Plain English Summary
Background and study aims:
Eating disorders are serious mental health conditions where the sufferer has an unhealthy relationship with food. The most common forms of eating disorders are anorexia nervosa, where the sufferer tries to keep their body weight as low as possible usually by severely restricts the amount they eat and exercising excessively, and bulimia nervosa, where the sufferer tries to control their weight by severely restricting the amount of food they eat, then binge eating and purging the food from their body by making themselves vomit or using laxatives. Nowadays, unknowns exist regarding the role of malnutrition (lack of proper nutrition) in the causes and management of periodontitis (gum disease). Therefore, there is an urgent need of studies exploring the relationship between eating disorders and periodontal conditions. The aim of this study is to determine the link between gum disease and eating disorders.
Who can participate?
Adult women with anorexia nervosa or bulimia nervosa and healthy women of the same age.
What does the study involve?
Participants in all groups attend a single study visit. At the visit, participants are interviewed about their oral hygeine behaviours, whether they smoke and how long they have had an eating disorder for (if from the anorexic or bulemic group). They then receive a full mouth examination to check for missing teeth and to assess gum health. At the end of the study, the results from the three patient groups are compared.
What are the possible benefits and risks of participating?
Participants benefit from receiving a specialized full-mouth examination, a gum disease assessment and dental advice. There are no notable risks involved with participating in this study.
Where is the study run from?
1. Paul Brousse Hospital (France)
2. Rothschild Hospital (France)
When is study starting and how long is it expected to run for?
January 2014 to January 2018
Who is funding the study?
Assistance Publique Hôpitaux de Paris (France)
Who is the main contact?
1. Dr Hélène Rangé (public)
helene.range@aphp.fr
2. Professor Philippe Bouchard (scientific)
philippe.bouchard@aphp.fr
Trial website
Contact information
Type
Public
Primary contact
Dr Hélène Rangé
ORCID ID
Contact details
Department of Periodontology
Service of Odontology
Rothschild Hospital
AP-HP
5 rue Santerre
Paris
75012
France
+33 6 1465 6947
helene.range@aphp.fr
Type
Scientific
Additional contact
Prof Philippe Bouchard
ORCID ID
Contact details
Department of Periodontology
Service of Odontology
Rothschild Hospital
AP-HP
5 rue Santerre
Paris
75012
France
+33 6 1465 6947
philippe.bouchard@aphp.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CPP n°13588
Study information
Scientific title
Periodontal Impact of Eating Disorders: the PERIOED case-control study
Acronym
PERIOED
Study hypothesis
Eating disorder patients have a higher risk for periodontal inflammation than non-eating disorder subjects.
Ethics approval
Ethical Research Comittee CPP Ile de France I, 08/09/2014, ref: IRB 00008522
Study design
Observational cross-sectional case-control single-centre study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
1. Anorexia nervosa
2. Bulimia nervosa
Intervention
All participants attend one single visit at baseline.
Firstly, this visit involves a patient interview in order to record the oral hygiene behaviors (dental visits frequency and toothbrushing habits), addictions (tobacco smoking status) and characteristics associated with eating disorders (duration in months, restricted eating profile and self-induced vomiting profile). Secondly, participants receive a full-mouth periodontal examination, at 6 sites per tooth (except third molars), using a manual periodontal probe (HuFriedy PCP UNC 15 probe, Chicago, IL, USA). The number of missing teeth is reported. Dental plaque index and bleeding on probing score are recorded using a dichotomic approach. Periodontal probing depths and gingival recession are measured in millimeters using the periodontal probe.
Intervention type
Phase
Drug names
Primary outcome measures
Clinical Attachment Level (CAL) is calculated as follows: periodontal probing depth (in mm) added to gingival recession height (in mm), which are measured with a manual periodontal probe (6 sites per tooth) at the day of the oral examination.
Secondary outcome measures
Gingival inflammation is measured using the bleeding on probing score (% of sites) at the day of the oral examination.
Overall trial start date
01/01/2014
Overall trial end date
01/01/2018
Reason abandoned
Eligibility
Participant inclusion criteria
Anorexia nervosa participants:
1. Age 18 to 65 years old
2. Female
3. A proper diagnosis of anorexia nervosa for at least 5 years
4. Affiliated to the French social insurance
Bulimia nervosa participants:
1. Age 18 to 65 years old
2. Female
3. A proper diagnosis of bulimia nervosa for at least 5 years
4. Affiliated to the French social insurance
Non-eating disorder participants:
1. Age 18 to 65 years old
2. Female
3. Non-eating disorder volunteer
4. Affiliated to the French social insurance
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
The target number of participants was 90, with 30 anorexia nervosa inpatients, 30 bulimia nervosa inpatients and 30 controls.
Participant exclusion criteria
1. Unable to speak French
2. Unable to read and/or understand the information form
3. Taking anti-inflammatory medications or antibiotics at dental examination
4. Previously received any dental treatment that could interfere with the periodontal status 3 months before the clinical examination (scaling and root planning, orthodontic treatment ongoing)
5. Having less than 10 teeth
Recruitment start date
07/10/2014
Recruitment end date
07/11/2016
Locations
Countries of recruitment
France
Trial participating centre
Psychiatric and Addiction Department, Paul Brousse Hospital, AP-HP
12 avenue Paul Vaillant Couturier
Villejuif
94800
France
Trial participating centre
Department of Periodontology, Service of Odontology, Rothschild Hospital, AP-HP
5 rue Santerre
Paris
75012
France
Sponsor information
Organisation
Assistance Publique Hôpitaux de Paris (APHP)
Sponsor details
3 Avenue Victoria
Paris
75004
France
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Assistance Publique - Hôpitaux de Paris
Alternative name(s)
Assistance Publique Hôpitaux de Paris, AP-HP
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
France
Results and Publications
Publication and dissemination plan
Publish in an international journal on nutrition in 2017 (first semester)
IPD Sharing plan:
Requests for data should be sent to the corresponding authors Hélène Rangé (helene.jan@aphp.fr ) or Philippe Bouchard (philippe.bouchard@aphp.fr)
Intention to publish date
01/01/2017
Participant level data
Available on request
Results - basic reporting
Publication summary