Eating Disorder NOSNCT07896707
ASSESSMENT OF ORAL HEALTH AND ORAL HEALTH-RELATED QUALITY OF LIFE IN PATIENTS AGED 12-18 YEARS WITH EATING DISORDERS
An observational study of Eating Disorder NOS, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Although numerous instruments are available to assess oral health-related quality of life (OHRQoL) in adults, there is a paucity of studies evaluating the impact of oral health on quality of life in children and adolescents. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder NOS
- What is being tested?
- general oral health interventions and scales
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 20 Oct 2026
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population consists of children and adolescents aged between 12 and 18 years. The population is divided into two groups: a study group and a control group. The study group comprises children and adolescents diagnosed with eating disorders (anorexia nervosa and/or bulimia nervosa) according to DSM-5 criteria, who were referred to and followed at the Child and Adolescent Psychiatry Clinic of Ondokuz Mayıs University Faculty of Medicine. The control group consists of physically and psychologically healthy children and adolescents without any diagnosis of eating disorders or other psychiatric disorders, who presented to the Faculty of Dentistry of Ondokuz Mayıs University. Participants in both groups were selected within the 12-18 age range in accordance with the predefined inclusion and exclusion criteria. The study population includes only individuals for whom written informed consent was obtained from parents or legal guardians and assent was obtained from the children or a
Who may be able to join
- Study Group (Eating Disorder Group):
- Children and adolescents aged between 12 and 18 years.
- A clinical diagnosis of an eating disorder (including anorexia nervosa and/or bulimia nervosa) established by a child and adolescent psychiatrist according to DSM-5 criteria.
- Follow-up at the Child and Adolescent Psychiatry Clinic of Ondokuz Mayıs University Faculty of Medicine.
- Ability to cooperate with clinical oral examination procedures.
- Provision of written informed consent by parents or legal guardians and assent by the child/adolescent.
Show all 14Show fewer
- Control Group:
- Children and adolescents aged between 12 and 18 years.
- Absence of any current or previous diagnosis of an eating disorder.
- Absence of diagnosed psychiatric disorders as determined by medical history.
- Physical and psychological health status deemed normal.
- Referral to the Faculty of Dentistry of Ondokuz Mayıs University for routine dental examination or treatment.
- Ability to cooperate with clinical oral examination procedures.
- Provision of written informed consent by parents or legal guardians and assent by the child/adolescent.
Who cannot join
- Presence of systemic diseases or medical conditions known to affect oral health (e.g., diabetes mellitus, congenital metabolic disorders, autoimmune diseases).
- History of medications that may influence salivary flow, dental hard tissues, or gingival health (e.g., long-term corticosteroids, antiepileptic drugs, antidepressants causing xerostomia).
- Presence of syndromic conditions or developmental disorders affecting craniofacial structures.
- Ongoing orthodontic treatment or presence of fixed orthodontic appliances.
- History of maxillofacial trauma or oral surgery within the last six months.
- Use of removable prosthetic appliances.
- Inability or unwillingness of the child/adolescent or legal guardian to provide informed consent/assent.
- Incomplete questionnaire data or inability to complete the OHIP-14 questionnaire.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55200
About this study
Official title: ASSESSMENT OF ORAL HEALTH AND ORAL HEALTH-RELATED QUALITY OF LIFE IN PATIENTS AGED 12-18 YEARS WITH EATING DISORDERS.
Although numerous instruments are available to assess oral health-related quality of life (OHRQoL) in adults, there is a paucity of studies evaluating the impact of oral health on quality of life in children and adolescents. In Türkiye, no study has been conducted to assess oral health-related quality of life in patients with eating disorders.
The aim of this study is to evaluate and compare the oral health status of individuals diagnosed with eating disorders and healthy individuals without an eating disorder diagnosis using various clinical indices, as well as to assess oral health-related quality of life through questionnaires completed by both patients and their parents.
At the conclusion of the study, the treatment needs of the patients will be communicated to both the patients and their parents, and the patients will be referred to the departments of pediatric dentistry and other relevant specialties at a university hospital to receive the necessary dental treatments.
Read the detailed description
Eating disorders are serious psychiatric conditions associated with substantial morbidity and mortality, leading to significant impairments in somatic health and psychosocial functioning (1). Anorexia nervosa and bulimia nervosa are eating disorders characterized by an intense fear of weight gain, maladaptive weight control behaviors, and marked disturbances in body image (2). Because many of these complications can adversely affect quality of life and the overall management of eating disorders, it is essential to understand, monitor, and treat their secondary mental, systemic, and oral health-related effects (3).
Eating disorders are characterized by alterations in eating behaviors that may lead to deterioration in oral health and damage to dental hard tissues (4). However, the existing literature includes only a limited number of reports focusing on oral health outcomes in patients diagnosed with eating disorders at the age of 20 years (5,6). Oral diseases, such as dental caries and periodontal conditions, have physical, economic, social, and psychological consequences and may negatively affect oral function and overall quality of life (7).
Oral health-related quality of life (OHRQoL) refers to an individual's perception of the impact of oral health on daily life and encompasses the effects of oral conditions on functional capacity as well as emotional and social well-being (8). Previous studies have demonstrated a strong association between dental caries and OHRQoL in children (9). However, no studies conducted in Türkiye have evaluated OHRQoL in patients with eating disorders.
Therefore, by assessing the oral health status of patients with eating disorders using established oral health parameters reported in the literature and comparing OHRQoL outcomes with those of healthy controls, this study aims to contribute to the existing literature by providing a comparative evaluation of oral health status within the framework of OHRQoL in patients with eating disorders.
- Conditions
- Eating Disorder NOS
- Being tested
- general oral health interventions and scales
- Keywords
- quality of life, eating disorder, oral health
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general oral health interventions and scalesOther
Also called plate index, gingival index, DMFT, CAST
What distinguishes this study from others is the nature of the control group and the fact that the specified scales are used together for the first time.The study group consists of children and adolescents diagnosed with eating disorders who were referred to the Child and Adolescent Psychiatry Clinic of Ondokuz Mayıs University Faculty of Medicine. The control group comprises physically and psychologically healthy children and adolescents who presented to the Faculty of Dentistry of Ondokuz Mayıs University. Participants in both groups will be selected within the age range of 12-18 years.
All participating children, adolescents, and their legal guardians will be informed both verbally and in writing about the aim of the study, participation criteria, applied procedures, potential benefits, and possible risks. In addition, a questionnaire assessing sociodemographic characteristics, nutrition-related factors, dietary habits, and oral hygiene practices will be completed jointly by the ch
| Study group | Role | What they receive |
|---|---|---|
| 1. group | Study Group (Eating Disorder Group) Receives: Other: general oral health interventions and scales | |
| 2. group | Control Group (healthy group without eating disorders) Receives: Other: general oral health interventions and scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health-Related Quality of Life (OHRQoL)
The primary outcome measure of this study is the assessment of oral health-related quality of life in children and adolescents with eating disorders compared with healthy controls. Oral health-related quality of life will be evaluated using the Oral Health Impact Profile-14 (OHIP-14) questionnaire, and group comparisons will be performed based on total OHIP-14 scores. Higher OHIP-14 scores indicate increased severity of oral health problems and poorer quality of life.
Measured: Through study completion, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 May 2026
- Primary completion15 May 2026
- Study completion20 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating Disorder NOSStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Buse Kaplan, Ondokuz Mayıs University
- Investigators
- elif buse k kaplan, research assistant, Principal investigator, Ondokuz Mayıs Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896707
- Sponsor's protocol ID
- OndokusMU2.
- Status last verified
- May 2026
- First submitted
- 2 Jan 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1) Mitchell JE. Medical comorbidity and medical complications associated with binge-eating disorder. Int J Eat Disord. 2016;49(3):319-23. 2) Castillo M, Weiselberg E. Bulimia nervosa/purging disorder. Curr Probl Pediatr Adolesc Health Care. 2017 Apr;47(4):85-94. 3) Galmiche M, Déchelotte P, Lambert G, Tavolacci MP. Prevalence of eating disorders over the 2000-2018 period: a systematic literature review. Am J Clin Nutr. 2019 May;109(5):1402-13. 4) Garbin CAS, Martins RJ, Belila NM, Garbin AJI. Oral manifestations in patients with anorexia and bulimia nervosa: a systematic review. J Public Health. 2019;28:765-71. 5) Andrade R, Gonçalves-Pinho M, Roma-Torres A, Brandão I. Treatment of anorexia nervosa: the importance of disease progression in the prognosis. Acta Med Portuguesa. (2017) 30:517-23. doi: 10.20344/amp.8963 6) Resmark G, Herpertz S, Herpertz-Dahlmann B, Zeeck A. Treatment of anorexia nervosa-new evidence-based guidelines. J Clin Med. (2019) 8:153. doi: 10.3390/jcm8020153 7) Naito M, Yuasa H, Nomura Y, Nakayama T, Hamajima N, Hanada N. Oral health status and health-related quality of life: a systematic review. J Oral Sci. 2006;48(1):1-7. 8) Kragt L, van der Tas JT, Moll HA, et al. Early caries predicts low oral health-related quality of life at a later age. Caries Res. 2016;50(5):471-479. 9) Chaffee BW, Rodrigues PH, Kramer PF, Vitolo MR, Feldens CA. Oral health-related quality-of-life scores differ by socioeconomic status and caries experience. Community Dent Oral Epidemiol. 2017;45(3):216-224 10) Allen PF (2003). Sep 08. Assessment of oral health related quality of life. Health Qual Life Outcomes 1: 40 11) Hellstrom, I. (1977). Oral complications in anorexia nervosa. Scand J Dent Res. 8: 71-76 12) Hurst, P.S., LACEY, L.H., CRİSP, A.H. (1977). Teeth, vomiting and diet: a study of the dental characteristics of seventeen anorexia nervosa patients. Postgrad Med J., 53: 298-305. 13) Bartlett D, Ganss C, Lussi A. Basic Erosive Wear Examination (BEWE): a new scori
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF ORAL HEALTH AND ORAL HEALTH-RELATED QUALITY OF LIFE IN PATIENTS AGED 12-18 YEARS WITH EATING DISORDERS.
- ClinicalTrials.gov ID
- NCT07896707
- Acronym / sponsor ID
- OndokusMU2.
- Conditions
- Eating Disorder NOS
- Keywords
- quality of life, eating disorder, oral health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 20 Oct 2026 (actual)
- First posted
- 27 Oct 2026 (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.
Although numerous instruments are available to assess oral health-related quality of life (OHRQoL) in adults, there is a paucity of studies evaluating the impact of oral health on quality of life in children and adolescents. In Türkiye, no study has been conducted to assess oral health-related quality of life in patients with eating disorders.
The aim of this study is to evaluate and compare the oral health status of individuals diagnosed with eating disorders and healthy individuals without an eating disorder diagnosis using various clinical indices, as well as to assess oral health-related quality of life through questionnaires completed by both patients and their parents.
At the conclusion of the study, the treatment needs of the patients will be communicated to both the patients and their parents, and the patients will be referred to the departments of pediatric dentistry and other relevant specialties at a university hospital to receive the necessary dental treatments.
Detailed description
Eating disorders are serious psychiatric conditions associated with substantial morbidity and mortality, leading to significant impairments in somatic health and psychosocial functioning (1). Anorexia nervosa and bulimia nervosa are eating disorders characterized by an intense fear of weight gain, maladaptive weight control behaviors, and marked disturbances in body image (2). Because many of these complications can adversely affect quality of life and the overall management of eating disorders, it is essential to understand, monitor, and treat their secondary mental, systemic, and oral health-related effects (3).
Eating disorders are characterized by alterations in eating behaviors that may lead to deterioration in oral health and damage to dental hard tissues (4). However, the existing literature includes only a limited number of reports focusing on oral health outcomes in patients diagnosed with eating disorders at the age of 20 years (5,6). Oral diseases, such as dental caries and periodontal conditions, have physical, economic, social, and psychological consequences and may negatively affect oral function and overall quality of life (7).
Oral health-related quality of life (OHRQoL) refers to an individual's perception of the impact of oral health on daily life and encompasses the effects of oral conditions on functional capacity as well as emotional and social well-being (8). Previous studies have demonstrated a strong association between dental caries and OHRQoL in children (9). However, no studies conducted in Türkiye have evaluated OHRQoL in patients with eating disorders.
Therefore, by assessing the oral health status of patients with eating disorders using established oral health parameters reported in the literature and comparing OHRQoL outcomes with those of healthy controls, this study aims to contribute to the existing literature by providing a comparative evaluation of oral health status within the framework of OHRQoL in patients with eating disorders.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. group | – | Other: general oral health interventions and scalesStudy Group (Eating Disorder Group) |
| 2. group | – | Other: general oral health interventions and scalesControl Group (healthy group without eating disorders) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of children and adolescents aged between 12 and 18 years. The population is divided into two groups: a study group and a control group. The study group comprises children and adolescents diagnosed with eating disorders (anorexia nervosa and/or bulimia nervosa) according to DSM-5 criteria, who were referred to and followed at the Child and Adolescent Psychiatry Clinic of Ondokuz Mayıs University Faculty of Medicine. The control group consists of physically and psychologically healthy children and adolescents without any diagnosis of eating disorders or other psychiatric disorders, who presented to the Faculty of Dentistry of Ondokuz Mayıs University. Participants in both groups were selected within the 12-18 age range in accordance with the predefined inclusion and exclusion criteria. The study population includes only individuals for whom written informed consent was obtained from parents or legal guardians and assent was obtained from the children or a
Key inclusion criteria (14 listed)
- Study Group (Eating Disorder Group):
- Children and adolescents aged between 12 and 18 years.
- A clinical diagnosis of an eating disorder (including anorexia nervosa and/or bulimia nervosa) established by a child and adolescent psychiatrist according to DSM-5 criteria.
- Follow-up at the Child and Adolescent Psychiatry Clinic of Ondokuz Mayıs University Faculty of Medicine.
- Ability to cooperate with clinical oral examination procedures.
Key exclusion criteria (8 listed)
- Presence of systemic diseases or medical conditions known to affect oral health (e.g., diabetes mellitus, congenital metabolic disorders, autoimmune diseases).
- History of medications that may influence salivary flow, dental hard tissues, or gingival health (e.g., long-term corticosteroids, antiepileptic drugs, antidepressants causing xerostomia).
- Presence of syndromic conditions or developmental disorders affecting craniofacial structures.
- Ongoing orthodontic treatment or presence of fixed orthodontic appliances.
- History of maxillofacial trauma or oral surgery within the last six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general oral health interventions and scalesAlso: plate index, gingival index, DMFT, CASTWhat distinguishes this study from others is the nature of the control group and the fact that the specified scales are used together for the first time.The study group consists of children and adolescents diagnosed with eating disorders who were referred to the Child and Adolescent Psychiatry Clinic of Ondokuz Mayıs University Faculty of Medicine. The control group comprises physically and psychologically healthy children and adolescents who presented to the Faculty of Dentistry of Ondokuz Mayıs University. Participants in both groups will be selected within the age range of 12-18 years. All participating children, adolescents, and their legal guardians will be informed both verbally and in writing about the aim of the study, participation criteria, applied procedures, potential benefits, and possible risks. In addition, a questionnaire assessing sociodemographic characteristics, nutrition-related factors, dietary habits, and oral hygiene practices will be completed jointly by the ch | Other | 1. group, 2. group |
Primary outcome
Oral Health-Related Quality of Life (OHRQoL)
Time frame: Through study completion, an average of 1 month.
The primary outcome measure of this study is the assessment of oral health-related quality of life in children and adolescents with eating disorders compared with healthy controls. Oral health-related quality of life will be evaluated using the Oral Health Impact Profile-14 (OHIP-14) questionnaire, and group comparisons will be performed based on total OHIP-14 scores. Higher OHIP-14 scores indicate increased severity of oral health problems and poorer quality of life.
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 27 Oct 2026.
- Results publication1) Mitchell JE. Medical comorbidity and medical complications associated with binge-eating disorder. Int J Eat Disord. 2016;49(3):319-23. 2) Castillo M, Weiselberg E. Bulimia nervosa/purging disorder. Curr Probl Pediatr Adolesc Health Care. 2017 Apr;47(4):85-94. 3) Galmiche M, Déchelotte P, Lambert G, Tavolacci MP. Prevalence of eating disorders over the 2000-2018 period: a systematic literature review. Am J Clin Nutr. 2019 May;109(5):1402-13. 4) Garbin CAS, Martins RJ, Belila NM, Garbin AJI. Oral manifestations in patients with anorexia and bulimia nervosa: a systematic review. J Public Health. 2019;28:765-71. 5) Andrade R, Gonçalves-Pinho M, Roma-Torres A, Brandão I. Treatment of anorexia nervosa: the importance of disease progression in the prognosis. Acta Med Portuguesa. (2017) 30:517-23. doi: 10.20344/amp.8963 6) Resmark G, Herpertz S, Herpertz-Dahlmann B, Zeeck A. Treatment of anorexia nervosa-new evidence-based guidelines. J Clin Med. (2019) 8:153. doi: 10.3390/jcm8020153 7) Naito M, Yuasa H, Nomura Y, Nakayama T, Hamajima N, Hanada N. Oral health status and health-related quality of life: a systematic review. J Oral Sci. 2006;48(1):1-7. 8) Kragt L, van der Tas JT, Moll HA, et al. Early caries predicts low oral health-related quality of life at a later age. Caries Res. 2016;50(5):471-479. 9) Chaffee BW, Rodrigues PH, Kramer PF, Vitolo MR, Feldens CA. Oral health-related quality-of-life scores differ by socioeconomic status and caries experience. Community Dent Oral Epidemiol. 2017;45(3):216-224 10) Allen PF (2003). Sep 08. Assessment of oral health related quality of life. Health Qual Life Outcomes 1: 40 11) Hellstrom, I. (1977). Oral complications in anorexia nervosa. Scand J Dent Res. 8: 71-76 12) Hurst, P.S., LACEY, L.H., CRİSP, A.H. (1977). Teeth, vomiting and diet: a study of the dental characteristics of seventeen anorexia nervosa patients. Postgrad Med J., 53: 298-305. 13) Bartlett D, Ganss C, Lussi A. Basic Erosive Wear Examination (BEWE): a new scori
- Individual participant dataSharing planned: No
Related trials for Eating Disorder NOS
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder
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.
elif buse k kaplan, research assistant principal investigator
Ondokuz Mayıs Üniversity
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 Eating Disorder NOS, run by Ondokuz Mayıs 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 14 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 27 Oct 2026. 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?
Oral Health-Related Quality of Life (OHRQoL) (time frame: Through study completion, an average of 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07896707, which also lists 1 linked publication.
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 27 Oct 2026.