Periodontal Impact of Eating Disorders (the PERIOED Study)

Periodontal Diseases Clinical Trial

— PERIOED  

Official title:

Periodontal Impact of Eating Disorders (the PERIOED Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02960152
• Other study ID #: 13588
• Status: Recruiting
• Phase: N/A
• First received: November 7, 2016
• Last updated: May 1, 2017
• Start date: October 2014
• Est. completion date: January 2018

Study information

• Verified date: May 2017
• Source: University Paris 7 - Denis Diderot
• Contact: Hélène Rangé, DDS, PhD
• Phone: 33 6 23 98 02 59
• Email: helene.range[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluated the periodontal status of patients suffering from eating disorders (anorexia nervosa and bulimia nervosa). The work hypothesis is that eating disorder patients have a higher risk for periodontal diseases than non-eating disorder subjects.

Description:

Eating disorders have been associated with poor oral health. However, the relationship between eating disorders and periodontal diseases is less-established. Participants will be periodontally assessed using a full-mouth clinical evaluation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• In and out eating disorder patients

• Subject with a diagnosis of anorexia nervosa or bulimia nervosa for at least 5 years

• Subject affiliated to the French social insurance

Exclusion Criteria:

• Subject who do not speak French

• Subject who is not able to read and/or understand the information form

• Subject who take anti-inflammatory medications or antibiotics at dental examination

• Subject who has received any dental treatment that could interfere with the periodontal status 3 month before the clinical examination (scaling and root planning, orthodontic treatment ongoing)

• Subject who has less than 10 teeth

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Bulimia
• Bulimia Nervosa
• Disease
• Eating Disorder
• Feeding and Eating Disorders
• Gingival Diseases
• Periodontal Diseases

Intervention

Other:
• diagnostic
full-mouth periodontal examination

Locations

Country	Name	City	State
France	Rothschild Hospital	Paris
France	Paul Brousse Hospital	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
University Paris 7 - Denis Diderot	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Attachment Loss (CAL)	Periodontal probing depth and gingival recession are measured in millimeters using a manual periodontal probe (HuFriedy PCP UNC 15 probe, Chicago, IL, USA). At the clinical examination day, CAL is calculated as periodontal probing depth (mm) + gingival recession (mm) at 6 sites per tooth.	at examination day
Secondary	gingival inflammation	Gingival inflammation is measured by bleeding on probing score (%) at 6 sites per tooth.	at examination day