Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-20
SponsorAl-Azhar University
About this trial
To study the effect vitamin D effect on orthodontic tooth movement when used in combination with coticision technique, independent t test or an equivalent non-parametric test will be used for comparison. According to a previous study by (S. T. Varughese, et al. (2019) , "Effect of vitamin D on canine distalization and alveolar bone density using multi-slice spiral CT: a randomized controlled trial
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Orthodontic patients referred for therapeutic extraction of bilateral maxillary first premolars (Angle Class II division 1 cases, with crowding and bimaxillary protrusion).
Fully erupted permanent teeth (except third molar).
Age 13-20 patients.
No previous orthodontic treatment.
Disqualifiers
Patients with impacted canines.
Patients with severe crowding.
Patients with untreated decay or any endodontic lesions.
Patients with thyroid, parathyroid, or renal and liver disease.
Trial design
Design model
Parallel
Treatments tested in this trial
patients will receive local application of vitamin D3 combined with corticision
DrugAdministration of the Solution at eexperimental side: One milliliter of was injected into the buccal vestibule at the level of the distal margin of the root of the canine. One milliliter of (ONE ALPHA 2 MCG / ML 10 AMP 0.5 ML Leo Pharmaceutical products Ballerup - Denmark. Imported by: Egyptian Company for Drug Trading) was injected four times during treatment on the the beginning (T0), 4 weeks (T1), 8 weeks (T2), and 12 weeks (T3) of canine retraction on both sides according to Varughese, et al. " Participants were evaluated from the beginning (T0), 4 weeks (T1), 8 weeks (T2), and 12 weeks (T3) of canine distalization. At these appointments, impressions were made to obtain the study models. Multi-slice spiral computed tomography scans were taken at T0 and T3 to measure the changes in bone density following canine distalization. The primary outcome was to evaluate the rate and total amount of canine distalization as well as anchorage loss in the maxillary arch. All study measurements
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: patients will receive local application of vitamin D3 combined with corticisionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of canine retraction
The linear distance of canine movement (in millimeters) was measured from a fixed reference point on dental casts or digital models at baseline and monthly intervals to determine the acceleration effect of local vitamin D3 administration and cortisone.
Time frame
baseline to 3 months after initiation of canine retractionSecondary outcomes
1
evaluate the changes in the alveolar bone density
evaluate the changes in the alveolar bone density (axial section) in the maxillary arch. It was measured in the alveolar bone on the experimental and control sides at the region distal to canine root, at the beginning and the 12th week (BX) of canine distalization. The MSCT (HiSpeed NXI MultiSlice CT system GE Medical system) parameters used were 0° gantry tilt, high-resolution bone Kernel, 0.5 mm nominal slice thickness, 120 kV, and 120 mA. The measurements were calculated using Advantage Workstation software (AW-Version 4.3) in HU. The CT sections were taken 3-5 mm apical from the alveolar bone crest. At each axial section, the density at the center point12 of the buccal cortical bone (BC), cancellous bone (C), and palatal cortical bone (PC) was measured. The density of the cancellous bone was measured at the trabeculae, located halfway buccolingually between the buccal and palatal cortical plates."(33)
Time frame
baseline to 3 months after initiation of canine retractionSponsors and contacts
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Source ClinicalTrials.gov