Food Reward Circuit Change by Orthodontics

NCT ID: NCT05026411

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eating Disorders Eating Behavior Eating Habit Orthodontic Appliance Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

The radiologist will be blinded to who the films are from and at what stage of the treatment they were taken.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Orthodontic patients

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

Group Type OTHER

T 0 Diffusion Tensor MR

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance images has been taken from 20 individuals with eating disorders before fixed orthodontic treatment

T 1 Diffusion Tensor MR

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance images will be taken from 20 individuals with eating disorders after 12 months of orthodontic treatment.

T 2 Diffusion Tensor MR

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance images will be taken from 20 individuals with eating disorders 6 months after orthodontic treatment finished

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

T 0 Diffusion Tensor MR

Magnetic resonance images has been taken from 20 individuals with eating disorders before fixed orthodontic treatment

Intervention Type DIAGNOSTIC_TEST

T 1 Diffusion Tensor MR

Magnetic resonance images will be taken from 20 individuals with eating disorders after 12 months of orthodontic treatment.

Intervention Type DIAGNOSTIC_TEST

T 2 Diffusion Tensor MR

Magnetic resonance images will be taken from 20 individuals with eating disorders 6 months after orthodontic treatment finished

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Muğla Sıtkı Koçman University

OTHER

Sponsor Role collaborator

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Balikli greek hospital foundation

UNKNOWN

Sponsor Role collaborator

Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Banu Kılıç

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Banu Kılıç

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Banu Kilic

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21277923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27085908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18063337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25263466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9844209 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

119S125

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

bkilic002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Retentive Teeth
NCT05727670 ENROLLING_BY_INVITATION NA