MalocclusionNCT05591963
Nutritional Status in Orthognathic Surgery Patients
An observational study of Malocclusion, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Dec 2023
- 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: 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.
Who may be able to join
- 18-45 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Dentistry
Istanbul, 34854
About this study
Official title: Determination of Pre- and Post-Operational Nutritional Status in Orthognathic Surgery Patients
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.
Read the detailed description
Sub-objectives of the study;
- Determining nutritional status changes after orthognathic surgery
- Determining changes in anthropometric measurements (body weight, BMI, fat mass, muscle mass, total body water, waist circumference, hip circumference, mid-upper arm circumference) after orthognathic surgery
- Determining food consumption changes after orthognathic surgery
- Determining changes is physical activity levels after orthognathic surgery
- Determining changes in biochemical parameters 3 months after orthognathic surgery
- Determining changes in chewing ability after orthognathic surgery
- Determining changes in oral-health impact profile after orthognathic surgery
- Determining changes in pain intensity
The aim of this study is to compare these parameters preoperative to postoperative timeline of orthognathic surgery patients.
- Conditions
- Malocclusion
- Keywords
- Orthognathic surgery, Malocclusion, Nutritional Status
- Medical subject headings
- Malocclusion
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (4)
Change in physical activity
The pre-op and post-op physical activity levels of the patients included in the study will be evaluated with the short version of the International Physical Activity Questionnaire (IPAQ), which will be administered at each interview. The International Physical Activity Questionnaire Short Version (7 questions) is used for seven days to assess physical activity in 4 domains, including leisure, indoor, work and transport-related physical activity. Physical activity level is classified as active, mildly active and active according to general scores.
Measured: 3 months
Change in Oral-Health Impact Profile
A scale of 1 to 5 will be used to rate each of the 14 questions about how dental health affects quality of life (minimum score of 0, maximum score of 70). Higher ratings reflect a greater influence of the patient's dental health on their quality of life (higher scores, worse outcomes). At baseline and 3rd month of post-op, the questionnaire will be taken.
Measured: 3 months
Change in pain intensity
Change in muscle pain intensity was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable. The VAS consist of a line which can be presented horizontally or vertically (10 cm long) with anchor points of "no pain" and "worst possible pain". The patient will be asked to put a mark on the line that best describe the pain severity. The patients' responses' will be recorded and scored according to the VAS scale. Then, the results will be compared with the baseline, 1 month and 6 months later.
Measured: 3 months
Change in Body Circumference Measurements
Waist circumference, hip circumference, upper middle arm circumference 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. It will be done by the researcher, using international standards for anthropometric measurements.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 May 2021
- Primary completion1 Jun 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferit Bayram, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591963
- Sponsor's protocol ID
- MU_DHF_SBF_02
- Status last verified
- Jan 2024
- First submitted
- 29 Sep 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Pre- and Post-Operational Nutritional Status in Orthognathic Surgery Patients
- ClinicalTrials.gov ID
- NCT05591963
- Acronym / sponsor ID
- MU_DHF_SBF_02
- Conditions
- Malocclusion
- Keywords
- Orthognathic surgery, Malocclusion, Nutritional Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sub-objectives of the study;
- Determining nutritional status changes after orthognathic surgery
- Determining changes in anthropometric measurements (body weight, BMI, fat mass, muscle mass, total body water, waist circumference, hip circumference, mid-upper arm circumference) after orthognathic surgery
- Determining food consumption changes after orthognathic surgery
- Determining changes is physical activity levels after orthognathic surgery
- Determining changes in biochemical parameters 3 months after orthognathic surgery
- Determining changes in chewing ability after orthognathic surgery
- Determining changes in oral-health impact profile after orthognathic surgery
- Determining changes in pain intensity
The aim of this study is to compare these parameters preoperative to postoperative timeline of orthognathic surgery patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 18-45 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)
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in nutritional status
Time frame: 3 months
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.
Change in food consumption
Time frame: 3 months
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.
Change in chewing ability
Time frame: 3 months
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".
Change in body weight
Time frame: 3 months
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.
Change in BMI
Time frame: 3 months
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.
Change in Body Composition
Time frame: 3 months
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.
4 secondary outcomes
Change in physical activity
Time frame: 3 months
Change in Oral-Health Impact Profile
Time frame: 3 months
Change in pain intensity
Time frame: 3 months
Change in Body Circumference Measurements
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
Related trials for Malocclusion
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
Active, not recruitingObservational study
Customized CBCT-Based Assessment of Transverse Discrepancies
Transverse Skeletal Discrepancy
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Enrolling by invitation
Evaluation of Corticotomy-Assisted Canine Retraction Rate
Malocclusion, Corticotomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 8 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nutritional status (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2024.