NCT05936476

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

June 23, 2023

Last Update Submit

July 7, 2023

Conditions

Keywords

Orthognathic surgeryNutritional statusAngles classification

Outcome Measures

Primary Outcomes (2)

  • Dietary Intake Record (24-hour recall method)

    This measure involves recalling all the food and beverages consumed by an individual over the previous day. The 24-hour recall will be conducted through detailed questions asked by the researchers of the study to obtain more precise information about the individual's consumption. The collected dietary intake records will be analyzed using the Computer-Assisted Nutrition Program, Nutrition Information Systems Package Program (BEBIS). The quantities of nutrients included in the meals will be calculated using the "Standard Meal Recipes" book, and serving sizes will be determined using the "Food and Meal Photo Catalog" book.

    Day 1

  • Assessment of Diet Quality using Healthy Eating Index (HEI-2015)

    The Healthy Eating Index (HEI) is a tool developed by the USDA's Center for Nutrition Policy and Promotion to assess the quality of an individual's diet. The HEI-2015, the most recent version, consists of 13 components that evaluate both adequacy and moderation of dietary intake. Nine components focus on the consumption of essential nutrients and food groups, including fruits, vegetables, whole grains, dairy, protein foods, and fatty acids. The remaining four components assess the intake of less healthy items, such as refined grains, added sugars, sodium, and saturated fats. Each component is assigned a score, and the total score can range from 0 to 100. Higher scores indicate better adherence to recommended dietary guidelines. The HEI-2015 score is classified into three categories: scores below 50 indicate poor diet quality, scores between 51 and 80 suggest a need for dietary improvements, and scores above 80 indicate good diet quality.

    Day 1

Secondary Outcomes (6)

  • Antropometric measurements - Height

    Day 1

  • Body Composition

    Day 1

  • Waist Circumference Measurement

    Day 1

  • Body Mass Index Measurement

    Day 1

  • Physical Activity Level

    Day 1

  • +1 more secondary outcomes

Study Arms (4)

Skeletal Class I (Control Group)

Skeletal Class II

Class II malocclusion is characterized by the upper jaw (maxilla) being positioned more forward in relation to the lower jaw (mandible), resulting in an overbite.

Skeletal Class III

Class III malocclusion is characterized by the lower jaw (mandible) being positioned more forward in relation to the upper jaw (maxilla), resulting in an underbite.

Anterior Open Bite

Anterior open bite is characterized by a lack of vertical overlap or contact between the upper and lower front teeth when the back teeth are in contact (occlusion).

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4.

    PMID: 30954305BACKGROUND
  • Micha R, Penalvo JL, Cudhea F, Imamura F, Rehm CD, Mozaffarian D. Association Between Dietary Factors and Mortality From Heart Disease, Stroke, and Type 2 Diabetes in the United States. JAMA. 2017 Mar 7;317(9):912-924. doi: 10.1001/jama.2017.0947.

    PMID: 28267855BACKGROUND
  • Backholer K, Spencer E, Gearon E, Magliano DJ, McNaughton SA, Shaw JE, Peeters A. The association between socio-economic position and diet quality in Australian adults. Public Health Nutr. 2016 Feb;19(3):477-85. doi: 10.1017/S1368980015001470. Epub 2015 May 20.

    PMID: 25989940BACKGROUND
  • Reedy J, Krebs-Smith SM, Miller PE, Liese AD, Kahle LL, Park Y, Subar AF. Higher diet quality is associated with decreased risk of all-cause, cardiovascular disease, and cancer mortality among older adults. J Nutr. 2014 Jun;144(6):881-9. doi: 10.3945/jn.113.189407. Epub 2014 Feb 26.

    PMID: 24572039BACKGROUND
  • de Andrade SC, de Azevedo Barros MB, Carandina L, Goldbaum M, Cesar CL, Fisberg RM. Dietary quality index and associated factors among adolescents of the state of Sao Paulo, Brazil. J Pediatr. 2010 Mar;156(3):456-60. doi: 10.1016/j.jpeds.2009.09.066. Epub 2009 Dec 14.

    PMID: 20004911BACKGROUND
  • 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.

    PMID: 19157673BACKGROUND
  • 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.

    PMID: 29165107BACKGROUND

MeSH Terms

Conditions

Maxillofacial AbnormalitiesMalocclusion

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTooth Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
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