Clinical trial NCT05026411: Food Reward Circuit Change by Orthodontics
Official title: Assessment of Food Reward Circuit Change in Individuals Receiving Orthodontic Treatment With Diffusion Tensor Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorders
Eating Behavior
Eating Habit
Orthodontic Appliance Complication
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Muğla Sıtkı Koçman University
name: The Scientific and Technological Research Council of Turkey
name: Balikli greek hospital foundation
First posted: 2021-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Diffusion tensor imagings will be taken from the patients at the beginning of the orthodontic treatment, in the first year of treatment and 6 months after the treatment ends.
Primary purpose: DIAGNOSTIC

Brief summary: It has been described in obese individuals in which decreased basal metabolism as well as dopaminergic changes in the prefrontal cortex and striatum parallels the increased activation of reward brain regions in response to delicious food cues. Our aim is to explore different neurobehavioral dimensions of food choices and motivational processes in the light of this information, and to reveal whether these behaviors can be changed by operant conditioning with neuroimaging methods for phenotypes at risk.

Detailed description: The incidence of eating disorders in society is increasing day by day and is becoming an increasingly serious problem. Overweight people are suggested to exhibit eating behavior to cope with anxiety, depressed mood, anger and other negative emotions. Studies in humans and animals have shown that obesity is associated with changes in dopaminergic neurotransmission. Changes in brain locations associated with satiety and hunger centers (hypothalamus, hippocampal gyrus, amygdala, insula, cerebellum and midbrain) of obese patients have been shown. It has been reported that cognitive control strategies that can lead to more effective impulse control behaviors should be applied for obesity treatment, which is considered as an addiction in which food is perceived as a reward nowadays.

During the first week of fixed orthodontic treatment, all the patients have pain and various discomforts with food, and after each appointment, the pain occurs while chewing. Patients declare having prolonged eating times due to difficulty in chewing, food impaction under the brackets and complains about not being able to consume sugar-containing foods due to maintain oral hygen. It is known that individuals who have eating disorders have a disturbance in their food rewarding properties and eating behavior. They eat in response to emotions rather than to meet energy needs. Pharmacological and bariatric surgical interventions are more successful than dietary lifestyle interventions because these interventions reduced not only the hunger but also the reward value of the homeostatic and hedonic brain regions of the foods. However, there is no study of whether enjoying from the food, perceiving food as a reward or individuals eating habits can be changed. The hypothesis of this study is that as a result of orthodontic treatment in which individuals experience negative emotions during each meal for two years there will be a change in the way of individuals' interpretation of food.

In order to investigate this hypothesis, eating attitudes and eating habit questionnaires will be applied to healthy volunteers with a body mass index of 25 and above chosen from patients who applied to our clinic for fixed orthodontic treatment. Thus, individuals with emotional eating, externally induced eating, restrained eating disorders and eating habits of these individuals will be identified. Magnetic resonance images will be taken from 20 individuals with eating disorders before fixed orthodontic treatment, 12 months of orthodontic treatment and 6 months after orthodontic treatment finished. By means of magnetic resonance imaging (MRI) and diffusion tensor imaging (DTG), the microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. The presence of changes by the orthodontic treatment in nutritional perceptions will be measured.

Eligibility criteria: Inclusion Criteria:

1. Patients thought to have emotional eating, restrained eating and external eating.
2. patients between the ages of 18-60
3. Patients with minor to moderate crowding in the mandibular and maxillary arches not exceeding 7 mm
4. Orthodontic patients who need to be treated with fixed treatment without extraction.
5. Class 1 healthy patients according to the American Society of Anesthesiologists (ASA) criteria 20 individuals selected from amongst will constitute our main sample group.

Exclusion Criteria:

1. Maxillary expansion apparatus, transpalatal arch, Herbst, Forsus etc. before fixed treatment. Patients who require fixed non-treatment devices such as fixed devices will not be included in the study.
2. Patients who require constant use of devices containing materials that may contain steel other than tubes and brackets as orthodontic materials will not be included.
3. Although it could not be detected at the beginning of the treatment if any of the treatment methods (extraction, etc.) other than the standardized protocol are required in the future, the patient will be excluded from the study.
4. Before the patients start orthodontic treatment, a consultation will be requested from the Department of Mental Health and Diseases and the patients who are not found suitable will be excluded from the study by the initiative of the psychiatrist who examines the patient without asking a reason for the doctor-patient confidentiality.
5. Before the patients start orthodontic treatment, a consultation will be requested from the dietician and the patients who are not found suitable will be excluded from the study by the initiative of the dietician who examines the patient without asking a reason for the doctor-patient confidentiality.
6. Before the patients start orthodontic treatment, a consultation will be requested from the internal medicine doctor if there is any doubt that there may be an organic basis for patients to have a high BMI. The patients who are not found suitable will be excluded from the study by the initiative of the internal medicine doctor who examines the patient without asking a reason for the doctor-patient confidentiality.
7. Patients using medical treatment due to a known disease before orthodontic treatment will be excluded from the study.

Primary outcomes:
measure: T0 -T1 DTMR fractional anisotropy change
timeFrame: 12 months
measure: T1-T2 DTMR fractional anisotropy change
timeFrame: 6 months after the end of fixed orthodontic treatment
measure: T0 -T1 DTMR apparent diffusion coefficient change
timeFrame: 12 months
measure: T1-T2 DTMR Apparent diffusion coefficient change
timeFrame: 6 months
measure: T0 -T1 DTMR mean diffusivity change
timeFrame: 12 months
measure: T1-T2 DTMR mean diffusivity change
timeFrame: 6 months
measure: T0 -T1 DTMR Radial diffusivity change
timeFrame: 12 months
measure: T1-T2 DTMR radial diffusivity change
timeFrame: 6 months
Secondary outcomes:
measure: T0-T1 Dutch Eating Behaviour Questionnaire Score Change
timeFrame: 12 months
measure: T1-T2 Dutch Eating Behaviour Questionnaire Score Change
timeFrame: 6 months after the end of fixed orthodontic treatment
measure: T0-T1 Eating Attitude Test Score Change
timeFrame: 12 months
measure: T1-T2 Eating Attitude Test Score Change
timeFrame: 6 Months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Banu Kilic
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Banu Kılıç
role: STUDY_DIRECTOR
References:
citation: Bozan N, Bas M, Asci FH. Psychometric properties of Turkish version of Dutch Eating Behaviour Questionnaire (DEBQ). A preliminary results. Appetite. 2011 Jun;56(3):564-6. doi: 10.1016/j.appet.2011.01.025. Epub 2011 Jan 26.
citation: Kroemer NB, Small DM. Fuel not fun: Reinterpreting attenuated brain responses to reward in obesity. Physiol Behav. 2016 Aug 1;162:37-45. doi: 10.1016/j.physbeh.2016.04.020. Epub 2016 Apr 13.
citation: Alkan A, Sahin I, Keskin L, Cikim AS, Karakas HM, Sigirci A, Erdem G. Diffusion-weighted imaging features of brain in obesity. Magn Reson Imaging. 2008 May;26(4):446-50. doi: 10.1016/j.mri.2007.10.004. Epub 2007 Dec 11.
citation: Garcia-Garcia I, Horstmann A, Jurado MA, Garolera M, Chaudhry SJ, Margulies DS, Villringer A, Neumann J. Reward processing in obesity, substance addiction and non-substance addiction. Obes Rev. 2014 Nov;15(11):853-69. doi: 10.1111/obr.12221. Epub 2014 Sep 29.
citation: Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.