Malocclusion of Anterior TeethPhase 1NCT07479290
Effect of Local Use of Vitamin D on the Rate of Canine Distillization: a Split Mouth Randomized Control Trial
A Phase 1 study testing Experimental: 1,25 DHC injection in people with Malocclusion of Anterior Teeth, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Malocclusion of Anterior Teeth
- What is being tested?
- Experimental: 1,25 DHC injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with permanent dentition
- Angles class 1,class II dental malocclusion, indicated for bilateral maxillary first premolar extraction
- minimum 5 of extraction space
Who cannot join
- several craniofacial deformities such as cleft lip and palate
- history of bone disease such as osteoporosis or diabetes
- pregnant and lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Islamabad
Islamabad, Federal, 44000
Syeda Hareem Bukhari, BDS, Resident Orthodontics, 923207351191, hareembukhari202@gmail.com
About this study
Official title: Effect Of Local Use Of 1,25 Dihydroxycholecalciferol on Rate of Canine Distillization: A Split Mouth Randomized Control Trial
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.
Read more
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.
- Conditions
- Malocclusion of Anterior Teeth
- Being tested
- Experimental: 1,25 DHC injection, Placebo: plain DMSO solvent
- Keywords
- Vitamin D, Malocclusion, accelerated Orthodontics, 1,25 dihydroxycholecalciferol, canine distillization
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: 1,25 DHC injectionDietary supplement
Also called Calcitriol, Vitamin D
Experimental: participants will receive 1,25 DHC injection mixed with solvent DMSO
Placebo: plain DMSO solventDrug
Also called DMSO
Control: placebo: participants in this arm will receive plain DMSO solvent
| Study group | Role | What they receive |
|---|---|---|
| Control Group: placebo | Placebo comparator | Participants in this arm will receive only placebo DMSO solution Receives: Drug: Placebo: plain DMSO solvent |
| Experimental group: 1,25 DHC in DMSO | Experimental | Experimental group will receive active vit D injection mixed with DMSO liquid Receives: Dietary Supplement: Experimental: 1,25 DHC injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start20 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malocclusion of Anterior TeethStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blinded, split mouth parallel group randomized control trial with two arms. Patients will be randomly assigned to each group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
- Investigators
- Syeda Hareem Bukhari, BDS, Resident Orthodontics, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479290
- Sponsor's protocol ID
- FUCD-Ortho-2502
- Status last verified
- Feb 2026
- First submitted
- 18 Dec 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual patient proformas will be shared containing each measurement of canine tooth movement with time
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Local Use Of 1,25 Dihydroxycholecalciferol on Rate of Canine Distillization: A Split Mouth Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07479290
- Acronym / sponsor ID
- FUCD-Ortho-2502
- Conditions
- Malocclusion of Anterior Teeth
- Keywords
- Vitamin D, Malocclusion, accelerated Orthodontics, 1,25 dihydroxycholecalciferol, canine distillization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- double blinded, split mouth parallel group randomized control trial with two arms. Patients will be randomly assigned to each group
| Arm | Type | Receives |
|---|---|---|
| Control Group: placebo | Placebo comparator | Drug: Placebo: plain DMSO solventParticipants in this arm will receive only placebo DMSO solution |
| Experimental group: 1,25 DHC in DMSO | Experimental | Dietary Supplement: Experimental: 1,25 DHC injectionExperimental group will receive active vit D injection mixed with DMSO liquid |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with permanent dentition
- Angles class 1,class II dental malocclusion, indicated for bilateral maxillary first premolar extraction
- minimum 5 of extraction space
Key exclusion criteria (3 listed)
- several craniofacial deformities such as cleft lip and palate
- history of bone disease such as osteoporosis or diabetes
- pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: 1,25 DHC injectionAlso: Calcitriol, Vitamin DExperimental: participants will receive 1,25 DHC injection mixed with solvent DMSO | Dietary supplement | Experimental group: 1,25 DHC in DMSO |
| Placebo: plain DMSO solventAlso: DMSOControl: placebo: participants in this arm will receive plain DMSO solvent | Drug | Control Group: placebo |
Primary outcome
complete canine distillization
Time frame: 1 years
patients will be given 1,25 DHC injection at 3 time points and complete canine movement will be measured on study casts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Results publication: PubMed 33523325Arqub 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.
- Individual participant dataSharing planned: Yes. individual patient proformas will be shared containing each measurement of canine tooth movement with time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Syeda Hareem Bukhari, BDS, Resident Orthodontics principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Experimental: 1,25 DHC injection in people with Malocclusion of Anterior Teeth, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shoaib Rahim, FCPS (923215097582, clinicaltrials.fucd@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete canine distillization (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07479290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.