating no limitation and "10" indicating severe limitation in each item, about the function of the TMJ during different activities, difficulty in chewing and jaw limitation. As a result of the questionnaire, it was reported that TMJ function was limited in individuals with a score of 5 and above.

    April 2023- September 2023

Interventions

Fonseca's Anamnestic QuestionnaireOTHER

The questionnaire includes 10 questions about joint, head and neck pain, pain during masticatory activity, parafunctional habits, decreased joint motion, impaired occlusion and emotional stress.

Numeric Pain ScaleOTHER

It is a simple, reliable and short-term method that is frequently used to measure pain intensity in the clinic.

Jaw Functionality Limitation Scale-20OTHER

It includes a total of 20 items, with "0" indicating no limitation and "10" indicating severe limitation in each item, about the function of the TMJ during different activities, difficulty in chewing and jaw limitation.

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

diagnosed with TMD

You may qualify if:

  • Aged between 20 and 55 years,
  • Diagnosed with TMD,
  • volunteer to participate in the study

You may not qualify if:

  • having a non-reduced disc problem,
  • surgical operation due to spine, abdomen and/or TMJ problem,
  • trauma, cancer, neurological problems, congenital anomalies, musculoskeletal system problems,
  • systemic disease,
  • facial paralysis
  • Less than 6 months of receiving any treatment related to the spine and TMJ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandirma Onyedi Eylul University

Balıkesir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersBruxism

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesTooth DiseasesHabitsBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

April 15, 2023

Primary Completion

September 1, 2023

Study Completion

September 15, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

TU(1)