Periodontal Status of Patients Treated With PAO TecNCT01628575
Periodontally Accelerated Orthodontics - A Novel Technique For a Shortened Orthodontic Treatment With a Stable Result. A Clinical and Computerized Tomography Analysis
An observational study of Periodontal Status of Patients Treated With PAO Tec, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Periodontally accelerated orthodontics, also known as PAO, is a novel technique combining alveolar corticotomy and bone grafting prior to commencing orthodontic treatment. Using this technique orthodontic de-crowding and space closing, can be completed in 60-70% less active orthodontic treatment time. Read more about this study
- Who is it for?
- Ages 13 to 85 years
- Conditions the study is for
- Periodontal Status of Patients Treated With PAO Tec
- What is being tested?
- PAO
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to Apr 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients from the department of orthodontics Hadassah medical center
Who may be able to join
- orthodontic treatment with periodontal surgery
Who cannot join
- smoking alcohol consumption pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of periodontology
Jerusalem
Tali Chackartchi, DMD, +972-54-2345055, tali222@hotmail.com
Tali Chackartchi, DMD
About this study
Periodontally accelerated orthodontics, also known as PAO, is a novel technique combining alveolar corticotomy and bone grafting prior to commencing orthodontic treatment. Using this technique orthodontic de-crowding and space closing, can be completed in 60-70% less active orthodontic treatment time. The addition of particulated bone graft following decortication allows for the widening of the bucco-lingual alveolar bony dimension, thus creating space for the movement of teeth, without the creation of dehiscences, usually a negative sequel of the standard orthodontic treatment.
Aim: To evaluate the use of the PAO technique for the treatment of 20 adult patients 1 year post orthodontic treatment.
Methods: 20 periodontally healthy adult patients requiring orthodontic treatment were admitted in the departments of Periodontics and Orthodontics in Hadassah Medical Center. All patients underwent full orthodontic and periodontal examination upon admission including a pretreatment CBCT scan. Decortication followed by grafting was made after the orthodontic appliances have been placed. The orthodontic appliances were activated immediately after surgery and every 2 weeks. During the 1 year follow up a periodontal and orthodontic clinical evaluation were made, as well as a CBCT scan.
Read the detailed description
20 patients were periodontally and orthodontically examined. including: full chart:ppd, free gin line, bleeding on probing, plaque score, teeth mobility. cephalometric analysis, clinical photographes, full periapical x rays.
perio=ortho treatment plan was scheduled, a periodontal surgery for the decortication of buccal bone and bone grafting was preformed.
at the same day orthodontic appliances were activated. in the follow up exam a full periodontal exam will be made (as at the beginning).
the patient will be referred to CBCT scan. all dicom files will be uploaded to simplant software, and measurements will be made: buccal bone width from crest to apex. distance from CEJ to crest. presence of root dehiscence and fenestrations. root resorption.
clinical measurements:
- recessions
- vas
- Being tested
- PAO
- Keywords
- periodontally accelerated orthodontics PAO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAOProcedure or surgery
all patients underwent periodontal surgery for bone decortication followed by orthodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| PAO | patients undergoing orthodontic treatment with the addition of pretreatment periodontal surgery for bone decortication. Receives: Procedure: PAO |
What is being measured
The primary outcome is the main question the study is designed to answer.
buccal bone width
Measured: 1 year
Secondary outcomes (2)
recessions
location of free gingival margin acording to CEJ
Measured: 1 year
root resorption
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 posted27 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Status of Patients Treated With PAO TecStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 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, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628575
- Sponsor's protocol ID
- HMO-0626-11
- Status last verified
- Jun 2012
- First submitted
- 23 Jun 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontally Accelerated Orthodontics - A Novel Technique For a Shortened Orthodontic Treatment With a Stable Result. A Clinical and Computerized Tomography Analysis
- ClinicalTrials.gov ID
- NCT01628575
- Acronym / sponsor ID
- HMO-0626-11
- Keywords
- periodontally accelerated orthodontics PAO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 27 Jun 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.
Periodontally accelerated orthodontics, also known as PAO, is a novel technique combining alveolar corticotomy and bone grafting prior to commencing orthodontic treatment. Using this technique orthodontic de-crowding and space closing, can be completed in 60-70% less active orthodontic treatment time. The addition of particulated bone graft following decortication allows for the widening of the bucco-lingual alveolar bony dimension, thus creating space for the movement of teeth, without the creation of dehiscences, usually a negative sequel of the standard orthodontic treatment.
Aim: To evaluate the use of the PAO technique for the treatment of 20 adult patients 1 year post orthodontic treatment.
Methods: 20 periodontally healthy adult patients requiring orthodontic treatment were admitted in the departments of Periodontics and Orthodontics in Hadassah Medical Center. All patients underwent full orthodontic and periodontal examination upon admission including a pretreatment CBCT scan. Decortication followed by grafting was made after the orthodontic appliances have been placed. The orthodontic appliances were activated immediately after surgery and every 2 weeks. During the 1 year follow up a periodontal and orthodontic clinical evaluation were made, as well as a CBCT scan.
Detailed description
20 patients were periodontally and orthodontically examined. including: full chart:ppd, free gin line, bleeding on probing, plaque score, teeth mobility. cephalometric analysis, clinical photographes, full periapical x rays.
perio=ortho treatment plan was scheduled, a periodontal surgery for the decortication of buccal bone and bone grafting was preformed.
at the same day orthodontic appliances were activated. in the follow up exam a full periodontal exam will be made (as at the beginning).
the patient will be referred to CBCT scan. all dicom files will be uploaded to simplant software, and measurements will be made: buccal bone width from crest to apex. distance from CEJ to crest. presence of root dehiscence and fenestrations. root resorption.
clinical measurements:
- recessions
- vas
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAO | – | Procedure: PAOpatients undergoing orthodontic treatment with the addition of pretreatment periodontal surgery for bone decortication. |
Who may qualify
- Ages
- 13 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients from the department of orthodontics Hadassah medical center
Key inclusion criteria (1 listed)
- orthodontic treatment with periodontal surgery
Key exclusion criteria (1 listed)
- smoking alcohol consumption 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 |
|---|---|---|
| PAOall patients underwent periodontal surgery for bone decortication followed by orthodontic treatment | Procedure or surgery | PAO |
Primary outcome
buccal bone width
Time frame: 1 year
2 secondary outcomes
recessions
Time frame: 1 year
root resorption
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 27 Jun 2012.
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 principal investigator
Hadassah Medical Organization
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 Periodontal Status of Patients Treated With PAO Tec, 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 27 Jun 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 Tali Chackartchi, DMD (+972-54-2345055, tali222@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
buccal bone width (time frame: 1 year). 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 27 Jun 2012.