An observational study in Eating Disorders, Oral Health and Eating Disorders Symptoms, sponsored by University of Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by University of Bologna · Observational
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.
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.
645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.
This study's planned enrollment of 461 is above the median of 102 across 177 observational studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is an observational study. No interventions are administered and all assessments are part of routine clinical care.
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.
Time frame: Baseline (single assessment during routine dental visit)
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).
Time frame: Baseline (single assessment)
Plan to share: Yes — Anonymized and aggregated data will be made available upon reasonable request once the study findings have been published.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data will be available when the research will be published
Access criteria: On request to the main investigator
Started Nov 2025 (actual). Primary completion is estimated for Apr 2026, 5 months after the start.
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