Periodontal impact of anorexia nervosa and bulimia nervosa

ISRCTN	ISRCTN77400898
DOI	https://doi.org/10.1186/ISRCTN77400898
Secondary identifying numbers	CPP n°13588

Submission date: 06/11/2016
Registration date: 16/11/2016
Last edited: 07/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Hélène Rangé
Public

Department of Periodontology
Service of Odontology, Rothschild Hospital, AP-HP
5 rue Santerre
Paris
75012
France

Phone	+33 6 1465 6947
Email	helene.range@aphp.fr

Prof Philippe Bouchard
Scientific

Department of Periodontology
Service of Odontology, Rothschild Hospital, AP-HP
5 rue Santerre
Paris
75012
France

Phone	+33 6 1465 6947
Email	philippe.bouchard@aphp.fr

Study information

Study design	Observational cross-sectional case-control single-centre study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Periodontal Impact of Eating Disorders: the PERIOED case-control study
Study acronym	PERIOED
Study objectives	Eating disorder patients have a higher risk for periodontal inflammation than non-eating disorder subjects.
Ethics approval(s)	Ethical Research Comittee CPP Ile de France I, 08/09/2014, ref: IRB 00008522
Health condition(s) or problem(s) studied	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	Other
Primary outcome measure	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 study start date	01/01/2014
Completion date	01/01/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	The target number of participants was 90, with 30 anorexia nervosa inpatients, 30 bulimia nervosa inpatients and 30 controls.
Total final enrolment	140
Key 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
Key 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
Date of first enrolment	07/10/2014
Date of final enrolment	07/11/2016

Locations

Countries of recruitment

France

Study participating centres

Psychiatric and Addiction Department, Paul Brousse Hospital, AP-HP

12 avenue Paul Vaillant Couturier
Villejuif
94800
France

Department of Periodontology, Service of Odontology, Rothschild Hospital, AP-HP

5 rue Santerre
Paris
75012
France

Sponsor information

Assistance Publique Hôpitaux de Paris (APHP)
Hospital/treatment centre

3 Avenue Victoria
Paris
75004
France

Website	http://www.aphp.fr
"ROR"	https://ror.org/00pg5jh14

Funders

Funder type

Hospital/treatment centre

Assistance Publique - Hôpitaux de Paris
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Assistance Publique Hôpitaux de Paris, Assistance Publique–Hôpitaux de Paris, AP-HP
Location: France

Results and Publications

Intention to publish date	01/01/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		16/12/2019	06/10/2022	Yes	No
Results article		12/03/2019	06/10/2022	Yes	No

Editorial Notes

07/10/2022: Total final enrolment added.
06/10/2022: Publication references added.