Oral Lesions in Patients With Eating Disorders

Eating Disorders Clinical Trial

Official title:

Oral Lesions in Patients Dealing With Eating Disorders: an Epidemiological Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809778
• Other study ID #: RC 18/21
• Status: Recruiting
• Start date: July 21, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: IRCCS Burlo Garofolo
• Contact: Milena Cadenaro, MD
• Phone: +390403785393
• Email: milena.cadenaro[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating Disorders
• Feeding and Eating Disorders

Locations

Country	Name	City	State
Italy	Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the association between presence of oral lesions and type of ED	Clinical data will be collected by clinical records	At baseline (day 1)
Secondary	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.	At baseline (day 1)
Secondary	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.	At baseline (day 1)