Eating DisordersNCT05809778
Oral Lesions in Patients With Eating Disorders
An observational study of Eating Disorders, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Eating Disorders
- How many people
- 81 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jul 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients affected by eating disorders
Who may be able to join
- Diagnosis of ED
- Age between 10 and 18 years
Who cannot join
- Parents or caregivers not understanding the Italian language
- Patients affected by other systemic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, Trieste, 34137
Valentina Luppieri, MD, +390403785393, valentina.luppieri@burlo.trieste.it
About this study
Official title: 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.
- Conditions
- Eating Disorders
- Keywords
- Eating disorders, Pral lesions, Prevention, Prevalence
- Medical subject headings
- Feeding and Eating Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (day 1)
Secondary outcomes (3)
To evaluate the association between presence of oral lesions and type of ED
Clinical data will be collected by clinical records
Measured: At baseline (day 1)
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.
Measured: At baseline (day 1)
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.
Measured: At baseline (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start21 Jul 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milena Cadenaro, MD, Study director, Institute for Maternal and Child Health IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809778
- Sponsor's protocol ID
- RC 18/21
- Status last verified
- May 2025
- First submitted
- 29 Mar 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Lesions in Patients Dealing With Eating Disorders: an Epidemiological Study
- ClinicalTrials.gov ID
- NCT05809778
- Acronym / sponsor ID
- RC 18/21
- Conditions
- Eating Disorders
- Keywords
- Eating disorders, Pral lesions, Prevention, Prevalence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients affected by eating disorders
Key inclusion criteria (2 listed)
- Diagnosis of ED
- Age between 10 and 18 years
Key exclusion criteria (2 listed)
- Parents or caregivers not understanding the Italian language
- Patients affected by other systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Milena Cadenaro, MD study director
Institute for Maternal and Child Health IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milena Cadenaro, MD (+390403785393, milena.cadenaro@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of oral lesions in ED affected patients (time frame: At baseline (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.