ClinicalTrials.gg
RecruitingNCT05809778Updated May 16, 2025

Oral Lesions in Patients With Eating Disorders

An observational study in Eating Disorders, sponsored by IRCCS Burlo Garofolo. Recruiting at 1 site in Italy. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by IRCCS Burlo Garofolo · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2021; still recruiting 5 years 3 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
81
Ages
10 Years to 18 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Eating Disorders

Keywords

  • Eating disorders
  • Pral lesions
  • Prevention
  • Prevalence
03

In context

Feeding and Eating Disorders

645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.

This study's planned enrollment of 81 is below the median of 102 across 177 observational studies indexed under Feeding and Eating Disorders.

Browse Feeding and Eating Disorders studies →

Lead sponsor

IRCCS Burlo Garofolo is the lead sponsor of 89 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients affected by eating disorders

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnosis of ED
  2. Age between 10 and 18 years

Exclusion criteria

Exclusion Criteria:

  1. Parents or caregivers not understanding the Italian language
  2. Patients affected by other systemic diseases
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
81 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prevalence of oral lesions in ED affected patients

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

    Time frame: At baseline (day 1)

Secondary outcomes

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

    Clinical data will be collected by clinical records

    Time frame: At baseline (day 1)

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

    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.

    Time frame: At baseline (day 1)

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

    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.

    Time frame: At baseline (day 1)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2021 (actual). Primary completion is estimated for Dec 2025, 53 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2023
First posted
Apr 12, 2023
StartActual
Jul 21, 2021
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
May 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05809778
Lead sponsor
IRCCS Burlo Garofolo
Responsible party
Sponsor
First posted
Apr 12, 2023
Start date
Jul 21, 2021
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 16, 2025

Study contacts

Milena Cadenaro, MD
Contact
milena.cadenaro@burlo.trieste.it
+390403785393
Valentina Luppieri, MD
Contact
valentina.luppieri@burlo.trieste.it
00390403785393
Milena Cadenaro, MD
study director · Institute for Maternal and Child Health IRCCS Burlo Garofolo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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