Clinical trial NCT05936463: Impact of Clear Aligners and Metal Brackets on Nutritional Status
Official title: The Effect of Clear Aligners and Metal Brackets on the Nutritional Status of Orthodontic Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malocclusion
Keywords: Tooth Crowding
Nutritional Status
Orthodontic Brackets
Clear Aligner Appliances
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Chewing Ability Assessment
timeFrame: Day 1
measure: Oral Health Impact Profile-14 (OHIP-14)
timeFrame: Day 1
Secondary outcomes:
measure: Physical Activity Level
timeFrame: Day 1
measure: Height Measurement
timeFrame: Day 1
measure: Body Composition
timeFrame: Day 1
measure: Waist Circumference
timeFrame: Day 1
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
References: