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Maxillofacial AbnormalitiesNCT05936476

Impact of Maxillomandibular Deformities on Individuals' Nutritional Status

An observational study of Maxillofacial Abnormalities, run by Marmara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Maxillofacial Abnormalities
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2023to 1 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting

  • Marmara University School of Dentistry

    Istanbul, 34854

    Ferit Bayram, Ph. D., 2167775074, ferit.bayram@marmara.edu.tr

    Murat Tozlu, Assoc. Prof.

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Influence of Different Types of Maxillomandibular Deformities on the Nutritional Status of Individuals: A Cross-sectional Study

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.

Keywords
Orthognathic surgery, Nutritional status, Angles classification
Medical subject headings
Maxillofacial Abnormalities, Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05936476
Study groupRoleWhat they receive
Skeletal Class I (Control Group)Not described
Skeletal Class IIClass 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 IIIClass 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 BiteAnterior 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1

  2. 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.

    Measured: Day 1

Secondary outcomes (6)

  1. Antropometric measurements - Height

    Height will be measured with the participant standing barefoot and upright, with the head, back, and hips touching the wall. Height will be measured with a meter and recorded in centimeters. The measurement will be taken using a wall-mounted stadiometer.

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. Waist Circumference Measurement

    Waist circumference measurement will be taken from the thinnest point of the participant, below the ribs and above the belly. During the measurement, the individual will be standing and exhaling in a relaxed state. The measurement tape will be placed around the waist in a horizontal line and will be measured in cm.

    Measured: Day 1

  4. Body Mass Index Measurement

    The Body Mass Index will be calculated as weight (kg)/height (m2). The WHO classification will be used to categorize: · BMI < 18.5: Underweight · BMI 18.5 - 24.9: Normal · BMI 25.0 - 29.9: Overweight · BMI 30.0 - 34.9: Class I Obesity · BMI 35.0 - 39.

    Measured: Day 1

  5. Physical Activity Level

    The physical activity levels of the individuals included in the study will be evaluated using the short form of the International Physical Activity Questionnaire (IPAQ). The short form of the International Physical Activity Questionnaire (7 questions) is used to evaluate physical activity in 4 areas including leisure time, household, work, and transportation over a seven-day period. Physical activity level is classified as active, moderately active, and inactive based on general scores. The IPAQ short form, developed with the support of the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC), has had its validity and reliability study performed in Turkey by Sağlam et al. It provides information about the time individuals spend in light, moderate, and intense activities, as well as sitting duration.

    Measured: Day 1

  6. Chewing Ability Assessment

    Chewing ability can be evaluated both objectively and subjectively. Subjective evaluation includes assessment using questionnaires and scales, and it is stated that questionnaires are the most effective tools in evaluating chewing ability in complete denture patients. In this study, a questionnaire form consisting of open-ended and closed-ended questions will be used to determine individuals' chewing difficulties. Open-ended questions will inquire about foods that are difficult to chew and the methods used to consume these foods. In follow-up interviews, closed-ended questions about the ability to chew foods previously listed will be asked as "easy to chew", "experiencing some difficulty", "experiencing great difficulty/cannot chew at all". If the individual says "I have a little or a lot of difficulty" in at least two of the hard foods and "a little or a lot of difficulty" in at least four of the soft foods, it will be evaluated as "there is difficulty in chewing".

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start1 Jul 2023
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion1 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05936476
Sponsor's protocol ID
MUDHF_ORT_SBF_01
Status last verified
Jul 2023
First submitted
23 Jun 2023
Last updated
10 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30954305

  • 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.

    PubMed 28267855

  • 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.

    PubMed 25989940

  • 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.

    PubMed 24572039

  • 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.

    PubMed 20004911

  • 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.

    PubMed 19157673

  • 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.

    PubMed 29165107

Questions about this trial

What is this clinical trial studying?

An observational study of Maxillofacial Abnormalities, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dietary Intake Record (24-hour recall method) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05936476, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.

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