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RecruitingNCT07479290Updated Mar 18, 2026

Effect of Local Use of Vitamin D on the Rate of Canine Distillization: a Split Mouth Randomized Control Trial

A Phase 1 interventional study of Experimental: 1,25 DHC injection and Placebo: plain DMSO solvent in Malocclusion of Anterior Teeth, sponsored by Foundation University Islamabad. Recruiting at 1 site in Pakistan. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Foundation University Islamabad · Phase 1, Interventional, and Supportive care

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
13 Years and older
Sex
All
01

Study summary

Orthodontic treatment (OT) is characterized as a lengthy procedure and enormous effort has been harnessed to shorten the OT duration using either surgical or non-surgical approaches. With the emerging concept of "accelerated orthodontics," scientific interest has been focused on chemical and electrical stimuli in combination with mechanical forces for rapid bone turnover and more stable results. Given the role of cytokines, parathyroid hormone, active vitamin D3 (1,25 dihydroxycholecalciferol) in bone regeneration, several studies have been conducted in which exogenous biological molecules have been locally administrated in order to stimulate orthodontic tooth movement.

Vitamin D (Vit-D) plays a significant role in bone biology and remodeling.There are two primary forms of Vit-D: 25-OHD (25-hydroxyvitamin D) and 1,25 DHC (1,25-dihydroxycholecalciferol) which is the active form.

1,25 DHC is a potent stimulator of osteoclastic activity by inducing differentiation as well as increasing the activity of osteoclasts. It is also known to work in a dose-dependent way. Although it has a 2-3-hour plasma half-life, its effects on cells might last for days. Injecting the active form of Vitamin D can increase tooth movement, decrease the treatment time of fixed appliances and maintain the integrity of the bone.

In the past researches have been done on cats and rodents on the effect of intraligamentary administration of vitamin D3 on tooth movement. Studies performed on human beings are few and inconclusive. Two out of the four studies done on humans were cross-sectional and investigated the role of active vitamin D on external apical root resorption. The other two clinical trials used split-mouth technique and examined the impact of local CTL administration on tooth movement rate, both demonstrating level 1 of evidence and high recommendation. Al-Hasani and colleagues reported that a low dose of 25 picogram/mL produced a higher rate of OTM, with no statistically significant difference between the study and control sides in 15 patients involved in the study. However, Iosub Ciur and colleagues reported 70% acceleration in the OTM when using higher 42 picogram/mL local dose of vit D, but the number of patients was extremely low and not adequate(n=4) in this study. The purpose of our study is to evaluate if higher doses of local vitamin D can accelerate tooth movement in adequate number of adult patients. If vitamin D in our population of adult patients can accelerate tooth movement, then it can allow for more predictable treatment outcome during fixed orthodontic therapy.

Read the detailed description

The main purpose of this study is to see if we can accelerate canine retraction by injecting Vit D in the distal side of canine after extraction of premolar.

30 patients will be taken for this study matching the inclusion criteria and their maxillary arch will be divided into two sides: study side and control side by computer generated randomisation as it is a split mouth randomised control trial. After bilateral extractions of maxillary premolars, the study side will be injected with vitamin D (active form 1,25 DHC) in a solution of DMSO and the control side will be injected with plain DMSO (placebo) at three time points T1( after extraction), T2 (one month after), T3 ( two months after). Canine retraction in the extraction space will be measured by taking impressions at each timepoint and measuring the distance on study casts.

02

Conditions studied

  • Malocclusion of Anterior Teeth

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Keywords

  • Vitamin D
  • Malocclusion
  • accelerated Orthodontics
  • 1,25 dihydroxycholecalciferol
  • canine distillization
03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 30 is below the median of 37 across 242 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Foundation University Islamabad is the lead sponsor of 255 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient with permanent dentition
  • Angles class 1,class II dental malocclusion, indicated for bilateral maxillary first premolar extraction
  • minimum 5 of extraction space

Exclusion criteria

Exclusion Criteria:

  • several craniofacial deformities such as cleft lip and palate
  • history of bone disease such as osteoporosis or diabetes
  • pregnant and lactating women
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Placebo comparator
    Control Group: placebo

    Participants in this arm will receive only placebo DMSO solution

    Drug: Placebo: plain DMSO solvent

  • Experimental
    Experimental group: 1,25 DHC in DMSO

    Experimental group will receive active vit D injection mixed with DMSO liquid

    Dietary Supplement: Experimental: 1,25 DHC injection

Interventions

  • Experimental: participants will receive 1,25 DHC injection mixed with solvent DMSO

    Also known as: Calcitriol, Vitamin D

  • DrugPlacebo: plain DMSO solvent

    Control: placebo: participants in this arm will receive plain DMSO solvent

    Also known as: DMSO

06

What researchers measure

Primary outcomes

  1. complete canine distillization

    patients will be given 1,25 DHC injection at 3 time points and complete canine movement will be measured on study casts

    Time frame: 1 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Arqub SA, Gandhi V, Iverson MG, Ahmed M, Kuo CL, Mu J, Dutra E, Uribe F. The effect of the local administration of biological substances on the rate of orthodontic tooth movement: a systematic review of human studies. Prog Orthod. 2021 Feb 1;22(1):5. doi: 10.1186/s40510-021-00349-5. PubMed 33523325 ↗

Individual participant data

Plan to share: Yes — individual patient proformas will be shared containing each measurement of canine tooth movement with time

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: 15/05/2026 till forever

Access criteria: IPD document will be shared with the journal and will be available to all on request

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2026 (actual). Primary completion is estimated for Dec 2027, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2025
First posted
Mar 18, 2026
StartActual
Feb 20, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Mar 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07479290
Responsible party
Shoaib Rahim (Associate Professor, Foundation University Islamabad) — Principal investigator
First posted
Mar 18, 2026
Start date
Feb 20, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Mar 18, 2026

Study contacts

Dr. Shoaib Rahim, FCPS
Contact
clinicaltrials.fucd@fui.edu.pk
923215097582
Dr Syeda Hareem Bukhari, BDS, Resident Orthodontics
Contact
hareembukhari202@gmail.com
923207351191
Syeda Hareem Bukhari, BDS, Resident Orthodontics
principal investigator · Foundation University Islamabad

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Calcitriol

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