Maxillary Canine RetractionCALCR25NCT07200349
Clinical Evaluation of Local Calcitriol Delivery on Maxillary Canine Retraction
A study testing Calcitriol Delivery in people with Maxillary Canine Retraction and Local Calcitriol Delivery, run by Al-Azhar University.
Trial summary
This study will evaluate the effect of locally applied Calcitriol on dental and skeletal changes during upper canine retraction. It is a split-mouth randomized clinical trial, where Calcitriol will be locally applied on one side of the maxilla, and the other side will serve as control. Read more about this study
- Who is it for?
- Ages 13 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Canine Retraction, Local Calcitriol Delivery, Orthodontic Tooth Movement
- What is being tested?
- Calcitriol Delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to Oct 2026
- Phase
- Interventional
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Presence of class I malocclusion requiring bilateral extraction of the maxillary first premolars and subsequent canine retraction.
- Presence of class II malocclusion requiring bilateral extraction of the maxillary first premolars and subsequent canine retraction.
- Age range between 13 and 35 years to include both adolescent and adult patients suitable for orthodontic treatment.
- Presence of permanent dentition.
- Good oral hygiene.
Who cannot join
- History of chronic systemic disease.
- Presence of active gingival or periodontal disease.
- Known allergy or hypersensitivity to vitamin D.
- Pregnancy or lactation.
- History of previous orthodontic treatment.
- Presence of craniofacial anomalies affecting bone physiology.
About this study
This study will evaluate the effect of locally applied Calcitriol on dental and skeletal changes during upper canine retraction. It is a split-mouth randomized clinical trial, where Calcitriol will be locally applied on one side of the maxilla, and the other side will serve as control.
Read the detailed description
Orthodontic tooth movement depends on bone remodeling. This study investigates if Calcitriol, the active form of vitamin D3, can affect this process when applied locally during upper canine retraction. The study is designed as a split-mouth randomized clinical trial. Patients needing maxillary first premolar extraction will be included. Calcitriol will be locally applied on one side, and the other will serve as a control. The study will evaluate dental and skeletal changes to see if Calcitriol improves treatment outcomes.
- Being tested
- Calcitriol Delivery
- Keywords
- Calcitriol, Vitamin D3, Canine Retraction, Split-mouth Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitriol DeliveryDrug
Local delivery of Calcitriol (active form of vitamin D3) to one side of the maxillary canine area during orthodontic treatment. The aim is to assess its effect on dental and skeletal changes during canine retraction in a split-mouth design.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Sufficient Group | Experimental | Patients with normal serum vitamin D levels. Each patient receives a local Calcitriol delivery on one side of the maxilla, and the other side serves as control (split-mouth). Receives: Drug: Calcitriol Delivery |
| Vitamin D Deficient Group | Experimental | Patients with normal serum vitamin D levels. Each patient receives a local Calcitriol delivery on one side of the maxilla, and the other side serves as control (split-mouth). Receives: Drug: Calcitriol Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of maxillary canine retraction (mm) assessed on CBCT scans
The amount of maxillary canine movement will be assessed using cone-beam computed tomography (CBCT). Measurements will be expressed in millimeters
Measured: T0: immediately before maxillary canine retraction. T1: after completion of canine retraction (approximately 4 months - 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Canine RetractionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel design with two groups based on Vitamin D status. Each participant receives a split-mouth intervention with Calcitriol on one side and no treatment on the other side
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Taha Ahmed Hassan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200349
- Sponsor's protocol ID
- AZH2025CalcitriolCR
- Acronym
- CALCR25
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a university-based academic study conducted as part of a master's thesis. There is no plan to share individual participant data due to the absence of a data-sharing agreement or external funding
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Local Calcitriol Delivery on Maxillary Canine Retraction
- ClinicalTrials.gov ID
- NCT07200349
- Acronym / sponsor ID
- CALCR25 / AZH2025CalcitriolCR
- Keywords
- Calcitriol, Vitamin D3, Canine Retraction, Split-mouth Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Oct 2025 (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.
This study will evaluate the effect of locally applied Calcitriol on dental and skeletal changes during upper canine retraction. It is a split-mouth randomized clinical trial, where Calcitriol will be locally applied on one side of the maxilla, and the other side will serve as control.
Detailed description
Orthodontic tooth movement depends on bone remodeling. This study investigates if Calcitriol, the active form of vitamin D3, can affect this process when applied locally during upper canine retraction. The study is designed as a split-mouth randomized clinical trial. Patients needing maxillary first premolar extraction will be included. Calcitriol will be locally applied on one side, and the other will serve as a control. The study will evaluate dental and skeletal changes to see if Calcitriol improves treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel design with two groups based on Vitamin D status. Each participant receives a split-mouth intervention with Calcitriol on one side and no treatment on the other side
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Sufficient Group | Experimental | Drug: Calcitriol DeliveryPatients with normal serum vitamin D levels. Each patient receives a local Calcitriol delivery on one side of the maxilla, and the other side serves as control (split-mouth). |
| Vitamin D Deficient Group | Experimental | Drug: Calcitriol DeliveryPatients with normal serum vitamin D levels. Each patient receives a local Calcitriol delivery on one side of the maxilla, and the other side serves as control (split-mouth). |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Presence of class I malocclusion requiring bilateral extraction of the maxillary first premolars and subsequent canine retraction.
- Presence of class II malocclusion requiring bilateral extraction of the maxillary first premolars and subsequent canine retraction.
- Age range between 13 and 35 years to include both adolescent and adult patients suitable for orthodontic treatment.
- Presence of permanent dentition.
- Good oral hygiene.
Key exclusion criteria (6 listed)
- History of chronic systemic disease.
- Presence of active gingival or periodontal disease.
- Known allergy or hypersensitivity to vitamin D.
- Pregnancy or lactation.
- History of previous orthodontic treatment.
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 |
|---|---|---|
| Calcitriol DeliveryLocal delivery of Calcitriol (active form of vitamin D3) to one side of the maxillary canine area during orthodontic treatment. The aim is to assess its effect on dental and skeletal changes during canine retraction in a split-mouth design. | Drug | Vitamin D Deficient Group, Vitamin D Sufficient Group |
Primary outcome
Amount of maxillary canine retraction (mm) assessed on CBCT scans
Time frame: T0: immediately before maxillary canine retraction. T1: after completion of canine retraction (approximately 4 months - 6 months)
The amount of maxillary canine movement will be assessed using cone-beam computed tomography (CBCT). Measurements will be expressed in millimeters
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 1 Oct 2025.
- Individual participant dataSharing planned: No. This is a university-based academic study conducted as part of a master's thesis. There is no plan to share individual participant data due to the absence of a data-sharing agreement or external funding
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Calcitriol Delivery in people with Maxillary Canine Retraction and Local Calcitriol Delivery, run by Al-Azhar University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of maxillary canine retraction (mm) assessed on CBCT scans (time frame: T0: immediately before maxillary canine retraction. T1: after completion of canine retraction (approximately 4 months - 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.