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Periodontal Impact of Eating Disorders (the PERIOED Study) (PERIOED)

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ClinicalTrials.gov Identifier: NCT02960152
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Hélène Rangé, University Paris 7 - Denis Diderot

Brief 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.

Condition or disease Intervention/treatment
Periodontal Diseases Eating Disorder Anorexia Nervosa Bulimia Nervosa Other: diagnostic

Detailed 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.

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Periodontal Impact of Eating Disorders (the PERIOED Study)
Study Start Date : October 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Group/Cohort Intervention/treatment
Anorexia Nervosa
interview and periodontal full-mouth examination
Other: diagnostic
full-mouth periodontal examination

Bulimia Nervosa
interview and periodontal full-mouth examination
Other: diagnostic
full-mouth periodontal examination

Control
interview and periodontal full-mouth examination
Other: diagnostic
full-mouth periodontal examination




Primary Outcome Measures :
  1. Clinical Attachment Loss (CAL) [ Time Frame: at examination day ]
    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.


Secondary Outcome Measures :
  1. gingival inflammation [ Time Frame: at examination day ]
    Gingival inflammation is measured by bleeding on probing score (%) at 6 sites per tooth.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients suffering from eating disorders referred to the Psychiatric and Addiction department at the Paul Brousse Hospital (Villejuif, France)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960152


Contacts
Contact: Hélène Rangé, DDS, PhD 33 6 23 98 02 59 helene.range@gmail.com

Locations
France
Rothschild Hospital Recruiting
Paris, France, 75012
Contact: Hélène Rangé, DDS, PhD    33 6 23 98 02 59    helene.range@gmail.com   
Paul Brousse Hospital Recruiting
Villejuif, France, 94800
Contact: Damien Ringuenet, MD    33 1 45 59 33 71    damien.ringuenet@aphp.fr   
Sponsors and Collaborators
University Paris 7 - Denis Diderot
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Philippe Bouchard, DDS, PhD Paris Diderot University

Responsible Party: Hélène Rangé, Dr, University Paris 7 - Denis Diderot
ClinicalTrials.gov Identifier: NCT02960152     History of Changes
Other Study ID Numbers: 13588
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be available on request.

Keywords provided by Hélène Rangé, University Paris 7 - Denis Diderot:
periodontitis

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Periodontal Diseases
Gingival Diseases
Mental Disorders
Mouth Diseases
Stomatognathic Diseases
Anorexia
Anorexia Nervosa
Bulimia
Bulimia Nervosa
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Hyperphagia