Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
461 participants
OBSERVATIONAL
2025-11-14
2026-04-14
Brief Summary
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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
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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
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Observational Cohort
This is an observational study. No interventions are administered and all assessments are part of routine clinical care.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Presence of at least 20 permanent teeth (third molars excluded)
* Both males and females are eligible
* Ability to provide written informed consent
Exclusion Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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University of Bologna
OTHER
Responsible Party
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Marco Montevecchi
Researcher
Locations
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Clinica Odontoiatrica - Reparto di Igiene Dentale, Università di Bologna
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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Marco Montevecchi, DDS
Role: primary
References
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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.
Related Links
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Italian National Platform for Eating Disorders (ISS)
Other Identifiers
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OHEDS
Identifier Type: -
Identifier Source: org_study_id