Temporomandibular Joint DisordersNCT04123236
The Relationship of Orthodontic Malocclusions With Temporomandibular Joint Disorders
An observational study of Temporomandibular Joint Disorders, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 27 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Age 0-18, Age 18-26 and Girls
- Type of treatment
- Pill or oral medicine
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2018to 20 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients wish to receive orthodontic treatment in our clinic.
Who may be able to join
- wish to receive orthodontic treatment in our clinic.
Who cannot join
- The absence of willingness for the temporomandibular joint and clinical examination or answering the survey questions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Şehitkamil, 27310
About this study
Official title: 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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Age 0-18, Age 18-26, Girls, Boys
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Age 0-18Other
Patients under 18 years of age
Age 18-26Other
Patients over18 years of age
GirlsOther
Girls
BoysOther
Boys
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Age 0-18; Other: Age 18-26; Other: Girls; Other: 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) Receives: Other: Age 0-18; Other: Age 18-26; Other: Girls; Other: 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. Receives: Other: Age 0-18; Other: Age 18-26; Other: Girls; Other: 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 Receives: Other: Age 0-18; Other: Age 18-26; Other: Girls; Other: Boys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health Impact Profile
Oral Health Impact Profile relations between patients under 18 and over 18 and between girls and boys
Measured: 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
Measured: 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
Measured: 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.
Measured: through study completion, an average of 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start10 Jul 2018
- Primary completion20 Jul 2019
- Study completion20 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Gulec, University of Gaziantep
- Investigators
- Merve Goymen, PhD, Study chair, University of GaziantepYeşim Kaya, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123236
- Sponsor's protocol ID
- 81
- Status last verified
- Dec 2019
- First submitted
- 2 Oct 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship of Orthodontic Malocclusions With Temporomandibular Joint Disorders by Helkimo's Indices and Oral Health Impact Profile-14
- ClinicalTrials.gov ID
- NCT04123236
- Acronym / sponsor ID
- 81
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Oct 2020 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Health Impact Profile | – | Other: Age 0-18, Other: Age 18-26, Other: Girls, Other: BoysTo 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 | – | Other: Age 0-18, Other: Age 18-26, Other: Girls, Other: BoysAs 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: | – | Other: Age 0-18, Other: Age 18-26, Other: Girls, Other: BoysFacial 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): | – | Other: Age 0-18, Other: Age 18-26, Other: Girls, Other: BoysMaximum opening of mandible, deviation during opening, dysfunction of temporomandibular joint, pain in the temporomandibular joint and pain in the masticatory muscles was evaluated |
Who may qualify
- Ages
- 12 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients wish to receive orthodontic treatment in our clinic.
Key inclusion criteria (1 listed)
- wish to receive orthodontic treatment in our clinic.
Key exclusion criteria (1 listed)
- The absence of willingness for the temporomandibular joint and clinical examination or answering the survey questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Age 0-18Patients under 18 years of age | Other | Helkimo's anamnestic dysfunction index, Helkimo's clinical dysfunction index (DI):, Oral Health Impact Profile, Visual analog scale (VAS) for facial pain: |
| Age 18-26Patients over18 years of age | Other | Helkimo's anamnestic dysfunction index, Helkimo's clinical dysfunction index (DI):, Oral Health Impact Profile, Visual analog scale (VAS) for facial pain: |
| GirlsGirls | Other | Helkimo's anamnestic dysfunction index, Helkimo's clinical dysfunction index (DI):, Oral Health Impact Profile, Visual analog scale (VAS) for facial pain: |
| BoysBoys | Other | Helkimo's anamnestic dysfunction index, Helkimo's clinical dysfunction index (DI):, Oral Health Impact Profile, Visual analog scale (VAS) for facial pain: |
Primary outcome
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
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
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Goymen, PhD study chair
University of Gaziantep
Yeşim Kaya study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.