Impact of Clear Aligners and Metal Brackets on Nutritional Status

Malocclusion Clinical Trial

Official title:

The Effect of Clear Aligners and Metal Brackets on the Nutritional Status of Orthodontic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936463
• Other study ID #: MUDHF_ORT_SBF_02
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: July 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Locations

Country	Name	City	State
Turkey	Marmara University School of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Primary	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.	Day 1
Secondary	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 Saglam 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."	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1