An interventional study of Calcitriol 0.25Mcg Cap and orthodontic treatment in Angle Class I, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Completed at 1 site in India. Open to participants aged 19 Years to 25 Years. Per ClinicalTrials.gov, last updated 2022-01-21.
Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment
This study is to evaluate the effect of vitamin D on the rate of tooth movement by measuring and comparing the extraction space closure during retraction in experimental (vitamin D supplemented) and control groups with a sample size of 24 and having serum vitamin D level (30-40 ng/ml). All subjects undergo orthodontic levelling and alignment after premolar extractions followed by vitamin D supplementation in the experimental group. The rate of canine retraction will be measured in both the groups and CBCT taken in the interval of 6 months before and after intervention to measure root changes
Aims and Objectives: To evaluate the effect of vitamin D on the rate of tooth movement by measuring and comparing the extraction space closure during retraction in experimental (vitamin D supplemented) and control groups. Secondary objective: To compare root resorption in experimental and control group. Setting: Department of Orthodontics and Dentofacial Orthopaedics, PGIDS, Rohtak.
Study Design: Prospective, double blind, randomized clinical study Time frame: Duration of study is one year Population/participant: Inclusion criteria:- Patients with age between 19-25 years with malocclusion requiring bilateral extraction of maxillary 1st premolars in good general health and healthy periodontium.
Exclusion Criteria:- Presence of any systemic/bone/metabolic/hormonal diseases, long-term drug history, pregnant or lactating women, smoking habit, root resorption orany chronic disorders Sample size: A sample size of 10 per group for the present study was calculated to detect a clinical difference of 0.89 with a pooled standard deviation of 0.53 (effect size 1.67) at 95% power and alpha significance level at 0.05.
To compensate for 20% dropouts the final sample size was calculated to be 11 per group (i.e) total sample size will be 24.
Method of study: Patients who fulfill the selection criteria will be selected for the study. After taking the pretreatment records and recording the pretreatment vitamin D levels the patients will be sent for extraction of 1st premolars. Treatment will be initiated by bonding 0.022"slot MBT straight wire appliance. Retraction will be done on 0.019"x 0.025" SS wires using closed coil NiTi springs. Patients of study group will be instructed to take adequate dose of vitamin D3 during phase of space closure. Serum vitamin D levels will be checked at 4th,8th, 12th and 16th weeks and rate of canine retraction will be measured at these time intervals. Root resorption will be measured from CBCT at the end of 6 months Outcome Measures: The outcome variables will be the rate of retraction measured in millimeters. Changes in root length will be measured and compared between the two groups Statistical Analysis: Data will be checked for normality. If it is in normal distribution, intra group comparison will be done by student's t-test between two time points and inter group comparison will be done by using Independent T test between two groups. If it is in non-normal distribution, intra group comparison will be done by Wilcoxon signed rank test and inter group comparison will be done by Mann-Whitney U test.
35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.
This study's enrollment of 24 is below the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.
Browse Malocclusion, Angle Class I studies →Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 213 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
The biological methods include using various chemicals like parathyroid hormone, thyroid hormone, prostaglandins, corticosteroids, relaxin and vitamin D. Due to its important role in bone remodeling, vitamin D is hypothesized to play an important role in accelerating orthodontic tooth movement. experimental group subjects with serum vitamin D levels in the range of 30-40 ng/ml are enrolled
Drug: Calcitriol 0.25Mcg Cap · Procedure: orthodontic treatment
control group subjects with serum vitamin D levels in the range of (30-40 ng/ml) are enrolled
Procedure: orthodontic treatment
After orthodontic levelling and alignment, experimental group subjects are administered one capsule of calcitriol 0.25 mcg on a daily basis during the study period. Also, serum vitamin D levels are monitored at monthly intervals and rate of canine retraction is measured at monthly intervals
Also known as: Rocaltrol
experimental group subjects undergo orthodontic treatment after extraction of premolars
Measurement of rate of canine retraction
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
Time frame: 4th week
Measurement of rate of canine retraction
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
Time frame: 8th week
Measurement of rate of canine retraction
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
Time frame: 12th week
Measurement of rate of canine retraction
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
Time frame: 16th week
Measurement of Root resorption
Root resorption is measured in relation to canine with the help of CBCT taken before and after intervention
Time frame: 6 months
Ran from Nov 2019 to primary completion in Apr 2021, 17 months.
Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's 17 months is below that.
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Calcitriol
Postgraduate Institute of Dental Sciences Rohtak →