Aggressive PeriodontitisNCT01510808
The Affect of Orthodontic Treatment on the Periodontal Status of Patients With Aggressive Periodontitis
An observational study of Aggressive Periodontitis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Orthodontic Treatment will affect the periodontal status of periodontally treated Aggressive Periodontitis patients. Read more about this study
- Who is it for?
- Ages 13 to 40 years
- Conditions the study is for
- Aggressive Periodontitis
- What is being tested?
- orthodontic treatment
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to 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 13 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients with aggressive periodontitis in maintenance that had completed orthodontic treatment
Who may be able to join
- patients with aggressive periodontitis in maintenance that had completed orthodontic treatment
- age 13-40
- with full records of periodontal treatment
- with full records of orthodontic treatment
Who cannot join
- smoking over 10 cigarets/day
- non controlled diabetes
- pregnancy
- alcohol consumption
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of periodontology - Hadassah hospital
Jerusalem
Tali Chackartchi, Dr, +972-54-2345055, tali222@hotmail.com
Tali Chackartchi, DMD
About this study
Orthodontic Treatment will affect the periodontal status of periodontally treated Aggressive Periodontitis patients.
- Conditions
- Aggressive Periodontitis
- Being tested
- orthodontic treatment
- Keywords
- aggressive periodontitis orthodontic stability
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthodontic treatmentProcedure or surgery
Patients with Aggressive Periodontitis which are in the maintenance phase, had been treated for malocclusion.
| Study group | Role | What they receive |
|---|---|---|
| aggressive Periodontitis | Aggressive Periodontitis during maintenance Receives: Procedure: orthodontic treatment | |
| aggressive periodontitis | aggressive periodontitis patients during maintenance Receives: Procedure: orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
periodontal pocket depth
Measured: one year
Secondary outcomes (1)
PAR index
index for measuring the stability of orthodontic treatment results.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aggressive PeriodontitisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tali Chackartchi, Hadassah Medical Organization
- Investigators
- Tali Chackartchi, DMD, Study director, Hadassa Medical Organization - department of periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510808
- Sponsor's protocol ID
- 0173-11-HMO-CTIL
- Status last verified
- Jan 2012
- First submitted
- 11 Jan 2012
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Passanezi E, Janson M, Janson G, Sant'Anna AP, de Freitas MR, Henriques JF. Interdisciplinary treatment of localized juvenile periodontitis: a new perspective to an old problem. Am J Orthod Dentofacial Orthop. 2007 Feb;131(2):268-76. doi: 10.1016/j.ajodo.2005.03.025.
PubMed 17276870
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affect of Orthodontic Treatment on the Periodontal Status of Patients With Aggressive Periodontitis
- ClinicalTrials.gov ID
- NCT01510808
- Acronym / sponsor ID
- 0173-11-HMO-CTIL
- Conditions
- Aggressive Periodontitis
- Keywords
- aggressive periodontitis orthodontic stability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2012
- First posted
- 18 Jan 2012 (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.
Orthodontic Treatment will affect the periodontal status of periodontally treated Aggressive Periodontitis patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aggressive Periodontitis | – | Procedure: orthodontic treatmentAggressive Periodontitis during maintenance |
| aggressive periodontitis | – | Procedure: orthodontic treatmentaggressive periodontitis patients during maintenance |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients with aggressive periodontitis in maintenance that had completed orthodontic treatment
Key inclusion criteria (4 listed)
- patients with aggressive periodontitis in maintenance that had completed orthodontic treatment
- age 13-40
- with full records of periodontal treatment
- with full records of orthodontic treatment
Key exclusion criteria (4 listed)
- smoking over 10 cigarets/day
- non controlled diabetes
- pregnancy
- alcohol consumption
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 |
|---|---|---|
| orthodontic treatmentPatients with Aggressive Periodontitis which are in the maintenance phase, had been treated for malocclusion. | Procedure or surgery | aggressive Periodontitis, aggressive periodontitis |
Primary outcome
periodontal pocket depth
Time frame: one year
1 secondary outcome
PAR index
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
- Background: PubMed 17276870Passanezi E, Janson M, Janson G, Sant'Anna AP, de Freitas MR, Henriques JF. Interdisciplinary treatment of localized juvenile periodontitis: a new perspective to an old problem. Am J Orthod Dentofacial Orthop. 2007 Feb;131(2):268-76. doi: 10.1016/j.ajodo.2005.03.025.
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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.
Tali Chackartchi, DMD study director
Hadassa Medical Organization - department of periodontology
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 Aggressive 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 4 inclusion and 4 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 Jan 2012. 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 Arik Tzukert, DMD (00 972 2 6776095, arik@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periodontal pocket depth (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01510808, which also lists 1 linked publication.
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 Jan 2012.