Clinical trial NCT05936476: Impact of Maxillomandibular Deformities on Individuals' Nutritional Status
Official title: Influence of Different Types of Maxillomandibular Deformities on the Nutritional Status of Individuals: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Maxillofacial Abnormalities
Keywords: Orthognathic surgery
Nutritional status
Angles classification
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult individuals aged 18 to 45 years who are citizens of the Republic of Turkey. At the time of enrollment, these individuals should not be undergoing any orthodontic treatment and should have a complete set of teeth, excluding wisdom teeth. They should possess basic reading and writing skills in the Turkish language and be able to comprehend and comply with the instructions for completing the questionnaire. Additionally, their voluntary participation in the study will be required.

Brief summary: This cross-sectional study explores the influence of various types of maxillomandibular deformities on the nutritional status of individuals. Maxillomandibular deformities, which involve the misalignment of the upper and lower jaws, can significantly affect oral functionality, potentially leading to nutritional deficiencies due to compromised food intake. By analyzing the dietary habits and nutritional health of a diverse group of individuals with these deformities, the study seeks to establish the correlation between the severity of the deformity and the individual's nutritional status. Findings from this research can provide a deeper understanding of the additional health risks that maxillomandibular deformities pose and help in the development of nutritional guidelines specifically tailored for individuals suffering from these conditions.


Eligibility criteria: Inclusion Criteria:

* Adults aged between 18 and 45 years old
* Individuals who are not currently undergoing orthodontic treatment and have a complete set of teeth, excluding wisdom teeth.
* Citizens of the Republic of Turkey
* Able to read and write in Turkish language
* Able to understand and follow the questionnaire instructions
* Willing to participate in the study

Exclusion Criteria:

* Individuals above 45 years old
* Unwilling to sign the informed consent for participation in the study
* Unwilling to answer all the questionnaire items
* Individuals with a chronic disease that requires a specific diet
* Individuals with any eating disorders
* Pregnant and/or nursing individuals
* Individuals with cognitive impairment to a degree that would prevent giving clear and accurate responses will be excluded from the study.

Primary outcomes:
measure: Dietary Intake Record (24-hour recall method)
timeFrame: Day 1
measure: Assessment of Diet Quality using Healthy Eating Index (HEI-2015)
timeFrame: Day 1
Secondary outcomes:
measure: Antropometric measurements - Height
timeFrame: Day 1
measure: Body Composition
timeFrame: Day 1
measure: Waist Circumference Measurement
timeFrame: Day 1
measure: Body Mass Index Measurement
timeFrame: Day 1
measure: Physical Activity Level
timeFrame: Day 1
measure: Chewing Ability Assessment
timeFrame: Day 1
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
References:
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citation: Moynihan P, Thomason M, Walls A, Gray-Donald K, Morais JA, Ghanem H, Wollin S, Ellis J, Steele J, Lund J, Feine J. Researching the impact of oral health on diet and nutritional status: methodological issues. J Dent. 2009 Apr;37(4):237-49. doi: 10.1016/j.jdent.2008.12.003. Epub 2009 Jan 20.
citation: Koksal E, Karacil Ermumcu MS, Mortas H. Description of the healthy eating indices-based diet quality in Turkish adults: a cross-sectional study. Environ Health Prev Med. 2017 Mar 20;22(1):12. doi: 10.1186/s12199-017-0613-z.