Impact of Clear Aligners and Metal Brackets on Nutritional Status

NCT05936463 | Unknown

• 1 other identifier: MUDHF_ORT_SBF_02
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Keywords

Tooth Crowding; Nutritional Status; Orthodontic Brackets; Clear Aligner Appliances

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Physical Activity Level

  Day 1

• Height Measurement

  Day 1

• Body Composition

  Day 1

• Waist Circumference

  Day 1

Study Arms (2)

Orthodontics brackets

Clear aligner appliances

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 7, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: April 1, 2024
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

TU (1)