The Relationship of Orthodontic Malocclusions With Temporomandibular Joint Disorders
Investigation of the Relationship of Orthodontic Malocclusions With Temporomandibular Joint Disorders by Helkimo's Indices and Oral Health Impact Profile-14
1 other identifier
observational
250
1 country
1
Brief Summary
The patients who applied to the hospital for orthodontic treatment were asked various questions to evaluate their oral health related quality of life, malocclusions and self reported temporomandibular joint problems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2019
CompletedFirst Submitted
Initial submission to the registry
October 2, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2020
CompletedDecember 3, 2019
December 1, 2019
1 year
October 2, 2019
December 2, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Oral Health Impact Profile
Oral Health Impact Profile relations between patients under 18 and over 18 and between girls and boys
through study completion, an average of 2 months. The scale ranged from 0-5. All data will be summed at the end of the study. Higher values means worse quality of life standard
Helkimo's anamnestic dysfunction index
Helkimo's anamnestic dysfunction index relations between patients under 18 and over 18 and between girls and boys
through study completion, an average of 2 months. The scale ranged from 0-3. Higher scale means worse quality of life standards
Helkimo's clinical dysfunction index
Helkimo's clinical dysfunction index relations between patients under 18 and over 18 and between girls and boys
through study completion, an average of 2 months. The scale ranged from 0-3. Higher scale means worse quality of life standards
Visual analog scale
Visual analog scale relations between patients under 18 and over 18 and between girls and boys. The scale ranged from 0-1. If the patient marked no facial pain the visual analog scale value was accepted as 0, if the patient marked any level of facial pain visual analog scale value was accepted as 1.
through study completion, an average of 2 months.
Study Arms (4)
Oral Health Impact Profile
To evaluate the Oral Health-related Quality of Life, Turkish version of Oral Health Impact Profile-14 was used. Responses were made on a scale 0 (never), 1(hardly ever), 2 (occasionally), 3 (fairly often),and 4 (very often).Oral Health-related Quality of Life impairment was characterized by the Oral Health Impact Profile-14 summary score (the sum of all 14 items, potential range 0-56). Higher Oral Health Impact Profile-14 scores mean worse Oral Health-related Quality of Life and vice versa.
Helkimo's anamnestic dysfunction index
As a method based on patient feedback for the determination of the degree of temporomandibular disorders, anamnestic index was used. For this purpose eight questions were asked to the patients that includes answers as 'yes' or 'no'. (Table 2) The analyses of the questionnaire was done according to anamnestic scale as 0: no symptoms; I: mild symptoms (sensation of the jaw fatigue, jaw stiffness, and temporomandibular joint sounds as clicking or crepitus) and II:severe symptoms (included one or more of the following: Difficulty in the mouth opening, jaw locking, mandible dislocation and its painful movement and painful temporomandibular joint region and/or masticatory muscles)
Visual analog scale (VAS) for facial pain:
Facial pain was measured by asking the patients if they had had any pain during last 12 months and made them mark the intensity of the pain on a visual analog scale which had the anchor points at the left (no pain) and right (worse pain) ends of a 10 cm horizontal line. The analyses of the facial pain was done as fallowing: if the patient marked no facial pain the Visual analog scale value was accepted as 0 and if the patient marked any level of facial pain Visual analog scale value was accepted as 1.
Helkimo's clinical dysfunction index (DI):
Maximum opening of mandible, deviation during opening, dysfunction of temporomandibular joint, pain in the temporomandibular joint and pain in the masticatory muscles was evaluated
Interventions
Patients under 18 years of age
Patients over18 years of age
Girls
Boys
Eligibility Criteria
Patients wish to receive orthodontic treatment in our clinic.
You may qualify if:
- wish to receive orthodontic treatment in our clinic.
You may not qualify if:
- The absence of willingness for the temporomandibular joint and clinical examination or answering the survey questions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziantep University
Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Merve Goymen, PhD
University of Gaziantep
- STUDY CHAIR
Yeşim Kaya
Yuzuncu Yil University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 2, 2019
First Posted
October 10, 2019
Study Start
July 10, 2018
Primary Completion
July 20, 2019
Study Completion
October 20, 2020
Last Updated
December 3, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share