- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06352996
Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mansoura, Egypt
- Faculty of Dentistry Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- good oral hygiene
- no systemic disease
- absence of canine morphological abnormalities.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: power arm canine retraction
|
A nickel titanium closed coil spring will be stretched from the mini-implant to the power arm will be used for canine retraction.
|
|
Experimental: canine retraction without power arm
|
A nickel titanium closed coil spring will be stretched from the mini-implant to the canine bracket will be used for canine retraction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
4 months
|
|
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.
|
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.
|
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. |
1 week
|
|
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. |
4 months
|
|
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. |
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Dentist Anas Kassas
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Power Arm Canine Retraction
-
Dow University of Health SciencesCompletedVarying Heights of Power Arm During en Masse RetractionPakistan
-
Ain Shams UniversityCompleted
-
Al-Azhar UniversityCompleted
-
Al-Azhar UniversityActive, not recruiting
-
Cairo UniversityCompleted
-
Mansoura UniversityActive, not recruitingCanine RetractionEgypt
-
Cairo UniversityNot yet recruiting
-
Dow University of Health SciencesCompleted
-
UConn HealthCompleted
-
Cairo UniversityRecruitingRate of Canine RetractionEgypt