An observational study in Maxillofacial Abnormalities, sponsored by Marmara University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Marmara University · Observational
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.
21 studies on the registry are indexed under Maxillofacial Abnormalities; 2 are open to participants now.
Browse Maxillofacial Abnormalities studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 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).
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.
Time frame: 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.
Time frame: Day 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.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
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".
Time frame: Day 1
Plan to share: Undecided
Started Jul 2023 (actual). Primary completion is estimated for Dec 2023, 5 months after the start.
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