NCT02960152

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

2.9 years

First QC Date

November 7, 2016

Last Update Submit

May 1, 2017

Conditions

Keywords

periodontitis

Outcome Measures

Primary Outcomes (1)

  • Clinical Attachment Loss (CAL)

    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 Outcomes (1)

  • gingival inflammation

    at examination day

Study Arms (3)

Anorexia Nervosa

interview and periodontal full-mouth examination

Other: diagnostic

Bulimia Nervosa

interview and periodontal full-mouth examination

Other: diagnostic

Control

interview and periodontal full-mouth examination

Other: diagnostic

Interventions

full-mouth periodontal examination

Anorexia NervosaBulimia NervosaControl

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients suffering from eating disorders referred to the Psychiatric and Addiction department at the Paul Brousse Hospital (Villejuif, France)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rothschild Hospital

Paris, 75012, France

RECRUITING

Paul Brousse Hospital

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Periodontal DiseasesFeeding and Eating DisordersAnorexia NervosaBulimia NervosaPeriodontitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Philippe Bouchard, DDS, PhD

    Paris Diderot University

    STUDY CHAIR

Central Study Contacts

Hélène Rangé, DDS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 9, 2016

Study Start

October 1, 2014

Primary Completion

September 1, 2017

Study Completion

January 1, 2018

Last Updated

May 2, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

IPD will be available on request.

Locations