Power Arm Canine RetractionNCT06352996
Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm
A study testing Three-Dimensional Assessment of Maxillary Canine Retraction with Power Arm and Three-Dimensional Assessment of Maxillary Canine Retraction without Power Arm in people with Power Arm Canine Retraction, run by Mansoura University at 1 site in Egypt.
Trial summary
Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm. Materials and methods:Twenty patients with age range between 14 to 25 years. Before bonding, a hook will be attached to the canine bracket in one side only. Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Power Arm Canine Retraction
- What is being tested?
- Three-Dimensional Assessment of Maxillary Canine Retraction with Power Arm and Three-Dimensional Assessment of Maxillary Canine Retraction without Power Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jun 2023to 30 Jul 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 14 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Class II div 1 patients with age range between 14 to 25 years
- patients indicated for maxillary first premolar extraction
- increased over jet
- mild or no crowding in maxilla
- no previous orthodontic treatment
- no history of periodontal disease or bone loss
Show all 9Show fewer
- good oral hygiene
- no systemic disease
- absence of canine morphological abnormalities.
Who cannot join
- patients not indicated for maxillary first premolar extraction
- decreased or no over jet
- moderate or severe crowding in maxilla
- previous orthodontic treatment
- history of periodontal disease or bone loss
- bad oral hygiene
- systemic disease
- canine morphological abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm: A Split-Mouth Randomized Controlled Trial
Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.
Materials and methods:Twenty patients with age range between 14 to 25 years. Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment then The first premolars will be extracted and mini-implant will be inserted.
Canine retraction using nickel titanium closed coil spring will start in the same day of upper first premolar extraction.
Read the detailed description
Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.
Participant and eligibility criteria:
Twenty patients will be recruited from the Department of Orthodontics at Mansoura University Pre-treatment records will be taken including: Intraoral and extraoral photographs, panoramic radiographs, cephalometric radiographs, and study models.
Intervention:
Written and informed consents will be taken from the patients. All patients will start the treatment by bonding fixed appliance (preadjusted edgewise, 0.018-in. slot, Roth prescription). Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment will be performed until reaching 0.017×0.025-in. nickel titanium arch wire. After 4 weeks of using the 0.017×0.025 arch wire, canine retraction phase will be initiated on 0.016×0.022 stainless steel arch wire.
After leveling and alignment, mini-implants will be inserted interradicular between the upper second premolar and upper first molar on each side. The mini-implant will be ligated to upper second premolar for indirect anchorage. The first premolars will be extracted at the same day of mini-implant placement.
Canine retraction will start in the same day of upper first premolar extraction. A nickel titanium closed coil spring will be stretched from the mini-implant to the power arm on one side, while direct retraction from the bracket will be used on the contralateral side. The retraction force will be adjusted to 150g using force gauge.
- Conditions
- Power Arm Canine Retraction
- Being tested
- Three-Dimensional Assessment of Maxillary Canine Retraction with Power Arm, Three-Dimensional Assessment of Maxillary Canine Retraction without Power Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Dimensional Assessment of Maxillary Canine Retraction with Power ArmOther
A nickel titanium closed coil spring will be stretched from the mini-implant to the power arm will be used for canine retraction.
Three-Dimensional Assessment of Maxillary Canine Retraction without Power ArmOther
A nickel titanium closed coil spring will be stretched from the mini-implant to the canine bracket will be used for canine retraction.
| Study group | Role | What they receive |
|---|---|---|
| power arm canine retraction | Experimental | Not described Receives: Other: Three-Dimensional Assessment of Maxillary Canine Retraction with Power Arm |
| canine retraction without power arm | Experimental | Not described Receives: Other: Three-Dimensional Assessment of Maxillary Canine Retraction without Power Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canine tipping
Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other.
The change in the mesiodistal crown angulation of the canine will be calculated at each time point.
Measured: 4 months
Canine mobility
The Periotest device will be used to measure the mobility of the canine immediately before retraction and repeated monthly for 4 months.
Measured: 4 months
Implant stability
The Periotest device will be used to measure the stability of the mini-implant immediately before retraction and repeated monthly for 4 months.
Measured: 4 months
Pain assessment
Pain assessment will be recorded by the visual analog scale (VAS) form. The participants will be informed to accomplish a visual analog scale diary containing 4 different times: four hours, 24 hours, 72 hours, and one week, following the beginning of the canine retraction.
The pain level was on the 10-cm (100-mm) visual analog scale forms, with 0 (minimum) denoting no pain, while 100 (maximum) denoting sever pain.
Measured: 1 week
canine rotation
Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other.
The change in rotation of the canine will be calculated at each time point.
Measured: 4 months
canine retraction rate
Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other.
The retraction rate will be analyzed monthly and the total amount of canine retraction rate will be measured from cusp tip of the canine T0 to the same point in T4 for both sides.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start9 Jun 2023
- Primary completion9 Mar 2024
- Study completion30 Jul 2024 (estimated)
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 Power Arm Canine RetractionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anas Kassas, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352996
- Sponsor's protocol ID
- Dentist Anas Kassas
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kassas AN, Kamel AM, Mohammad MH, Fouda MAE, Montasser MA. Three-dimensional assessment of mini-implant supported maxillary canine retraction with and without power arm in class II division 1 patients: A split-mouth randomized trial. Int Orthod. 2025 Dec;23(4):101030. doi: 10.1016/j.ortho.2025.101030. Epub 2025 May 30.
PubMed 40449366
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm: A Split-Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06352996
- Acronym / sponsor ID
- Dentist Anas Kassas
- Conditions
- Power Arm Canine Retraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 9 Mar 2024 (actual)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 8 Apr 2024 (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.
Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.
Materials and methods:Twenty patients with age range between 14 to 25 years. Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment then The first premolars will be extracted and mini-implant will be inserted.
Canine retraction using nickel titanium closed coil spring will start in the same day of upper first premolar extraction.
Detailed description
Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.
Participant and eligibility criteria:
Twenty patients will be recruited from the Department of Orthodontics at Mansoura University Pre-treatment records will be taken including: Intraoral and extraoral photographs, panoramic radiographs, cephalometric radiographs, and study models.
Intervention:
Written and informed consents will be taken from the patients. All patients will start the treatment by bonding fixed appliance (preadjusted edgewise, 0.018-in. slot, Roth prescription). Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment will be performed until reaching 0.017×0.025-in. nickel titanium arch wire. After 4 weeks of using the 0.017×0.025 arch wire, canine retraction phase will be initiated on 0.016×0.022 stainless steel arch wire.
After leveling and alignment, mini-implants will be inserted interradicular between the upper second premolar and upper first molar on each side. The mini-implant will be ligated to upper second premolar for indirect anchorage. The first premolars will be extracted at the same day of mini-implant placement.
Canine retraction will start in the same day of upper first premolar extraction. A nickel titanium closed coil spring will be stretched from the mini-implant to the power arm on one side, while direct retraction from the bracket will be used on the contralateral side. The retraction force will be adjusted to 150g using force gauge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| power arm canine retraction | Experimental | Other: Three-Dimensional Assessment of Maxillary Canine Retraction with Power Arm |
| canine retraction without power arm | Experimental | Other: Three-Dimensional Assessment of Maxillary Canine Retraction without Power Arm |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Class II div 1 patients with age range between 14 to 25 years
- patients indicated for maxillary first premolar extraction
- increased over jet
- mild or no crowding in maxilla
- no previous orthodontic treatment
Key exclusion criteria (8 listed)
- patients not indicated for maxillary first premolar extraction
- decreased or no over jet
- moderate or severe crowding in maxilla
- previous orthodontic treatment
- history of periodontal disease or bone loss
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 |
|---|---|---|
| Three-Dimensional Assessment of Maxillary Canine Retraction with Power ArmA nickel titanium closed coil spring will be stretched from the mini-implant to the power arm will be used for canine retraction. | Other | power arm canine retraction |
| Three-Dimensional Assessment of Maxillary Canine Retraction without Power ArmA nickel titanium closed coil spring will be stretched from the mini-implant to the canine bracket will be used for canine retraction. | Other | canine retraction without power arm |
Primary outcome
Canine tipping
Time frame: 4 months
Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other. The change in the mesiodistal crown angulation of the canine will be calculated at each time point.
Canine mobility
Time frame: 4 months
The Periotest device will be used to measure the mobility of the canine immediately before retraction and repeated monthly for 4 months.
Implant stability
Time frame: 4 months
The Periotest device will be used to measure the stability of the mini-implant immediately before retraction and repeated monthly for 4 months.
Pain assessment
Time frame: 1 week
Pain assessment will be recorded by the visual analog scale (VAS) form. The participants will be informed to accomplish a visual analog scale diary containing 4 different times: four hours, 24 hours, 72 hours, and one week, following the beginning of the canine retraction. The pain level was on the 10-cm (100-mm) visual analog scale forms, with 0 (minimum) denoting no pain, while 100 (maximum) denoting sever pain.
canine rotation
Time frame: 4 months
Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other. The change in rotation of the canine will be calculated at each time point.
canine retraction rate
Time frame: 4 months
Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other. The retraction rate will be analyzed monthly and the total amount of canine retraction rate will be measured from cusp tip of the canine T0 to the same point in T4 for both sides.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 40449366Kassas AN, Kamel AM, Mohammad MH, Fouda MAE, Montasser MA. Three-dimensional assessment of mini-implant supported maxillary canine retraction with and without power arm in class II division 1 patients: A split-mouth randomized trial. Int Orthod. 2025 Dec;23(4):101030. doi: 10.1016/j.ortho.2025.101030. Epub 2025 May 30.
Related trials for Power Arm Canine Retraction
Enrolling by invitation
Comparison of Maxillary Canine Retraction Rate With and Without Power Arm
Orthodontic Anchorage, Power Arm Sliding
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-Dimensional Assessment of Maxillary Canine Retraction with Power Arm and Three-Dimensional Assessment of Maxillary Canine Retraction without Power Arm in people with Power Arm Canine Retraction, run by Mansoura University 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 9 inclusion and 8 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 8 Apr 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?
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?
Canine tipping (time frame: 4 months). The study lists 6 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 NCT06352996, 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 8 Apr 2024.