- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06481761
The Effectiveness of Double-slot Brackets Versus Single-slot Brackets on the Rate of Canine Retraction
The Effectiveness of Double-slot Brackets Versus Single-slot Brackets on the Rate of Canine Retraction: A Randomized Clinical Trial
The aim of this Randomized clinical trial is to compare the efficacy of the double slot brackets compared to single slot-brackets in producing a controlled rate of upper canine retraction into premolar extraction space.
patients will be randomly divided into one of the two groups, CBCT (cone beam computed tomography) and dental models will be taken for each patient Pre-retraction and following the study completion.
The rate of retraction will be evaluated for both groups as well as Amount of canine root movement and molar anchorage loss will be also assessed.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eligible patients will be examined for fulfilling the inclusion criteria. All the recruited patients need extraction of upper first premolars followed by canine retraction with maximum anchorage.
The patients will be randomly allocated to one of the two groups; either Double slot brackets or single slot-brackets group.
In Double slot bracket group, Canine retraction will be made on two 0.016'' StSt (stainless steel) round wires, each in one of the slots of the double slot brackets. while in single slot-bracket group, Retraction will be made on one 0.017''×0.025'' rectangular StSt arch wire .
The patients will be seen on a monthly basis for follow up visit for reactivation of retraction to maintain constant force during the study. An impression will be taken for the patients every visit, fabricated dental models will be digitally scanned. The scanned models will be used to monitor the rate of canine retraction.
Every patient will be asked to take a CBCT image of the upper arch pre Retraction and after the completion of study duration (3 months). After data collection, assessors will carry on the measurements blindly. Statistical analysis of the data will be done and the results will be compared to evaluate the effectiveness of both techniques for canine retraction.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt, 12613
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Good oral hygiene.
- Adult Male or Female patients with an age range of 16-26 years old.
- Full set of permanent dentition(excluding third molar).
- Any kind of malocclusion requiring first premolar extraction and canine retraction.
- Patients with type/pattern of crowding that allows leveling and alignment before premolar extraction
Exclusion Criteria:
- History of previous orthodontic treatment.
- Craniofacial deformity.
- Systematic disease or administrating drugs affecting tooth movement.
- Poor oral health.
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 |
|---|---|
|
Active Comparator: Single-slot brackets
Bonding of the upper arch up to second molars with Roth prescription 0.022x.028"
single slot brackets (MINI MS-American orthodontics)
|
Miniscrews will be inserted in the buccal alveolar bone between first and second molars bilaterally and ligated to second premolar. Canine Retraction using Nickel titanium closed-coil springs delivering a force of 150 gram, extending the spring between the canine and first molar hooks. retraction on single 0.017x0.022'' Stainless steel wire. Re-activation of the coil spring will be done in the follow up visits to maintain a constant force through the study. |
|
Experimental: Double-slot brackets
Double slot brackets (SORTECH-South Orthodontic Technology) will be Bonded on the upper arch up to the second molars.
The brackets are of Roth prescription & have two slots, cervical 0.018x.025"
slot and incisal/occlusal 0.022x.028"
slot
|
Miniscrews will be inserted in the buccal alveolar bone between first and second molars bilaterally and ligated to second premolar. Canine Retraction using Nickel titanium closed-coil springs delivering a force of 150 gram, extending the spring between the canine and first molar hooks. retraction on double 0.016'' Stainless steel round wires in both slots of the double slot brackets. Re-activation of the coil spring will be done in the follow up visits to maintain a constant force through the study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of canine retraction
Time Frame: 3 months
|
millimeters through superimposed digital models taken for each patient monthly at the follow up visits.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Molar cusp anchorage loss
Time Frame: 3 months
|
millimeters through superimposed digital models taken for each patient monthly at the follow up visits.
and pre and post retraction CBCT images
|
3 months
|
|
Amount of canine root movement
Time Frame: 3 months
|
millimeters through pre and post retraction CBCT (cone beam computed tomography) images of the upper arch
|
3 months
|
|
Total distance moved by the maxillary canine tip
Time Frame: 3 months
|
movement in millimeters through superimposed pre- and post-retraction digital models.
|
3 months
|
|
the change in Maxillary canine Torque
Time Frame: 3 months
|
angular change through comparing pre- and post-retraction CBCT
|
3 months
|
|
change in maxillary canine tipping
Time Frame: 3 months
|
angular change through comparing pre- and post-retraction CBCT
|
3 months
|
|
The changes in maxillary canine rotation
Time Frame: 3 months
|
angular change through superimposed pre- and post-retraction digital models.
|
3 months
|
|
Amount of maxillary canine root resorption
Time Frame: 3 months
|
millimeters through pre and post retraction CBCT (cone beam computed tomography) images of the upper arch
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amr R El Beialy, Assoc.Prof, Orthodontic department, Faculty of Dentistry, Cairo University
- Study Director: Nada O El Zawahry, lecturer, Orthodontic department, Faculty of Dentistry, Cairo University
- Study Director: Noha A El Ashmawi, lecturer, Orthodontic department, Faculty of Dentistry, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Orth3-3-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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