PiezocorticisionNCT03308851
Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction
A study testing Piezocorticision and Osteoperforation in people with Piezocorticision and Osteoperforation, run by Université de Montréal at 1 site in Canada.
Trial summary
The primary objective of this research is to compare the rate of canine retraction following the osteoperforation and piezocorticision procedures in cases of first premolar extractions. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Piezocorticision, Osteoperforation, Canine Retraction
- What is being tested?
- Piezocorticision and Osteoperforation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 30 Apr 2021
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Dental and/or skeletal Cl I and II requiring maxillary first premolar extraction.
- Young adults 16 years and older.
- Good overall health.
- Complete adult dentition.
- Cooperative.
- Acceptable hygiene.
- Absence of any periodontal disease (gingivitis, periodontitis).
Who cannot join
- Non-cooperative, fearful patients or patients with intellectual disability.
- Patients requiring the regular use of nonsteroidal anti-inflammatory drugs (NSAID).
- Use of antibiotics in the last 6 months.
- Previous or current use of bisphosphonates, corticosteroids or immunosuppressive drugs.
- Smokers.
- Patients suffering from uncontrolled systemic diseases (ex. diabetes type I and II).
- Presence of oral or maxillofacial malformations (ex. cleft palate) or dental pathologies (ex. ankylosis, abscess).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinique d'orthodontie de l'Université de Montréal
Montreal, Quebec, H3V1H9
About this study
Official title: Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction: Randomized Controlled Clinical Trial.
The primary objective of this research is to compare the rate of canine retraction following the osteoperforation and piezocorticision procedures in cases of first premolar extractions. The secondary objectives are to compare the second order movement of the canine (tipping), the amount of root resorption associated with the procedures, the inflammation process by measuring the inflammatory markers in the gingival crevicular fluid, the loss of posterior anchorage by measures on the cone beam computed tomography (CBCT) 3-dimensional radiograph and on the casts and to evaluate the pain level and the impact on quality of life following each procedure using the questionnaire of the visual analogue scale (VAS) of pain.
- Being tested
- Piezocorticision, Osteoperforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezocorticisionProcedure or surgery
The piezocorticision is a procedure that aims to accelerate the movement of teeth during an orthodontic treatment. It consists of a local anaesthesia followed by an incision of the buccal mucosa and an incision in the alveolar bone with a piezotome.
OsteoperforationProcedure or surgery
The osteoperforation is a procedure that aims to accelerate the movement of teeth during orthodontic treatment. It consists of a local anaesthesia followed by perforations of the buccal mucosa and alveolar bone using a specific osteoperforation tool.
| Study group | Role | What they receive |
|---|---|---|
| Piezocorticision and osteoperforation group | Experimental | All participants in this arm will receive the piezocorticision and osteoperforation procedures on the upper jaw on the left and the right side. Receives: Procedure: Piezocorticision; Procedure: Osteoperforation |
| Control | No intervention | The participants in this arm will receive no treatment, but will have the same monitoring as the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of canine retraction
The speed at which the canine is moved in the space of the extracted premolar.
Measured: From the time of force application until the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks. Measures will be taken at two week intervals.
Secondary outcomes (7)
Amount of tipping
The angulation of the long axis of the canine at the end of the retraction.
Measured: The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks
Amount of root resorption
The total reduction in volume of the root of the canine caused by the canine retraction measured on the cone beam computed tomography.
Measured: The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks
Amount of posterior loss of anchorage
Measure of the amount of anterior movement of the posterior teeth during the retraction of the canine.
Measured: The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks
Concentration of IL-1 in the gingival fluid sample
Measure of the concentration of IL-I using the Luminex technique.
Measured: Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.
Concentration of receptor activator of nuclear factor kappa-B ligand (RANKL) in the gingival fluid sample
Measure of the concentration of RANKL using the Luminex technique.
Measured: Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.
Concentration of osteoprotegerin (OPG) in the gingival fluid sample
Measure of the concentration of OPG using the Luminex technique.
Measured: Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.
Level of pain
Measure of the level of pain using a visual analogue scale of pain questionnaire ranging from 0-10.
Measured: Daily, for 7 days following extraction of premolars and piezocorticision and osteoperforation procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start1 Jan 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Why it stopped: Due to difficulties related to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PiezocorticisionStudies 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
- Crossover
- Model description
- A split mouth design will be used where the experimental subjects will receive one procedure on one side of the upper dental arch and another procedure on the other side.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Le George Dinh-Khang, Université de Montréal
- Investigators
- Clarice Nishio, D.M.D, MSc, PhD, Study director, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308851
- Sponsor's protocol ID
- Piezo and Osteoperforation
- Status last verified
- Jun 2021
- First submitted
- 2 Oct 2017
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction: Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03308851
- Acronym / sponsor ID
- Piezo and Osteoperforation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulties related to COVID
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 13 Oct 2017 (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.
The primary objective of this research is to compare the rate of canine retraction following the osteoperforation and piezocorticision procedures in cases of first premolar extractions. The secondary objectives are to compare the second order movement of the canine (tipping), the amount of root resorption associated with the procedures, the inflammation process by measuring the inflammatory markers in the gingival crevicular fluid, the loss of posterior anchorage by measures on the cone beam computed tomography (CBCT) 3-dimensional radiograph and on the casts and to evaluate the pain level and the impact on quality of life following each procedure using the questionnaire of the visual analogue scale (VAS) of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A split mouth design will be used where the experimental subjects will receive one procedure on one side of the upper dental arch and another procedure on the other side.
| Arm | Type | Receives |
|---|---|---|
| Piezocorticision and osteoperforation group | Experimental | Procedure: Piezocorticision, Procedure: OsteoperforationAll participants in this arm will receive the piezocorticision and osteoperforation procedures on the upper jaw on the left and the right side. |
| Control | No intervention | –The participants in this arm will receive no treatment, but will have the same monitoring as the experimental group. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Dental and/or skeletal Cl I and II requiring maxillary first premolar extraction.
- Young adults 16 years and older.
- Good overall health.
- Complete adult dentition.
- Cooperative.
Key exclusion criteria (7 listed)
- Non-cooperative, fearful patients or patients with intellectual disability.
- Patients requiring the regular use of nonsteroidal anti-inflammatory drugs (NSAID).
- Use of antibiotics in the last 6 months.
- Previous or current use of bisphosphonates, corticosteroids or immunosuppressive drugs.
- Smokers.
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 |
|---|---|---|
| PiezocorticisionThe piezocorticision is a procedure that aims to accelerate the movement of teeth during an orthodontic treatment. It consists of a local anaesthesia followed by an incision of the buccal mucosa and an incision in the alveolar bone with a piezotome. | Procedure or surgery | Piezocorticision and osteoperforation group |
| OsteoperforationThe osteoperforation is a procedure that aims to accelerate the movement of teeth during orthodontic treatment. It consists of a local anaesthesia followed by perforations of the buccal mucosa and alveolar bone using a specific osteoperforation tool. | Procedure or surgery | Piezocorticision and osteoperforation group |
Primary outcome
Rate of canine retraction
Time frame: From the time of force application until the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks. Measures will be taken at two week intervals.
The speed at which the canine is moved in the space of the extracted premolar.
7 secondary outcomes
Amount of tipping
Time frame: The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks
Amount of root resorption
Time frame: The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks
Amount of posterior loss of anchorage
Time frame: The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks
Concentration of IL-1 in the gingival fluid sample
Time frame: Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.
Concentration of receptor activator of nuclear factor kappa-B ligand (RANKL) in the gingival fluid sample
Time frame: Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.
Concentration of osteoprotegerin (OPG) in the gingival fluid sample
Time frame: Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.
Level of pain
Time frame: Daily, for 7 days following extraction of premolars and piezocorticision and osteoperforation procedures
Results and safety
The study was stopped early (reason given: Due to difficulties related to COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: Undecided
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.
Clarice Nishio, D.M.D, MSc, PhD study director
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezocorticision and Osteoperforation in people with Piezocorticision and Osteoperforation, run by Université de Montréal at 1 site in Canada.
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 7 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: stopped early, as of the sponsor's last update on 10 Jun 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 Canada. 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 was stopped early (reason given: Due to difficulties related to COVID). Results are not available in the source record.
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 canine retraction (time frame: From the time of force application until the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks. Measures will be taken at two week intervals.). 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 10 Jun 2021.