Effect of Systemic Administration of Vitamin D on the Rate of Orthodontic Tooth Movement - A Randomized Control Trial
Condition: Angle Class I
MeSH terms: Malocclusion, Angle Class I
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Calcitriol 0.25Mcg Cap; orthodontic treatment
Intervention type(s): Drug; Procedure
Intervention description(s): 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; experimental group subjects undergo orthodontic treatment after extraction of premolars
Other intervention name(s): Rocaltrol
Intervention MeSH terms: Calcitriol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment