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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Gaziantep

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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