Condition category
Mental and Behavioural Disorders
Date applied
06/11/2016
Date assigned
16/11/2016
Last edited
16/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

http://www.aphp.fr

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

Publication citations

Additional files

Editorial Notes