Periodontal DiseaseNCT02010307
Polymorphonuclear Cells' Sensitivity to Aggregatibacter Actinomycetemcomitans Bacteria in Patients With Aggressive Periodontitis
A study testing blood extraction in people with Periodontal Disease, run by Polak David at 1 site in Israel.
Trial summary
aggressive periodontitis is an inflammatory disease which damage the teeth supporting structures mostly in young patients. and has genetic basis. a specific bacteria: Aggregatibacter actinomycetemcomitans (Aa) is associated with this disease, and found to damage leukocytes by using a specific leukotoxin. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- blood extraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Oct 2015
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients in periodontal department
- healthy
- diagnosed with chronic/aggressive periodontal disease
- interested in participating the research
Who cannot join
- diagnosed with diabetes, heart disease, immunosuppression, thrombocytopenia, clotting enzyme deficiency.
- using alcohol, or drugs
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
aggressive periodontitis is an inflammatory disease which damage the teeth supporting structures mostly in young patients. and has genetic basis.
a specific bacteria: Aggregatibacter actinomycetemcomitans (Aa) is associated with this disease, and found to damage leukocytes by using a specific leukotoxin.
in the research the investigators are aiming to find molecular and immunological basis to aggressive periodontitis.
- Conditions
- Periodontal Disease
- Being tested
- blood extraction
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood extractionOther
6 ml blood extraction from each patients in all 3 arms of the study
| Study group | Role | What they receive |
|---|---|---|
| aggressive periodontitis | Experimental | 25 patients with aggressive periodontitis blood extraction Receives: Other: blood extraction |
| chronic periodontitis | Experimental | 25 patients with chronic periodontitis blood extraction Receives: Other: blood extraction |
| healthy | Experimental | 25 healthy periodontal patients blood extraction Receives: Other: blood extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
flow cytometry
the investigators use flow cytometry technique in order to determine the influence of gingival bacteria on the leukocytes, after culturing the two together.
Measured: 12 hours after blood extraction
Secondary outcomes (1)
microscopy observation
the investigators use microscopy in order to determine the influence of gingival bacteria on the leukocytes, after culturing the two together
Measured: 12 hours after blood extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polak David
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Polak David, Hadassah Medical Organization
- Investigators
- David Polak, DMD, PhD, Principal investigator, Haddasah Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010307
- Sponsor's protocol ID
- davidp-HMO-CTIL
- Status last verified
- Dec 2013
- First submitted
- 9 Dec 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphonuclear Cells' Sensitivity to Aggregatibacter Actinomycetemcomitans Bacteria in Patients With Aggressive Periodontitis
- ClinicalTrials.gov ID
- NCT02010307
- Acronym / sponsor ID
- davidp-HMO-CTIL
- Conditions
- Periodontal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Polak DavidUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 12 Dec 2013 (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.
aggressive periodontitis is an inflammatory disease which damage the teeth supporting structures mostly in young patients. and has genetic basis.
a specific bacteria: Aggregatibacter actinomycetemcomitans (Aa) is associated with this disease, and found to damage leukocytes by using a specific leukotoxin.
in the research the investigators are aiming to find molecular and immunological basis to aggressive periodontitis.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aggressive periodontitis | Experimental | Other: blood extraction25 patients with aggressive periodontitis blood extraction |
| chronic periodontitis | Experimental | Other: blood extraction25 patients with chronic periodontitis blood extraction |
| healthy | Experimental | Other: blood extraction25 healthy periodontal patients blood extraction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients in periodontal department
- healthy
- diagnosed with chronic/aggressive periodontal disease
- interested in participating the research
Key exclusion criteria (3 listed)
- diagnosed with diabetes, heart disease, immunosuppression, thrombocytopenia, clotting enzyme deficiency.
- using alcohol, or drugs
- pregnancy
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 |
|---|---|---|
| blood extraction6 ml blood extraction from each patients in all 3 arms of the study | Other | aggressive periodontitis, chronic periodontitis, healthy |
Primary outcome
flow cytometry
Time frame: 12 hours after blood extraction
the investigators use flow cytometry technique in order to determine the influence of gingival bacteria on the leukocytes, after culturing the two together.
1 secondary outcome
microscopy observation
Time frame: 12 hours after blood extraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
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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.
David Polak, DMD, PhD principal investigator
Haddasah Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood extraction in people with Periodontal Disease, run by Polak David 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 4 inclusion and 3 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 16 Dec 2013. 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 David Polak, DMD, PhD (00972- 52-593-3961, polak@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flow cytometry (time frame: 12 hours after blood extraction). 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 16 Dec 2013.