Periodontal DiseasesPERIOEDNCT02960152
Periodontal Impact of Eating Disorders (the PERIOED Study)
An observational study of Periodontal Diseases and Eating Disorder, run by University Paris 7 - Denis Diderot at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Eating Disorder, Anorexia Nervosa
- What is being tested?
- diagnostic
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2014to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients suffering from eating disorders referred to the Psychiatric and Addiction department at the Paul Brousse Hospital (Villejuif, France)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Rothschild Hospital
Paris, 75012
Hélène Rangé, DDS, PhD, 33 6 23 98 02 59, helene.range@gmail.com
- Recruiting
Paul Brousse Hospital
Villejuif, 94800
Damien Ringuenet, MD, 33 1 45 59 33 71, damien.ringuenet@aphp.fr
About this study
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.
Read the 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.
- Being tested
- diagnostic
- Keywords
- periodontitis
- Medical subject headings
- Periodontal Diseases, Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosticOther
full-mouth periodontal examination
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa | interview and periodontal full-mouth examination Receives: Other: diagnostic | |
| Bulimia Nervosa | interview and periodontal full-mouth examination Receives: Other: diagnostic | |
| Control | interview and periodontal full-mouth examination Receives: Other: diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at examination day
Secondary outcomes (1)
gingival inflammation
Gingival inflammation is measured by bleeding on probing score (%) at 6 sites per tooth.
Measured: at examination day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startOct 2014
- Primary completionSep 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Paris 7 - Denis Diderot
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Principal investigator, Hélène Rangé, University Paris 7 - Denis Diderot
- Investigators
- Philippe Bouchard, DDS, PhD, Study chair, Paris Diderot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960152
- Sponsor's protocol ID
- 13588
- Acronym
- PERIOED
- Status last verified
- May 2017
- First submitted
- 7 Nov 2016
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: IPD will be available on request.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Impact of Eating Disorders (the PERIOED Study)
- ClinicalTrials.gov ID
- NCT02960152
- Acronym / sponsor ID
- PERIOED / 13588
- Keywords
- periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Paris 7 - Denis DiderotUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- Oct 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa | – | Other: diagnosticinterview and periodontal full-mouth examination |
| Bulimia Nervosa | – | Other: diagnosticinterview and periodontal full-mouth examination |
| Control | – | Other: diagnosticinterview and periodontal full-mouth examination |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients suffering from eating disorders referred to the Psychiatric and Addiction department at the Paul Brousse Hospital (Villejuif, France)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosticfull-mouth periodontal examination | Other | Anorexia Nervosa, Bulimia Nervosa, Control |
Primary outcome
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.
1 secondary outcome
gingival inflammation
Time frame: at examination day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Individual participant dataSharing planned: Yes. IPD will be available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Bouchard, DDS, PhD study chair
Paris Diderot University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Eating Disorder, run by University Paris 7 - Denis Diderot at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hélène Rangé, DDS, PhD (33 6 23 98 02 59, helene.range@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Loss (CAL) (time frame: at examination day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.