Class II Div 1 MalocclusionRCTNCT04202016
The Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design
A study testing Piezocision Surgery in people with Class II Div 1 Malocclusion, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
23 female participants with class II div I will have extraction of bilateral first bicuspids 10 weeks after bond- up appointment. The extracted teeth will be preserved in special containers for subsequent microscopic analysis. Read more about this study
- Who is it for?
- Ages 15 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Class II Div 1 Malocclusion
- What is being tested?
- Piezocision Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteJordan
- Study dates
- 1 Nov 2018to 30 Dec 2020
- 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 15 to 29 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Young adults and adults (15-29).
- Middleastern Caucasian.
- Females.
- Having the defined orthodontic appliance, slot size, prescription, and technique of space closure.
- Class II division I of moderate space requirement that is planned to have the first premolar extracted.
- Average or high facial type.
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- Healthy patients without systematic diseases that could affect bone and tooth movement and no contraindication (medical or psychological) to avoid oral surgery.
- No active periodontal diseases as this effect the cytokines expression (stabilized prostaglandin (PG) health)
- Good oral hygiene.
- No other method of non-surgical acceleration technique to be used.
Who cannot join
- Patients who refused to consent for the study.
- The two extremes of age (younger than 14 and older than 29).
- Having other than the defined orthodontic appliance, slot size, prescription, and technique of space closure.
- Extraction cases of high space requirements or other teeth than the first premolar.
- Patients with systematic diseases that could affect bone and tooth movement and no contraindication (medical or psychological) avoid oral surgery.
- Active periodontal diseases.
- Other methods of non-surgical acceleration technique to be used.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Postgraduate orthodontic clinics, Jordan University of Science and Technology
Irbid, 21110
About this study
Official title: Three Dimensional Analysis of the Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design Randomized Controlled Trial
23 female participants with class II div I will have extraction of bilateral first bicuspids 10 weeks after bond- up appointment. The extracted teeth will be preserved in special containers for subsequent microscopic analysis. Four months later, upon space closure phase, the patient will have a piezocision surgery on one side randomly chosen. Virtual models will be generated once before the surgery and monthly after for four and a half months. The models will be scanned by CADCAM and later tooth movement will be analyzed in regards to the rugae area.
- Conditions
- Class II Div 1 Malocclusion
- Being tested
- Piezocision Surgery
- Keywords
- Canine retraction, Space closure, Rate of tooth movement, Facial divergence, Piezocision
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezocision SurgeryProcedure or surgery
After a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made.
| Study group | Role | What they receive |
|---|---|---|
| Piezocision on high facial divergence | Experimental | Piezocision Surgery prior to space closure with closing coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. Receives: Procedure: Piezocision Surgery |
| High facial divergence | No intervention | Space closure with coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. |
| Piezocision on average facial divergence | Experimental | Piezocision Surgery prior to space closure with closing coil spring four months after extraction. Six weeks later, three follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. Receives: Procedure: Piezocision Surgery |
| Average facial divergence | No intervention | Space closure with coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of space closure
Every six weeks from the first impression, made on the day of surgery (T0), an impression will be taken, (T1, T2, T3). Images of the impressions will be generated using computer-aided design and computer-aided manufacturing (CADCAM) to evaluate the space changes from a fixed reference point; the rugae area.
Measured: four and half months
Secondary outcomes (1)
Root resorption
The extraction will take place 10 weeks after the bonding up-appointment. Atraumatic extraction of the upper first premolars will be executed. The periodontist, performing the extraction, will have the extracted teeth stored in containers that contain sterilized deionized water.
Each tooth will be placed in ultrasonic bath for 10 minutes to loosen any residual periodontal ligament's and soft tissue fragments' traces which will be later removed by wet gauze with a rubbing motion. Each tooth will be scanned three dimensionally by a desktop X-ray micro-tomography system. Teeth will be scanned with X-rays while being rotated over 360°. Three-dimension object will be generated by a 3D cone beam reconstruction algorithm utilizing the 2D images that have resulted from the scanning process.
Measured: Ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Nov 2018
- Primary completion30 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Div 1 MalocclusionStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design will be a split-mouth where the participants should need extraction based treatment in collateral sides of the upper arch with one of the sides serving as the treatment while the other will be the control. Then they will be grouped based on their facial type.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, University of Sydney
- Responsible party
- Principal investigator, Hadeel alaathal, Jordan University of Science and Technology
- Investigators
- Kazem S. Alnimri, Professor, Study director, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202016
- Sponsor's protocol ID
- 20190232
- Acronym
- RCT
- Status last verified
- Feb 2021
- First submitted
- 14 Dec 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Analysis of the Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04202016
- Acronym / sponsor ID
- RCT / 20190232
- Conditions
- Class II Div 1 Malocclusion
- Keywords
- Canine retraction, Space closure, Rate of tooth movement, Facial divergence, Piezocision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Edinburgh, University of Sydney
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 17 Dec 2019 (actual)
- 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.
23 female participants with class II div I will have extraction of bilateral first bicuspids 10 weeks after bond- up appointment. The extracted teeth will be preserved in special containers for subsequent microscopic analysis. Four months later, upon space closure phase, the patient will have a piezocision surgery on one side randomly chosen. Virtual models will be generated once before the surgery and monthly after for four and a half months. The models will be scanned by CADCAM and later tooth movement will be analyzed in regards to the rugae area.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The design will be a split-mouth where the participants should need extraction based treatment in collateral sides of the upper arch with one of the sides serving as the treatment while the other will be the control. Then they will be grouped based on their facial type.
| Arm | Type | Receives |
|---|---|---|
| Piezocision on high facial divergence | Experimental | Procedure: Piezocision SurgeryPiezocision Surgery prior to space closure with closing coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. |
| High facial divergence | No intervention | –Space closure with coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. |
| Piezocision on average facial divergence | Experimental | Procedure: Piezocision SurgeryPiezocision Surgery prior to space closure with closing coil spring four months after extraction. Six weeks later, three follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. |
| Average facial divergence | No intervention | –Space closure with coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Young adults and adults (15-29).
- Middleastern Caucasian.
- Females.
- Having the defined orthodontic appliance, slot size, prescription, and technique of space closure.
- Class II division I of moderate space requirement that is planned to have the first premolar extracted.
Key exclusion criteria (7 listed)
- Patients who refused to consent for the study.
- The two extremes of age (younger than 14 and older than 29).
- Having other than the defined orthodontic appliance, slot size, prescription, and technique of space closure.
- Extraction cases of high space requirements or other teeth than the first premolar.
- Patients with systematic diseases that could affect bone and tooth movement and no contraindication (medical or psychological) avoid oral surgery.
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 |
|---|---|---|
| Piezocision SurgeryAfter a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made. | Procedure or surgery | Piezocision on average facial divergence, Piezocision on high facial divergence |
Primary outcome
Rate of space closure
Time frame: four and half months
Every six weeks from the first impression, made on the day of surgery (T0), an impression will be taken, (T1, T2, T3). Images of the impressions will be generated using computer-aided design and computer-aided manufacturing (CADCAM) to evaluate the space changes from a fixed reference point; the rugae area.
1 secondary outcome
Root resorption
Time frame: Ten weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Kazem S. Alnimri, Professor study director
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezocision Surgery in people with Class II Div 1 Malocclusion, run by Jordan University of Science and Technology at 1 site in Jordan.
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 10 inclusion and 7 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: finished, as of the sponsor's last update on 16 Feb 2021. 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of space closure (time frame: four and half months). 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 Feb 2021.