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Effect of Systemic Administration of Vitamin D on the Rate of Orthodontic Tooth Movement - A Randomized Control Trial

Primary Purpose

Angle Class I

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Calcitriol 0.25Mcg Cap
orthodontic treatment
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angle Class I

Eligibility Criteria

19 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient in the age group of 19-25 years .
  2. Good general health status.
  3. Healthy periodontium
  4. Absence of root resorption.
  5. Absence of any chronic disorders
  6. No history of orthodontic treatment.

Exclusion Criteria:

  1. Presence of any signs and symptoms of gingival and periodontal diseases.
  2. Any Systemic/Bone/metabolic/hormonal disease illness known to affect the outcome of orthodontic therapy or requiring administration of vitamin D
  3. Any kind of prolonged drug administration (chronic drug intake)
  4. Pregnant or lactating women.
  5. Smoking habit.

Sites / Locations

  • Pgids,Rohtak

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: oral vitamin D supplementation during orthodontic treatment

control : Orthodontic treatment with no intervention

Arm Description

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

control group subjects with serum vitamin D levels in the range of (30-40 ng/ml) are enrolled

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Measurement of Root resorption
Root resorption is measured in relation to canine with the help of CBCT taken before and after intervention

Full Information

First Posted
January 9, 2022
Last Updated
January 9, 2022
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05202496
Brief Title
Effect of Systemic Administration of Vitamin D on the Rate of Orthodontic Tooth Movement - A Randomized Control Trial
Official Title
Effect of Oral Systemic Administration of Vitamin D on the Rate of Orthodontic Tooth Movement - A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angle Class I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: oral vitamin D supplementation during orthodontic treatment
Arm Type
Experimental
Arm Description
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
Arm Title
control : Orthodontic treatment with no intervention
Arm Type
Active Comparator
Arm Description
control group subjects with serum vitamin D levels in the range of (30-40 ng/ml) are enrolled
Intervention Type
Drug
Intervention Name(s)
Calcitriol 0.25Mcg Cap
Other Intervention Name(s)
Rocaltrol
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
orthodontic treatment
Intervention Description
experimental group subjects undergo orthodontic treatment after extraction of premolars
Primary Outcome Measure Information:
Title
Measurement of rate of canine retraction
Description
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
Title
Measurement of rate of canine retraction
Description
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
Title
Measurement of rate of canine retraction
Description
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
Title
Measurement of rate of canine retraction
Description
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
Secondary Outcome Measure Information:
Title
Measurement of Root resorption
Description
Root resorption is measured in relation to canine with the help of CBCT taken before and after intervention
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient in the age group of 19-25 years . Good general health status. Healthy periodontium Absence of root resorption. Absence of any chronic disorders No history of orthodontic treatment. Exclusion Criteria: Presence of any signs and symptoms of gingival and periodontal diseases. Any Systemic/Bone/metabolic/hormonal disease illness known to affect the outcome of orthodontic therapy or requiring administration of vitamin D Any kind of prolonged drug administration (chronic drug intake) Pregnant or lactating women. Smoking habit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rekha Sharma, MDS
Organizational Affiliation
PGIDS,ROHTAK
Official's Role
Study Chair
Facility Information:
Facility Name
Pgids,Rohtak
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

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Effect of Systemic Administration of Vitamin D on the Rate of Orthodontic Tooth Movement - A Randomized Control Trial

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