The Relationship of Orthodontic Malocclusions With Temporomandibular Joint Disorders

December 2, 2019 updated by: Aysegul Gulec, University of Gaziantep

Investigation of the Relationship of Orthodontic Malocclusions With Temporomandibular Joint Disorders by Helkimo's Indices and Oral Health Impact Profile-14

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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. For this purposes Oral Health Impact Profile-14, and Helkimo's indexes were used.The relationship between these results were investigated.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Şehitkamil
      • Gaziantep, Şehitkamil, Turkey, 27310
        • Gaziantep University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 27 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients wish to receive orthodontic treatment in our clinic.

Description

Inclusion Criteria:

  • wish to receive orthodontic treatment in our clinic.

Exclusion Criteria:

  • The absence of willingness for the temporomandibular joint and clinical examination or answering the survey questions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Age 0-18
Patients under 18 years of age
Other: Age 18-26
Patients over18 years of age
Other: Girls
Girls
Other: Boys
Boys
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)
Other: Age 0-18
Patients under 18 years of age
Other: Age 18-26
Patients over18 years of age
Other: Girls
Girls
Other: Boys
Boys
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.
Other: Age 0-18
Patients under 18 years of age
Other: Age 18-26
Patients over18 years of age
Other: Girls
Girls
Other: Boys
Boys
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
Other: Age 0-18
Patients under 18 years of age
Other: Age 18-26
Patients over18 years of age
Other: Girls
Girls
Other: Boys
Boys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Health Impact Profile
Time Frame: 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
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
Time Frame: through study completion, an average of 2 months. The scale ranged from 0-3. Higher scale means worse quality of life standards
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
Time Frame: 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 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
Time Frame: through study completion, an average of 2 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Gaziantep

Investigators

  • Study Chair: Merve Goymen, PhD, University of Gaziantep
  • Study Chair: Yeşim Kaya, Yuzuncu Yıl University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 10, 2018

Primary Completion (ACTUAL)

July 20, 2019

Study Completion (ANTICIPATED)

October 20, 2020

Study Registration Dates

First Submitted

October 2, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (ACTUAL)

October 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Temporomandibular Joint Disorders

Clinical Trials on Age 0-18

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe