ObesityNCT00531154
Evaluation of the Dental Health Condition in Obesity Patients Before and After Bariatric Surgery
An observational study of Obesity and Periodontitis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The aim of this study is to investigate whether there was an association between obesity and periodontitis, tendency to caries and periapical lesions. People who have a higher body mass index produce cytokines (hormone-like proteins), that lead to systemic/chronic inflammation (like periodontitis and periapical… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Periodontitis, Caries
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese pateints who intended to go bariatric surgery.
Who cannot join
- Coronary heart disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
The aim of this study is to investigate whether there was an association between obesity and periodontitis, tendency to caries and periapical lesions.
People who have a higher body mass index produce cytokines (hormone-like proteins), that lead to systemic/chronic inflammation (like periodontitis and periapical lesions), and obesity related dietary habits could result in an increment of dental caries because both the amount and the frequency of sucrose ingestion are important factors associated with the aetiology of the oral disease.
- Conditions
- Obesity, Periodontitis, Caries, Periapical Lesion
- Medical subject headings
- Obesity, Periodontitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Ilana Heling, Prof., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531154
- Sponsor's protocol ID
- heling-HMO-CTIL
- Status last verified
- Sep 2007
- First submitted
- 17 Sep 2007
- Last updated
- 18 Sep 2007
- Results posted
- No
Publications
Pischon N, Heng N, Bernimoulin JP, Kleber BM, Willich SN, Pischon T. Obesity, inflammation, and periodontal disease. J Dent Res. 2007 May;86(5):400-9. doi: 10.1177/154405910708600503.
PubMed 17452558Linden G, Patterson C, Evans A, Kee F. Obesity and periodontitis in 60-70-year-old men. J Clin Periodontol. 2007 Jun;34(6):461-6. doi: 10.1111/j.1600-051X.2007.01075.x. Epub 2007 Apr 2.
PubMed 17403015Karjalainen S. Eating patterns, diet and dental caries. Dent Update. 2007 Jun;34(5):295-8, 300. doi: 10.12968/denu.2007.34.5.295.
PubMed 17624146Heling I, Sgan-Cohen HD, Itzhaki M, Beglaibter N, Avrutis O, Gimmon Z. Dental complications following gastric restrictive bariatric surgery. Obes Surg. 2006 Sep;16(9):1131-4. doi: 10.1381/096089206778392211.
PubMed 16989694
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dental Health Condition in Obesity Patients Before and After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00531154
- Acronym / sponsor ID
- heling-HMO-CTIL
- Conditions
- Obesity, Periodontitis, Caries, Periapical Lesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 18 Sep 2007 (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.
The aim of this study is to investigate whether there was an association between obesity and periodontitis, tendency to caries and periapical lesions.
People who have a higher body mass index produce cytokines (hormone-like proteins), that lead to systemic/chronic inflammation (like periodontitis and periapical lesions), and obesity related dietary habits could result in an increment of dental caries because both the amount and the frequency of sucrose ingestion are important factors associated with the aetiology of the oral disease.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese pateints who intended to go bariatric surgery.
Key exclusion criteria (1 listed)
- Coronary heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2007.
- Background: PubMed 17452558Pischon N, Heng N, Bernimoulin JP, Kleber BM, Willich SN, Pischon T. Obesity, inflammation, and periodontal disease. J Dent Res. 2007 May;86(5):400-9. doi: 10.1177/154405910708600503.
- Background: PubMed 17403015Linden G, Patterson C, Evans A, Kee F. Obesity and periodontitis in 60-70-year-old men. J Clin Periodontol. 2007 Jun;34(6):461-6. doi: 10.1111/j.1600-051X.2007.01075.x. Epub 2007 Apr 2.
- Background: PubMed 17624146Karjalainen S. Eating patterns, diet and dental caries. Dent Update. 2007 Jun;34(5):295-8, 300. doi: 10.12968/denu.2007.34.5.295.
- Results publication: PubMed 16989694Heling I, Sgan-Cohen HD, Itzhaki M, Beglaibter N, Avrutis O, Gimmon Z. Dental complications following gastric restrictive bariatric surgery. Obes Surg. 2006 Sep;16(9):1131-4. doi: 10.1381/096089206778392211.
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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.
Ilana Heling, Prof. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Periodontitis, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 1 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 18 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 Ilana Heling, Prof. (0097226778344, heling@cc.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00531154, which also lists 4 linked publications.
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 18 Sep 2007.