Oral Indicators for ED Screening

NCT07295197 | Recruiting

• 1 other identifier: OHEDS
• Study Type: observational
• Target: 461
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

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.

  Baseline (single assessment during routine dental visit)

Secondary Outcomes (1)

• Sensitivity, specificity, PPV, NPV and ICC of the OHEDs Checklist

  Baseline (single assessment)

Study Arms (1)

Observational Cohort

This is an observational study. No interventions are administered and all assessments are part of routine clinical care.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Clinica Odontoiatrica - Reparto di Igiene Dentale, Università di Bologna

Bologna, 40125, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 38915100 RESULT

Related Links

• Italian National Platform for Eating Disorders (ISS)

MeSH Terms

Conditions

Feeding and Eating Disorders; Tooth Erosion

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Central Study Contacts

Marco Montevecchi

CONTACT

0039‭0512088128‬; m.montevecchi@unibo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: November 14, 2025
• Primary Completion: April 14, 2026
• Study Completion: April 14, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available when the research will be published
• Access Criteria: On request to the main investigator

Locations

IT (1)