Eating DisordersOHEDSNCT07295197
Oral Indicators for ED Screening
An observational study of Eating Disorders and Oral Health, run by University of Bologna at 1 site in Italy.
Trial summary
The main objective of this research project is to explore the capability of a standardized, evidence-based study tool (the OHEDs Checklist) in the early identification of oro-dental manifestations potentially indicative of an eating disorder. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Oral Health, Eating Disorders Symptoms
- How many people
- 461 participants
- Where
- 1 siteItaly
- Study dates
- 14 Nov 2025to 14 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Consecutively, all subjects aged 18 to 40 years presenting for routine dental care at the participating centers and meeting the inclusion criteria were enrolled. Eligible participants were required to present at least 20 permanent teeth and provide written informed consent. Subjects with systemic diseases, ongoing orthodontic treatment, recent antibiotic use, pregnancy or breastfeeding, or taking xerogenic or mucosa-altering medications were excluded.
Who may be able to join
- Age between 18 and 40 years
- Presence of at least 20 permanent teeth (third molars excluded)
- Both males and females are eligible
- Ability to provide written informed consent
Who cannot join
- Pregnancy or breastfeeding
- Use of systemic antibiotics within the previous month
- Active orthodontic treatment
- Presence of systemic diseases that may affect oral conditions, including: diabetes, ulcerative colitis, Crohn's disease, Sjögren's syndrome, HIV infection, hematologic diseases, neoplasms
- Mental disorders or neuromotor deficits that may interfere with the oro-dental clinical signs evaluated by the OHEDs Checklist
- Use of xerogenic medications or drugs that may alter salivary flow or oral/perioral mucosal conditions, including: antihypertensives, beta-blockers, non-steroidal anti-inflammatory drugs (NSAIDs), antiparkinson medications, anxiolytics, antidepressants, neuroleptics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinica Odontoiatrica - Reparto di Igiene Dentale, Università di Bologna
Bologna, 40125
Marco Montevecchi, DDS, +39 051 2088128, m.montevecchi@unibo.it
About this study
Official title: Analysis of Oro-Dental Manifestations for the Screening of Eating Disorders.
The main objective of this research project is to explore the capability of a standardized, evidence-based study tool (the OHEDs Checklist) in the early identification of oro-dental manifestations potentially indicative of an eating disorder.
The secondary objective is to evaluate the sensitivity and specificity of the OHEDs Checklist in comparison with validated screening instruments for eating disorders, namely the ESP, SCOFF and DEQ questionnaires.
Read the detailed description
The OHEDS (Oral Health Eating Disorders Screening) study aims to investigate whether specific oro-dental manifestations can be used as early indicators of eating disorders. The project arises from increasing scientific evidence linking various clinical oral signs to disordered eating behaviors, including dental erosion, mucosal alterations, dentin hypersensitivity, changes in salivary flow, and dysfunctional oral hygiene habits. Despite these associations, no structured clinical tool currently exists to interpret such signs as potential early warning indicators.
The OHEDs Checklist was developed from a systematic review of the literature, assigning weighted scores to clinical items based on the consistency and robustness of the available evidence. This study seeks to evaluate the discriminative ability of the Checklist's total score by comparing it with validated screening instruments (SCOFF, ESP, DEQ), with the objective of identifying an optimal cutoff for clinical suspicion.
The study is observational, cross-sectional, and multicentric at a national level. All assessments are performed during routine dental visits already scheduled as part of standard clinical practice, without introducing any experimental interventions. After providing informed consent, participants undergo an intraoral clinical examination conducted by trained clinicians, during which the OHEDs Checklist is completed. Participants also complete validated questionnaires assessing disordered eating behaviors. Demographic, behavioral, and general clinical information is collected according to standard anamnesis procedures.
All data are recorded in pseudonymized form within an electronic Case Report Form (CRF) using the REDCap platform (University of Bologna).
The planned sample size is 461 participants. The first dataset (n = 307) provides adequate precision for estimating the expected prevalence of individuals at risk, while a second independent dataset (n = 154) is used for external validation of the identified cutoff.
- Conditions
- Eating Disorders, Oral Health, Eating Disorders Symptoms
- Keywords
- Eating disorders, Oral health, Dental erosion, Oro-dental manifestations, Disordered eating, Screening tool, SCOFF questionnaire, ESP questionnaire, DEQ questionnaire, OHEDs Checklist, OHEDs
- Medical subject headings
- Feeding and Eating Disorders, Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | This is an observational study. No interventions are administered and all assessments are part of routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of participants classified as "at risk" according to the OHEDs Checklist
Proportion of participants who receive a score indicating possible risk for eating disorders on the OHEDs Checklist during the single study visit. This outcome shows how many individuals in the sample are classified as "at risk" based on their Checklist score.
Measured: Baseline (single assessment during routine dental visit)
Secondary outcomes (1)
Sensitivity, specificity, PPV, NPV and ICC of the OHEDs Checklist
To evaluate the diagnostic performance of the OHEDs Checklist by assessing its sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and intraclass correlation coefficient (ICC) in comparison with validated screening tools for eating disorders (SCOFF and ESP).
Measured: Baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start14 Nov 2025
- Primary completion14 Apr 2026 (estimated)
- Study completion14 Apr 2026 (estimated)
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 DisordersStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 461 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Montevecchi, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295197
- Sponsor's protocol ID
- OHEDS
- Acronym
- OHEDS
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized and aggregated data will be made available upon reasonable request once the study findings have been published.
Publications
Valeriani L, Frigerio F, Piciocchi C, Piana G, Montevecchi M, Donini LM, Mocini E. Oro-dental manifestations of eating disorders: a systematic review. J Eat Disord. 2024 Jun 24;12(1):87. doi: 10.1186/s40337-024-01050-8.
PubMed 38915100
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Oro-Dental Manifestations for the Screening of Eating Disorders.
- ClinicalTrials.gov ID
- NCT07295197
- Acronym / sponsor ID
- OHEDS / OHEDS
- Conditions
- Eating Disorders, Oral Health, Eating Disorders Symptoms
- Keywords
- Eating disorders, Oral health, Dental erosion, Oro-dental manifestations, Disordered eating, Screening tool, SCOFF questionnaire, ESP questionnaire
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 461 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 14 Apr 2026 (estimated)
- Study completion
- 14 Apr 2026 (estimated)
- First posted
- 19 Dec 2025 (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 main objective of this research project is to explore the capability of a standardized, evidence-based study tool (the OHEDs Checklist) in the early identification of oro-dental manifestations potentially indicative of an eating disorder.
The secondary objective is to evaluate the sensitivity and specificity of the OHEDs Checklist in comparison with validated screening instruments for eating disorders, namely the ESP, SCOFF and DEQ questionnaires.
Detailed description
The OHEDS (Oral Health Eating Disorders Screening) study aims to investigate whether specific oro-dental manifestations can be used as early indicators of eating disorders. The project arises from increasing scientific evidence linking various clinical oral signs to disordered eating behaviors, including dental erosion, mucosal alterations, dentin hypersensitivity, changes in salivary flow, and dysfunctional oral hygiene habits. Despite these associations, no structured clinical tool currently exists to interpret such signs as potential early warning indicators.
The OHEDs Checklist was developed from a systematic review of the literature, assigning weighted scores to clinical items based on the consistency and robustness of the available evidence. This study seeks to evaluate the discriminative ability of the Checklist's total score by comparing it with validated screening instruments (SCOFF, ESP, DEQ), with the objective of identifying an optimal cutoff for clinical suspicion.
The study is observational, cross-sectional, and multicentric at a national level. All assessments are performed during routine dental visits already scheduled as part of standard clinical practice, without introducing any experimental interventions. After providing informed consent, participants undergo an intraoral clinical examination conducted by trained clinicians, during which the OHEDs Checklist is completed. Participants also complete validated questionnaires assessing disordered eating behaviors. Demographic, behavioral, and general clinical information is collected according to standard anamnesis procedures.
All data are recorded in pseudonymized form within an electronic Case Report Form (CRF) using the REDCap platform (University of Bologna).
The planned sample size is 461 participants. The first dataset (n = 307) provides adequate precision for estimating the expected prevalence of individuals at risk, while a second independent dataset (n = 154) is used for external validation of the identified cutoff.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | –This is an observational study. No interventions are administered and all assessments are part of routine clinical care. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Consecutively, all subjects aged 18 to 40 years presenting for routine dental care at the participating centers and meeting the inclusion criteria were enrolled. Eligible participants were required to present at least 20 permanent teeth and provide written informed consent. Subjects with systemic diseases, ongoing orthodontic treatment, recent antibiotic use, pregnancy or breastfeeding, or taking xerogenic or mucosa-altering medications were excluded.
Key inclusion criteria (4 listed)
- Age between 18 and 40 years
- Presence of at least 20 permanent teeth (third molars excluded)
- Both males and females are eligible
- Ability to provide written informed consent
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding
- Use of systemic antibiotics within the previous month
- Active orthodontic treatment
- Presence of systemic diseases that may affect oral conditions, including: diabetes, ulcerative colitis, Crohn's disease, Sjögren's syndrome, HIV infection, hematologic diseases, neoplasms
- Mental disorders or neuromotor deficits that may interfere with the oro-dental clinical signs evaluated by the OHEDs Checklist
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
Prevalence of participants classified as "at risk" according to the OHEDs Checklist
Time frame: Baseline (single assessment during routine dental visit)
Proportion of participants who receive a score indicating possible risk for eating disorders on the OHEDs Checklist during the single study visit. This outcome shows how many individuals in the sample are classified as "at risk" based on their Checklist score.
1 secondary outcome
Sensitivity, specificity, PPV, NPV and ICC of the OHEDs Checklist
Time frame: Baseline (single assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 38915100Valeriani L, Frigerio F, Piciocchi C, Piana G, Montevecchi M, Donini LM, Mocini E. Oro-dental manifestations of eating disorders: a systematic review. J Eat Disord. 2024 Jun 24;12(1):87. doi: 10.1186/s40337-024-01050-8.
- Italian National Platform for Eating Disorders (ISS)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized and aggregated data will be made available upon reasonable request once the study findings have been published.
Related trials for Eating Disorders
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Recruiting
Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder Part II
Avoidant/Restrictive Food Intake Disorder (ARFID)
Active, not recruiting
Influence of the Urolithin A on the Population With BMI Higher Than 30 During Restricted Eating.
Obesity & Overweight
Enrolling by invitationObservational study
NutFinForce - Lifestyle Performance Medicine Intervention on Defense Performance in Finland
No Condition
Not yet recruiting
Expand Your Horizon-Spanish
Body Image, Body Image Dissatisfaction
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.
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 Disorders and Oral Health, run by University of Bologna at 1 site in Italy.
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 6 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: looking for participants now, as of the sponsor's last update on 19 Dec 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Montevecchi (00390512088128, m.montevecchi@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of participants classified as "at risk" according to the OHEDs Checklist (time frame: Baseline (single assessment during routine dental visit)). 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 NCT07295197, 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 19 Dec 2025.