MalocclusionNCT05936463
Impact of Clear Aligners and Metal Brackets on Nutritional Status
An observational study of Malocclusion, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of clear aligners and traditional brackets on the nutritional status of orthodontic patients. With the increasing demand for more aesthetic and comfortable orthodontic appliances among adults, clear aligner treatment has gained popularity as an alternative to traditional fixed… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 Apr 2024
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will consist of adult individuals aged 18-45 who are currently undergoing orthodontic treatment and do not have missing teeth (excluding wisdom teeth). They should have been receiving treatment for at least 6 months, be citizens of Turkey, proficient in Turkish language, and willing to participate. Exclusion criteria include age above 45, refusal to provide consent or answer all questions, specific dietary restrictions, eating disorders, pregnancy or breastfeeding, and cognitive impairment.
Who may be able to join
- Adult individuals (18 - 45 years old)
- Undergoing orthodontic treatment, without missing teeth in the mouth (excluding wisdom teeth)
- Having received orthodontic treatment for more than 6 months
- Citizens of the Republic of Turkey
- Proficient in reading and writing in the Turkish language
- Not under the influence of alcohol or drugs
- Able to understand and follow instructions for filling out the questionnaire
- Willing to participate in the study
Who cannot join
- Adult individuals (18 - 45 years old)
- Undergoing orthodontic treatment, without missing teeth in the mouth (excluding wisdom teeth)
- Having received orthodontic treatment for more than 6 months
- Citizens of the Republic of Turkey
- Proficient in reading and writing in the Turkish language
- Not under the influence of alcohol or drugs
- Able to understand and follow instructions for filling out the questionnaire
- Willing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Dentistry
Istanbul, 34854
Murat Tozlu, Ph.D., 2167775000, murat.tozlu@marmara.edu.tr
Ferit Bayram, D.D.S., Ph.D.
About this study
Official title: The Effect of Clear Aligners and Metal Brackets on the Nutritional Status of Orthodontic Patients
This study aims to investigate the effect of clear aligners and traditional brackets on the nutritional status of orthodontic patients. With the increasing demand for more aesthetic and comfortable orthodontic appliances among adults, clear aligner treatment has gained popularity as an alternative to traditional fixed appliances. However, limited research has been conducted to evaluate the impact of clear aligners on dietary habits and nutrition. The study will include adult participants undergoing orthodontic treatment with either clear aligners or traditional brackets. Anthropometric measurements, dietary assessments, and oral health impact evaluations will be conducted to assess the nutritional status of the participants. The findings of this study will contribute to a better understanding of the influence of orthodontic appliances on nutrition and guide clinicians in providing comprehensive care to orthodontic patients.
- Conditions
- Malocclusion
- Keywords
- Tooth Crowding, Nutritional Status, Orthodontic Brackets, Clear Aligner Appliances
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Orthodontics brackets | Not described | |
| Clear aligner appliances | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chewing Ability Assessment
Chewing ability will be evaluated using a questionnaire to assess both subjective and objective aspects. The questionnaire will consist of open-ended and closed-ended questions to determine individuals' chewing difficulties. Open-ended questions will focus on identifying specific foods that present challenges during chewing and the strategies employed to consume these foods. In subsequent follow-up interviews, closed-ended questions will be used to evaluate the ability to chew the previously listed foods, with response options such as "easy to chew," "experiencing some difficulty," and "experiencing great difficulty/cannot chew at all." If participants indicate experiencing slight or significant difficulty chewing at least two of the hard foods and four of the soft foods, it will be considered indicative of chewing difficulties. This assessment will provide valuable insights into the participants' chewing function and its impact on their dietary habits and oral health.
Measured: Day 1
Oral Health Impact Profile-14 (OHIP-14)
The Oral Health Impact Profile-14 (OHIP-14) is a measurement tool developed to assess the impact of oral and dental health on individuals. It consists of 14 questions, and each question is rated on a scale of 0 to 4, with response options defined on a Likert scale as "0=never, 1=rarely, 2=sometimes, 3=often, and 4=always." The total score of OHIP-14 ranges from 0 to 56. A higher total score indicates increased severity of problems and decreased quality of life. In this study, OHIP-14 will be administered to participants to evaluate the impact of oral health on their daily functioning, well-being, and quality of life.
Measured: Day 1
Secondary outcomes (4)
Physical Activity Level
Physical activity levels of participants will be assessed using the International Physical Activity Questionnaire (IPAQ) short form. The IPAQ was developed with the support of the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), and its validity and reliability study was conducted in Turkey in 2010 by Sağlam et al. Individual Metabolic Equivalent Task (MET) scores will be calculated based on the IPAQ protocol to categorize participants into "low, moderate, and high activity levels." Total scores ranging from 0 to 600 will be classified as "low level," scores between 600 and 1500 or 3000 (depending on the number of days of moderate and vigorous physical activity per week) will be classified as "moderate level," and scores equal to or above 1500 or 3000 (depending on the number of days of moderate and vigorous physical activity per week) will be classified as "high level."
Measured: Day 1
Height Measurement
The participants' height will be measured using standard procedures with the participants standing upright, heels together, head in an upright position, and looking straight ahead.
Measured: Day 1
Body Composition
Body composition analysis will be performed with the Tanita DC-360 device that performs bioelectrical impedance analysis (BIA). The analysis report includes body weight (kg), body water mass (kg), body fat mass (kg) and body muscle mass (kg). This method is non-invasive and provides body composition data in less than 1 minute of measurement.
Measured: Day 1
Waist Circumference
Waist circumference will be measured using a flexible tape measure placed horizontally around the smallest circumference between the lower rib and the iliac crest, parallel to the floor passing through the navel.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferit Bayram, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936463
- Sponsor's protocol ID
- MUDHF_ORT_SBF_02
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clear Aligners and Metal Brackets on the Nutritional Status of Orthodontic Patients
- ClinicalTrials.gov ID
- NCT05936463
- Acronym / sponsor ID
- MUDHF_ORT_SBF_02
- Conditions
- Malocclusion
- Keywords
- Tooth Crowding, Nutritional Status, Orthodontic Brackets, Clear Aligner Appliances
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 7 Jul 2023 (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.
This study aims to investigate the effect of clear aligners and traditional brackets on the nutritional status of orthodontic patients. With the increasing demand for more aesthetic and comfortable orthodontic appliances among adults, clear aligner treatment has gained popularity as an alternative to traditional fixed appliances. However, limited research has been conducted to evaluate the impact of clear aligners on dietary habits and nutrition. The study will include adult participants undergoing orthodontic treatment with either clear aligners or traditional brackets. Anthropometric measurements, dietary assessments, and oral health impact evaluations will be conducted to assess the nutritional status of the participants. The findings of this study will contribute to a better understanding of the influence of orthodontic appliances on nutrition and guide clinicians in providing comprehensive care to orthodontic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthodontics brackets | – | – |
| Clear aligner appliances | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will consist of adult individuals aged 18-45 who are currently undergoing orthodontic treatment and do not have missing teeth (excluding wisdom teeth). They should have been receiving treatment for at least 6 months, be citizens of Turkey, proficient in Turkish language, and willing to participate. Exclusion criteria include age above 45, refusal to provide consent or answer all questions, specific dietary restrictions, eating disorders, pregnancy or breastfeeding, and cognitive impairment.
Key inclusion criteria (8 listed)
- Adult individuals (18 - 45 years old)
- Undergoing orthodontic treatment, without missing teeth in the mouth (excluding wisdom teeth)
- Having received orthodontic treatment for more than 6 months
- Citizens of the Republic of Turkey
- Proficient in reading and writing in the Turkish language
Key exclusion criteria (8 listed)
- Adult individuals (18 - 45 years old)
- Undergoing orthodontic treatment, without missing teeth in the mouth (excluding wisdom teeth)
- Having received orthodontic treatment for more than 6 months
- Citizens of the Republic of Turkey
- Proficient in reading and writing in the Turkish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chewing Ability Assessment
Time frame: Day 1
Chewing ability will be evaluated using a questionnaire to assess both subjective and objective aspects. The questionnaire will consist of open-ended and closed-ended questions to determine individuals' chewing difficulties. Open-ended questions will focus on identifying specific foods that present challenges during chewing and the strategies employed to consume these foods. In subsequent follow-up interviews, closed-ended questions will be used to evaluate the ability to chew the previously listed foods, with response options such as "easy to chew," "experiencing some difficulty," and "experiencing great difficulty/cannot chew at all." If participants indicate experiencing slight or significant difficulty chewing at least two of the hard foods and four of the soft foods, it will be considered indicative of chewing difficulties. This assessment will provide valuable insights into the participants' chewing function and its impact on their dietary habits and oral health.
Oral Health Impact Profile-14 (OHIP-14)
Time frame: Day 1
The Oral Health Impact Profile-14 (OHIP-14) is a measurement tool developed to assess the impact of oral and dental health on individuals. It consists of 14 questions, and each question is rated on a scale of 0 to 4, with response options defined on a Likert scale as "0=never, 1=rarely, 2=sometimes, 3=often, and 4=always." The total score of OHIP-14 ranges from 0 to 56. A higher total score indicates increased severity of problems and decreased quality of life. In this study, OHIP-14 will be administered to participants to evaluate the impact of oral health on their daily functioning, well-being, and quality of life.
4 secondary outcomes
Physical Activity Level
Time frame: Day 1
Height Measurement
Time frame: Day 1
Body Composition
Time frame: Day 1
Waist Circumference
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Marmara University School of Dentistry
Istanbul, Turkey (Türkiye)
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 Malocclusion, run by Marmara University 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 8 inclusion and 8 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 10 Jul 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chewing Ability Assessment (time frame: Day 1). The study lists 2 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 10 Jul 2023.