The Effect of Clear Aligners and Metal Brackets on the Nutritional Status of Orthodontic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Marmara University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Oral Health Impact Profile-14 (OHIP-14)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Waist Circumference(Day 1)
- Physical Activity Level(Day 1)
- Height Measurement(Day 1)
- Body Composition(Day 1)
Investigators
Ferit Bayram
Assist. Prof.
Marmara University