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Recruiting NCT05809778

Oral Lesions in Patients With Eating Disorders

Observational Eating Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Eating Disorders. Basic parameters: 10 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Prevalence of oral lesions in ED affected patients [Time frame: At baseline (day 1)]
Secondary outcome measures (3)
  • To evaluate the association between presence of oral lesions and type of ED [Time frame: At baseline (day 1)]
  • To evaluate the association between presence of oral lesions and patients' global functioning index [Time frame: At baseline (day 1)]
  • To evaluate the association between presence of oral lesions and patients' self-perception about oral health [Time frame: At baseline (day 1)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste

Identifiers

NCT: NCT05809778 · RC 18/21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗