Orthodontic Tooth MovementNCT05782088
Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement
A study testing Single Piezocision and Repeated Piezocision in people with Orthodontic Tooth Movement and Canine Retraction, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The primary aim of the study is to evaluate the effect of single and repeated piezocisions on the rate of orthodontic tooth movement. Secondary aims are to evaluate the effect of both protocols on molar anchorage loss, as well as on canine root resorption. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Orthodontic Tooth Movement, Canine Retraction
- What is being tested?
- Single Piezocision and Repeated Piezocision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 15 Jan 2024
- 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Malocclusion that requires at least the extraction of maxillary first premolars, such as Class I bimaxillary protrusion, and Class II division 1 cases.
- Normal shape and structure of the maxillary canines, with no history of root canal treatment
Who cannot join
- Patients who underwent previous orthodontic treatment.
- Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement: a Randomized Controlled Clinical Trial
The primary aim of the study is to evaluate the effect of single and repeated piezocisions on the rate of orthodontic tooth movement. Secondary aims are to evaluate the effect of both protocols on molar anchorage loss, as well as on canine root resorption.
- Conditions
- Orthodontic Tooth Movement, Canine Retraction
- Being tested
- Single Piezocision, Repeated Piezocision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single PiezocisionProcedure or surgery
Piezocision will be performed only once before the onset of canine retraction (T0) on one side of the maxillary arch that will be randomly chosen.
Repeated PiezocisionProcedure or surgery
Piezocision will be repeated three times, on a monthly basis (T0, T1, and T2), over the 12-week study period.
| Study group | Role | What they receive |
|---|---|---|
| Single Piezocision | Experimental | Not described Receives: Procedure: Single Piezocision |
| Repeated Piezocision | Experimental | Not described Receives: Procedure: Repeated Piezocision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of canine retraction
Several landmarks will be identified on the dental arch, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.
Measured: 12 weeks
Measurement of molar anchorage loss
Perpendicular lines will be drawn from the central fossae of both maxillary right and left first molars to the mid-palatal raphe. Consequently, molar anchorage loss will be calculated by measuring the distance between those lines, and the lines representing the third rugae as previously mentioned.
Measured: 12 weeks
Measurement of canine root resorption
Root resorption of the maxillary canines will be evaluated and measured by comparing pre-retraction and post-retraction CBCT scans.
Measured: 12 weeks
Bone Microstructure (Fractal Dimension)
Using the collected CBCT scans, the region of interest will be selected within the maxillary alveolar process, and the fractal dimension analysis will be performed using a special software for the maxillary canines in the experimental and control groups.
Measured: 12 weeks
Alveolar bone density
From the acquired pre- and post-retraction CBCTs, bone density will be measured form a coronal cross-section of the maxillary arch around each canine in the experimental and control groups.
Measured: 12 weeks
Alveolar bone thickness
The buccal bone thickness will also be measured at three points from the buccal bone to the root, at the coronal, mid-root, and apical level for each maxillary canine
Measured: 12 weeks
Alveolar bone volume
From the pre- and post-retraction CBCTs (at T0 and T1), bone volume in areas of the maxillary alveolar process surrounding the canines will be measured using a special software.
Measured: 12 weeks
Maxillary canine tipping
Tipping of the maxillary canine during retraction was evaluated by drawing vertical lines on the palatal surfaces of the lateral incisor and the canine that extend from the middle of the incisal edge of the lateral incisor and the cusp tip of the maxillary canine to the middle of the cervical line of each, thereby dividing each of them into equal halves. The distance between the lateral incisor and the canine was assessed at two points on their clinical crowns: incisal, and cervical, enabling the detection of crown tipping of the canine during retraction if there was a difference in the measurements between the both the assessed levels.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion15 Jan 2024
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 Orthodontic 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Farah Y Eid, PhD, Principal investigator, Alexandria UniversityAhmed R El-Kalza, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782088
- Sponsor's protocol ID
- 200
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eid FY, El-Kalza AR. The effect of single versus multiple piezocisions on the rate of canine retraction: a randomized controlled trial. BMC Oral Health. 2024 Aug 30;24(1):1024. doi: 10.1186/s12903-024-04716-6.
PubMed 39215274
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05782088
- Acronym / sponsor ID
- 200
- Conditions
- Orthodontic Tooth Movement, Canine Retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 23 Mar 2023 (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 aim of the study is to evaluate the effect of single and repeated piezocisions on the rate of orthodontic tooth movement. Secondary aims are to evaluate the effect of both protocols on molar anchorage loss, as well as on canine root resorption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Piezocision | Experimental | Procedure: Single Piezocision |
| Repeated Piezocision | Experimental | Procedure: Repeated Piezocision |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Malocclusion that requires at least the extraction of maxillary first premolars, such as Class I bimaxillary protrusion, and Class II division 1 cases.
- Normal shape and structure of the maxillary canines, with no history of root canal treatment
Key exclusion criteria (2 listed)
- Patients who underwent previous orthodontic treatment.
- Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.
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 |
|---|---|---|
| Single PiezocisionPiezocision will be performed only once before the onset of canine retraction (T0) on one side of the maxillary arch that will be randomly chosen. | Procedure or surgery | Single Piezocision |
| Repeated PiezocisionPiezocision will be repeated three times, on a monthly basis (T0, T1, and T2), over the 12-week study period. | Procedure or surgery | Repeated Piezocision |
Primary outcome
Measurement of canine retraction
Time frame: 12 weeks
Several landmarks will be identified on the dental arch, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.
Measurement of molar anchorage loss
Time frame: 12 weeks
Perpendicular lines will be drawn from the central fossae of both maxillary right and left first molars to the mid-palatal raphe. Consequently, molar anchorage loss will be calculated by measuring the distance between those lines, and the lines representing the third rugae as previously mentioned.
Measurement of canine root resorption
Time frame: 12 weeks
Root resorption of the maxillary canines will be evaluated and measured by comparing pre-retraction and post-retraction CBCT scans.
Bone Microstructure (Fractal Dimension)
Time frame: 12 weeks
Using the collected CBCT scans, the region of interest will be selected within the maxillary alveolar process, and the fractal dimension analysis will be performed using a special software for the maxillary canines in the experimental and control groups.
Alveolar bone density
Time frame: 12 weeks
From the acquired pre- and post-retraction CBCTs, bone density will be measured form a coronal cross-section of the maxillary arch around each canine in the experimental and control groups.
Alveolar bone thickness
Time frame: 12 weeks
The buccal bone thickness will also be measured at three points from the buccal bone to the root, at the coronal, mid-root, and apical level for each maxillary canine
Alveolar bone volume
Time frame: 12 weeks
From the pre- and post-retraction CBCTs (at T0 and T1), bone volume in areas of the maxillary alveolar process surrounding the canines will be measured using a special software.
Maxillary canine tipping
Time frame: 12 weeks
Tipping of the maxillary canine during retraction was evaluated by drawing vertical lines on the palatal surfaces of the lateral incisor and the canine that extend from the middle of the incisal edge of the lateral incisor and the cusp tip of the maxillary canine to the middle of the cervical line of each, thereby dividing each of them into equal halves. The distance between the lateral incisor and the canine was assessed at two points on their clinical crowns: incisal, and cervical, enabling the detection of crown tipping of the canine during retraction if there was a difference in the measurements between the both the assessed levels.
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 26 Mar 2024.
- Derived from this study: PubMed 39215274Eid FY, El-Kalza AR. The effect of single versus multiple piezocisions on the rate of canine retraction: a randomized controlled trial. BMC Oral Health. 2024 Aug 30;24(1):1024. doi: 10.1186/s12903-024-04716-6.
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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.
Farah Y Eid, PhD principal investigator
Alexandria University
Ahmed R El-Kalza, PhD study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Piezocision and Repeated Piezocision in people with Orthodontic Tooth Movement and Canine Retraction, run by Nourhan M.Aly at 1 site in Egypt.
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 2 inclusion and 2 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 26 Mar 2024. 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 Egypt. 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?
Measurement of canine retraction (time frame: 12 weeks). The study lists 8 primary outcomes in all. 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 NCT05782088, 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 26 Mar 2024.