Acceleration of Tooth MovementNCT03782766
Mandibular Second Molar Protraction Assisted by Piezocision
A study testing Piezocision in people with Acceleration of Tooth Movement and Piezocision, run by Jordan University of Science and Technology.
Trial summary
This study was conducted to compare the rate of second molar protraction, level of Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque index, and periodontal pocket depth) and perception of pain in patients treated by molar protraction with piezocision vs control (no piezocision). Read more about this study
- Who is it for?
- Ages 20 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Acceleration of Tooth Movement, Piezocision
- What is being tested?
- Piezocision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2015to 4 Oct 2018
- 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 20 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age range from 20 to 27 years
- at least one extracted mandibular first molar (first molar extracted more than one year ago and residual extraction space more than 5 mm)
- Class 1 malocclusion where molar protraction is indicated
- all permanent teeth are present except for the extracted mandibular first molar/molars.
Who cannot join
- Ggingival index score > 2
- Plaque index score > 2
- Probing depth > 4mm
- Previous orthodontic treatment
- Systemic disease and
- Smoker.
About this study
Official title: Mandibular Second Molar Protraction Assisted by and Piezocision
This study was conducted to compare the rate of second molar protraction, level of Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque index, and periodontal pocket depth) and perception of pain in patients treated by molar protraction with piezocision vs control (no piezocision).
Read the detailed description
Twenty-six subjects (39 Molars) who presented with at least one extracted mandibular first molar were selected to participate in the study. The subjects were subdivided into one of 3 groups as follows: group 1 consisted of 18 molars (13 molars from patients with bilateral first molar extraction space and 5 molars from patients with unilateral first molar extraction space) where piezocision was performed immediately before molar protraction; group 2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8 molars from patients with unilateral first molar extraction space) where molar protraction was performed with no piezocision; group 3 consisted of 21 molars (group 2 subjects where piezocision was carried on after 3 months of molar protraction with no piezocision. After reaching 0.019X0.025" SS arch wire, NiTi coil spring was used for space closure (protraction force was 150g) attached from the lower second molar hook to the head of the mini-screw. Piezocision was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.
Gingival crevicular fluid (GCF) sample was obtained from the mesiogingival side of the lower second permanent molar with use of Periopaper. GCF sample was repeated 1 day, 1 week and 4 weeks after molar protraction with piezocision or with no piezocision. Pain was assessed using visual analog scale (VAS). Patients were requested to report the level of pain for 7 consecutive days.
- Conditions
- Acceleration of Tooth Movement, Piezocision
- Being tested
- Piezocision
- Keywords
- Piezocision, Temporary anchorage device, molar protraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezocisionProcedure or surgery
Piezocesion was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.
| Study group | Role | What they receive |
|---|---|---|
| piezosurgery | Experimental | group 1 consisted of 18 molars (13 molars from patients with bilateral first molar extraction space and 5 molars from patients with unilateral first molar extraction space) where piezocesion was performed immediately before molar protraction Receives: Procedure: Piezocision |
| No piezocision | No intervention | group 2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8 molars from patients with unilateral first molar extraction space) where molar protraction was performed with no piezocesion |
| Late piezocision | Other | group 3 consisted of 21 molars (group 2 subjects where piezocession was carried on after 3 months of molar protraction with no piezocesion. Receives: Procedure: Piezocision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of second molar protraction
measured in mm/month from onscreen dental cast
Measured: up to 3 months
Changes in the level of of Interleukin1-β
detected in Gingival crevicular fluid (GCF)
Measured: Immediately before protraction/piezocision, 1 day, 1 week and 4 weeks after protraction/piezocision
Secondary outcomes (2)
Anchorage loss
Distal movement of second premolar in mm per month
Measured: Each month up to 3 months
Pain Perception: Visual analogue scale (VAS)
Assessed using visual analog scale (VAS) where 0 = no pain and 10 = worst pain. The participants filled out questionnaire to assess the pain intensity and interference after second molar protraction with or without piezocision on 1, 2, 3, 4, 5, 6 and 7 days of intervention.
Measured: Every day up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start2 Sep 2015
- Primary completion4 Oct 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceleration of Tooth MovementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three models:- * Split mouth design where piezocision will be performed on the right of left side of the patient in bilateral first molar extraction space subjects. * comparison between 2 groups of subjects; one group where protraction is done with piezocision and the other group where protraction was done with no piezocision. * third part where the same side of space receives the 2 interventions. Molar protraction started with no piezocision for 3 months followed by piezocision and protraction for another 3 months,
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Abu Alhaija, Jordan University of Science and Technology
- Investigators
- Elham S A Alhaija, Principal investigator, Prof.- Main thesis supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782766
- Sponsor's protocol ID
- 416/2016
- Status last verified
- Dec 2018
- First submitted
- 15 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Second Molar Protraction Assisted by and Piezocision
- ClinicalTrials.gov ID
- NCT03782766
- Acronym / sponsor ID
- 416/2016
- Conditions
- Acceleration of Tooth Movement, Piezocision
- Keywords
- Piezocision, Temporary anchorage device, molar protraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 2 Sep 2015 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 20 Dec 2018 (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.
This study was conducted to compare the rate of second molar protraction, level of Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque index, and periodontal pocket depth) and perception of pain in patients treated by molar protraction with piezocision vs control (no piezocision).
Detailed description
Twenty-six subjects (39 Molars) who presented with at least one extracted mandibular first molar were selected to participate in the study. The subjects were subdivided into one of 3 groups as follows: group 1 consisted of 18 molars (13 molars from patients with bilateral first molar extraction space and 5 molars from patients with unilateral first molar extraction space) where piezocision was performed immediately before molar protraction; group 2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8 molars from patients with unilateral first molar extraction space) where molar protraction was performed with no piezocision; group 3 consisted of 21 molars (group 2 subjects where piezocision was carried on after 3 months of molar protraction with no piezocision. After reaching 0.019X0.025" SS arch wire, NiTi coil spring was used for space closure (protraction force was 150g) attached from the lower second molar hook to the head of the mini-screw. Piezocision was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.
Gingival crevicular fluid (GCF) sample was obtained from the mesiogingival side of the lower second permanent molar with use of Periopaper. GCF sample was repeated 1 day, 1 week and 4 weeks after molar protraction with piezocision or with no piezocision. Pain was assessed using visual analog scale (VAS). Patients were requested to report the level of pain for 7 consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
- Model description
- Three models:- * Split mouth design where piezocision will be performed on the right of left side of the patient in bilateral first molar extraction space subjects. * comparison between 2 groups of subjects; one group where protraction is done with piezocision and the other group where protraction was done with no piezocision. * third part where the same side of space receives the 2 interventions. Molar protraction started with no piezocision for 3 months followed by piezocision and protraction for another 3 months,
| Arm | Type | Receives |
|---|---|---|
| piezosurgery | Experimental | Procedure: Piezocisiongroup 1 consisted of 18 molars (13 molars from patients with bilateral first molar extraction space and 5 molars from patients with unilateral first molar extraction space) where piezocesion was performed immediately before molar protraction |
| No piezocision | No intervention | –group 2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8 molars from patients with unilateral first molar extraction space) where molar protraction was performed with no piezocesion |
| Late piezocision | Other | Procedure: Piezocisiongroup 3 consisted of 21 molars (group 2 subjects where piezocession was carried on after 3 months of molar protraction with no piezocesion. |
Who may qualify
- Ages
- 20 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age range from 20 to 27 years
- at least one extracted mandibular first molar (first molar extracted more than one year ago and residual extraction space more than 5 mm)
- Class 1 malocclusion where molar protraction is indicated
- all permanent teeth are present except for the extracted mandibular first molar/molars.
Key exclusion criteria (6 listed)
- Ggingival index score > 2
- Plaque index score > 2
- Probing depth > 4mm
- Previous orthodontic treatment
- Systemic disease and
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 |
|---|---|---|
| PiezocisionPiezocesion was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm. | Procedure or surgery | Late piezocision, piezosurgery |
Primary outcome
Rate of second molar protraction
Time frame: up to 3 months
measured in mm/month from onscreen dental cast
Changes in the level of of Interleukin1-β
Time frame: Immediately before protraction/piezocision, 1 day, 1 week and 4 weeks after protraction/piezocision
detected in Gingival crevicular fluid (GCF)
2 secondary outcomes
Anchorage loss
Time frame: Each month up to 3 months
Pain Perception: Visual analogue scale (VAS)
Time frame: Every day up to 7 days
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 20 Dec 2018.
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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.
Elham S A Alhaija principal investigator
Prof.- Main thesis supervisor
Questions about this trial
What is this clinical trial studying?
A study testing Piezocision in people with Acceleration of Tooth Movement and Piezocision, run by Jordan University of Science and Technology.
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 6 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 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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 second molar protraction (time frame: up to 3 months). The study lists 2 primary outcomes in all. 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 20 Dec 2018.