Canine Retraction Using Different Bracket Slots' Sizes: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Baghdad
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- The rate of movement and/or rotation
Study Overview
Brief Summary
Primary Objective Evaluating the effectiveness of canine retraction in terms of: rate of movement and rotation using 0.020-inch slot and dual-slot systems in comparison with the 0.022-inch slot system.
Secondary Objectives
- Measuring the amount of molar anchorage loss during canine retraction between the different bracket slot appliances.
- Evaluation of alignment efficiency using different bracket slot appliances.
Null Hypothesis There is insignificant difference in the effectiveness of canine retraction with different bracket slot size appliances.
• Evaluation of the bracket slot and archwire dimensions precision
Detailed Description
Study Design This will be a multi-center randomized clinical trial.
Participants Participants will be recruited from subjects attending the Department of Orthodontics in the College of Dentistry, University of Baghdad and some private clinics seeking orthodontic treatment.
Sample Size Calculation Sample size will be calculated using G-power software based upon two previous trials (Mezomo et al., 2011; Moninia et al., 2019) investigating monthly canine retraction rate between conventional-ligated and self-ligating brackets. Using the highest SD and assuming the smallest difference requiring detection in canine retraction velocity to be 0.30 mm/month with an alpha level of 0.05 and power of 80%, a total of 13 canines will be required per group. Therefore, recruiting 13 patients in each group will provide 26 canines per group and this will account for dropout.
Participant Recruitment Patients seeking orthodontic treatment who meet the inclusion criteria will be assessed by the investigator for planning the orthodontic treatment. The patients will be invited to participate in the study and will be given a participant's and/or parents' information sheet to take home with them. Patients will be asked to decide about joining the trial on the next appointment (after at least one week).
Randomization and Sequence Generation Simple randomization will be accomplished with no stratification using a random number generator. A table for the allocation of the participants in the study will be composed (which includes the study number and allocation group) and kept in a sealed envelope. All the documents used for the randomization and allocation sequence generation will be kept away from the clinical environments.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The appliance and archwires will be coded for each patient, so the investigator will be blinded about the size of brackets slot and archwires gauges. Moreover, data measurements and analysis will be carried out blindly too.
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 15 years and above at the start of treatment
- •Molar relationship class II or I bimaxillary proclination
- •Extraction of maxillary first premolar teeth as part of the orthodontic treatment
- •Full set of permanent teeth regardless third molars
- •No systemic diseases
- •Good oral health at the start of treatment.
Exclusion Criteria
- •Orofacial clefting
- •Impacted teeth
- •Special needs patients
- •Patients undergoing orthognathic (jaw) surgery as part of their orthodontic treatment plan
- •Patients with systemic diseases requiring long-term use of Phenytoin, Cyclosporine, anti-inflammatory drugs, Bisphosphonates and systemic corticosteroids
- •Poor oral hygiene, or active periodontal disease.
Outcomes
Primary Outcomes
The rate of movement and/or rotation
Time Frame: 10 months
Evaluating the effectiveness of canine retraction in terms of: rate of movement and/or rotation using 0.020-inch slot and dual-slot systems in comparison with the 0.022-inch slot system.
Secondary Outcomes
- Molar anchorage loss assessment during canine retraction(10 months)
Investigators
Mohammed Nahidh
Principal Investigator
University of Baghdad