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NCT Number: NCT05809778

Oral Lesions in Patients With Eating Disorders

Eating disorders (ED) are common among young. Anorexia (AN) and bulimia (BN) are the most prevalent ED. The American Psychiatric Association's guidelines state a 0.3% AN prevalence among young girls and a 0.1 to 4.2% BN prevalence. Men are not excluded: even if ED are more frequent in females (14-18 years), 1 man off to 10 can be diagnosed with ED. Unfortunately, the onset age is decreasing. In the last few years, always more preteens patients are diagnosed with ED: they generally refer a garbled self perception of body image. ED can have oral manifestations, such as: mucosal lesions, dental erosion, glandular hypertrophy, xerostomia and salivary disorders, dental caries These are the most common manifestations observed in patients with eating disorders, after a routine dental visit. There is not strong evidence that dental caries may be directly related to disordered eating habits; as a matter of fact results are controversial. Despite that, all the studies examined agree on the association between signs listed above and food disorders. Univocal percentages have not been reported in the scientific literature. For instance, a systematic review, dated 2016, showed that dental erosion is diagnosed in 45% of ED people, while other studies documented 70% patients affected by erosion. Another example reported is teeth hypersensitivity. According to some studies, 56% of ED patients reported such complaints, instead of other researches documenting 22% hypersensitivity impairment. As for dental caries, results are dissimilar. Authors showed 78% ED subjects diagnosed with dental caries. Other studies reported almost 50% patients with tooth decay, without statistically significant difference in the values between ED people and controls. All these differences are probably due to the different stages of eating disorders and diagnosis, and oral signs found. Different ages are also considered. The primary aim of the study is to evaluate the prevalence of oral cavity lesions among people affected by eating disorders.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

Location status: Recruiting

Location contact

Valentina Luppieri, MD

CONTACT

[email protected]

+390403785393

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of ED
  • Age between 10 and 18 years

Exclusion criteria

  • Parents or caregivers not understanding the Italian language
  • Patients affected by other systemic diseases

Treatment and study plan

Primary outcomes

  1. Prevalence of oral lesions in ED affected patients

    Time frame: At baseline (day 1)

    Mucosal lesions, dental erosion, glandular hypertrophy, xerostomia or other salivary disorders, and dental caries will be examined.

Secondary outcomes

  1. To evaluate the association between presence of oral lesions and type of ED

    Time frame: At baseline (day 1)

    Clinical data will be collected by clinical records

  2. To evaluate the association between presence of oral lesions and patients' global functioning index

    Time frame: At baseline (day 1)

    Patients' global functioning index will be defined by the Global Assessment of Functioning (GAF), an integral part of the standard multiaxial psychiatric diagnostic system. The purpose of including the GAF in DSM-IV as a tool for axis V assessment is to enable clinicians to obtain information about global functioning to supplement existing data about symptoms and diagnoses and to help predict the allocation and outcomes of mental health treatment. The GAF provides a score from 1 to 100: 1 for situation with low functioning; 100 for situation of complete wellbeing.

  3. To evaluate the association between presence of oral lesions and patients' self-perception about oral health

    Time frame: At baseline (day 1)

    Patients' self-perception about oral health will be defined by the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ), evaluating the oral health-related quality of life: 23 items, with a five-point likert scale ranging from 1 to 5 (1 = strongly disagree and 5 = strongly agree), analyzing dental self-confidence, social impact, psychological impact and aesthetic concern. The Italian version was validated in 2014. The possible range of summary scores varied between 0 to 92. Higher scores indicate a greater degree of negative psychosocial impact.

Study contacts

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

Milena Cadenaro, MD

CONTACT

[email protected]

+390403785393

Valentina Luppieri, MD

CONTACT

[email protected]

00390403785393

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

Oral Lesions in Patients Dealing With Eating Disorders: an Epidemiological Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 12, 2023
Registry last updated
May 16, 2025

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

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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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