Nutritional Status in Orthognathic Surgery Patients

NCT05591963 | Completed

• 1 other identifier: MU_DHF_SBF_02
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of orthognathic surgery on nutritional status, anthropometric measurements, food consumption levels, physical activity levels, biochemical parameters, chewing ability and oral-health impact profile.

Conditions

Malocclusion

Keywords

Orthognathic surgery; Malocclusion; Nutritional Status

Outcome Measures

Primary Outcomes (6)

• Change in nutritional status

  The Subjective Global Assessment (SGA) will be used to assess changes in nutritional status. SGA is an easy-to-apply, low-cost and reliable method that is frequently used in the evaluation of malnutrition status. After the patient is evaluated according to certain criteria, the level of malnutrition is determined by the evaluator's subjective point of view. It is a four-part evaluation. These are weight loss and food intake history, gastrointestinal system symptoms, functional capacity, metabolic requirement, and physical examination. The analysis of the information and the results from it are scored as A, B, C. If the patient is well-nourished, he is classified as A, moderately malnourished, B, and severely malnourished, C. SGA will be applied by the researchers in face-to-face meetings within 7 days before the operation, on the 7th day, 15th day, 1st month and 3rd month after the operation.

  3 months

• Change in food consumption

  To evaluate the food consumption of the patients included in the study, at the preop 7 days, postoperative 7th day, 15th day, 1st month and 3rd month will be taken with 24-hour recall method. The amount of nutrients included in the meals will be calculated by using the "Standard Recipes" book, and the measurement amounts will be calculated by using the "Food Photo Catalogue" book. The data obtained from the 24-hour recall method will be analyzed using the "Computer Assisted Nutrition Program, Nutrition Information Systems Package Program (BEBIS)" and the amount of energy, carbohydrates, protein, fat, fiber and micronutrients consumed by participants will be calculated. Intake of energy, macro nutrients, fiber and micronutrients will be compared with the preop 7 days, postoperative 7th day, 15th day, 1st month and 3rd.

  3 months

• Change in chewing ability

  In this study, a questionnaire consisting of open and closed-ended questions will be used to determine the chewing difficulties of individuals. With open-ended questions, foods that are difficult to chew and the methods used to consume these foods will be questioned. In the follow-up interviews, closed-ended questions such as the ability to chew the previously listed foods are "easy to chew", "I have a little difficulty", "I have a lot of difficulty / can't chew at all". If individuals say, "I have a little or a lot of difficulty" while chewing hard foods and "I have some or a lot of difficulty" when chewing soft foods, they will be evaluated as "difficulty in chewing".

  3 months

• Change in body weight

  Body weight will be evaluated during face-to-face interviews with patients in pre-op 7 days and post-op 7th day, 15th day, 1st month and 3rd month with Tanita DC-360 body analyzer. Patients will be asked to remove all metal items (rings, earrings, bracelets, watches, phones, etc.), any heavy clothing, shoes, or socks before stepping on the device. The device was set to -1.0 kg for the remaining clothes.

  3 months

• Change in BMI

  Body Mass Index will be calculated as weight (kg)/height (m2) and will be classified based on the WHO classification. It will be evaluated at pre-op 7 days and post-op 7th day, 15th day, 1st month and 3rd month.

  3 months

• Change in 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. Using this device, the body compositions of the individuals will be recorded in the pre-op 7 days and on the post-op 7th day, 15th day, 1st month and 3rd month.

  3 months

Secondary Outcomes (4)

• Change in physical activity

  3 months

• Change in Oral-Health Impact Profile

  3 months

• Change in pain intensity

  3 months

• Change in Body Circumference Measurements

  3 months

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who applied to the Marmara University Faculty of Dentistry Department of Oral and Maxillofacial Surgery who applied for dentomaxillofacial deformities and needed orthognathic surgery will be included in the study. It is aimed to invite all patients who applied to the clinic to the research.

You may qualify if:

• years old,
• Volunteer to participate in the study,
• Dysgnatic patients with malocclusion who applied to Marmara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery will be included in the study.
• Type of surgery (only patients with genioplasty operation will not be accepted)

You may not qualify if:

• Patients with a history of acute facial trauma,
• Patients with previous facial surgeries,
• Pregnant or lactating women
• Those who have diseases that may cause systemic neuropathy such as diabetes, hypertension, kidney disease,
• Those who do not want to sign the consent form,
• Orthognathic surgery patients treated with genioplasty only,
• Patients with a history of eating disorders (anorexia nervosa, bulimia nervosa, etc.).
• Patients with a history of malignancy, radiotherapy or chemotherapy will be excluded from the study.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 24, 2022
• Study Start: May 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

TU (1)