Oral Indicators for ED Screening
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorUniversity of Bologna
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
461 Participants
are grouped into 1 trial groupGroup A: Observational Cohort
Trial outcomes
Primary outcomes
1
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)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).
Time frame
Baseline (single assessment)Sponsors and contacts
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Source ClinicalTrials.gov