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

NCT05202496 | Completed DMC

• 1 other identifier: Dr Revathi M N
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Angle Class I

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  16th week

Secondary Outcomes (1)

• Measurement of Root resorption

  6 months

Study Arms (2)

Experimental: oral vitamin D supplementation during orthodontic treatment

EXPERIMENTAL

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 : Orthodontic treatment with no intervention

ACTIVE COMPARATOR

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

Procedure: orthodontic treatment

Interventions

Calcitriol 0.25Mcg Cap DRUG

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: oral vitamin D supplementation during orthodontic treatment

orthodontic treatment PROCEDURE

experimental group subjects undergo orthodontic treatment after extraction of premolars

Experimental: oral vitamin D supplementation during orthodontic treatment; control : Orthodontic treatment with no intervention

Eligibility Criteria

• Age: 19 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Pgids,Rohtak

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Malocclusion, Angle Class I

Interventions

Calcitriol; Capsules; Orthodontics

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dosage Forms; Pharmaceutical Preparations; Dentistry

Study Officials

• Rekha Sharma, MDS

  PGIDS,ROHTAK

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: January 21, 2022
• Study Start: November 20, 2019
• Primary Completion: April 30, 2021
• Study Completion: December 31, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

IN (1)