- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05809778
Oral Lesions in Patients With Eating Disorders
May 13, 2025 updated by: IRCCS Burlo Garofolo
Oral Lesions in Patients Dealing With Eating Disorders: an Epidemiological Study
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
81
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Milena Cadenaro, MD
- Phone Number: +390403785393
- Email: milena.cadenaro@burlo.trieste.it
Study Contact Backup
- Name: Valentina Luppieri, MD
- Phone Number: 00390403785393
- Email: valentina.luppieri@burlo.trieste.it
Study Locations
-
-
-
Trieste, Italy, 34137
- Recruiting
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
-
Contact:
- Valentina Luppieri, MD
- Phone Number: +390403785393
- Email: valentina.luppieri@burlo.trieste.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients affected by eating disorders
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline (day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
At baseline (day 1)
|
|
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.
|
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)
|
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.
|
At baseline (day 1)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Milena Cadenaro, MD, Institute for Maternal and Child Health IRCCS Burlo Garofolo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 21, 2021
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
March 29, 2023
First Submitted That Met QC Criteria
April 11, 2023
First Posted (Actual)
April 12, 2023
Study Record Updates
Last Update Posted (Actual)
May 16, 2025
Last Update Submitted That Met QC Criteria
May 13, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC 18/21
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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