NCT05809778

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

4.4 years

First QC Date

March 29, 2023

Last Update Submit

May 13, 2025

Conditions

Keywords

Eating disordersPral lesionsPreventionPrevalence

Outcome Measures

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.

    At baseline (day 1)

Secondary Outcomes (3)

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

    At baseline (day 1)

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

    At baseline (day 1)

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

    At baseline (day 1)

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients affected by eating disorders

You may qualify if:

  • Diagnosis of ED
  • Age between 10 and 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Trieste, Trieste, 34137, Italy

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Milena Cadenaro, MD

    Institute for Maternal and Child Health IRCCS Burlo Garofolo

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 12, 2023

Study Start

July 21, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations