Clinical trial NCT05809778: Oral Lesions in Patients With Eating Disorders
Official title: Oral Lesions in Patients Dealing With Eating Disorders: an Epidemiological Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eating Disorders
Keywords: Eating disorders
Pral lesions
Prevention
Prevalence
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 81
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by eating disorders

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of oral lesions in ED affected patients
timeFrame: At baseline (day 1)
Secondary outcomes:
measure: To evaluate the association between presence of oral lesions and type of ED
timeFrame: At baseline (day 1)
measure: To evaluate the association between presence of oral lesions and patients' global functioning index
timeFrame: At baseline (day 1)
measure: To evaluate the association between presence of oral lesions and patients' self-perception about oral health
timeFrame: At baseline (day 1)
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Study officials:
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofolo
name: Milena Cadenaro, MD
role: STUDY_DIRECTOR
References: