Impact of Maxillomandibular Deformities on Individuals' Nutritional Status

July 7, 2023 updated by: Ferit Bayram, Marmara University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34854
        • Recruiting
        • Marmara University School of Dentistry
        • Contact:
        • Principal Investigator:
          • Murat Tozlu, Assoc. Prof.
        • Principal Investigator:
          • Begüm Turan, DDS
        • Principal Investigator:
          • Burcu Kaya, DDS
        • Principal Investigator:
          • Sebiha Nihal Yılmaz, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dietary Intake Record (24-hour recall method)
Time Frame: Day 1
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)
Time Frame: Day 1
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: Day 1
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.
Day 1
Antropometric measurements - Height
Time Frame: Day 1
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.
Day 1
Waist Circumference Measurement
Time Frame: Day 1
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.
Day 1
Body Mass Index Measurement
Time Frame: Day 1
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.
Day 1
Physical Activity Level
Time Frame: Day 1
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.
Day 1
Chewing Ability Assessment
Time Frame: Day 1
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".
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MUDHF_ORT_SBF_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings