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NCT Number: NCT07295197

Oral Indicators for ED Screening

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Odontoiatrica - Reparto di Igiene Dentale, Università di Bologna

Bologna, 40125, Italy

Location status: Recruiting

Location contact

Marco Montevecchi, DDS

CONTACT

[email protected]

+39 051 2088128

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Sensitivity, specificity, PPV, NPV and ICC of the OHEDs Checklist

    Time frame: Baseline (single assessment)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Montevecchi

CONTACT

[email protected]

0039‭0512088128‬

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

Analysis of Oro-Dental Manifestations for the Screening of Eating Disorders.

Acronym: OHEDS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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