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

May 1, 2017 updated by: Hélène Rangé, University Paris 7 - Denis Diderot
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75012
        • Recruiting
        • Rothschild Hospital
        • Contact:
      • Villejuif, France, 94800
        • Recruiting
        • Paul Brousse Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at examination day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gingival inflammation
Time Frame: at examination day
Gingival inflammation is measured by bleeding on probing score (%) at 6 sites per tooth.
at examination day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Paris 7 - Denis Diderot

Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Chair: Philippe Bouchard, DDS, PhD, Paris Diderot University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13588

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD will be available on request.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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