Clinical Evaluation of Local Calcitriol Delivery on Maxillary Canine Retraction

NCT07200349 | Not Yet Recruiting

• 1 other identifier: AZH2025CalcitriolCR
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Maxillary Canine Retraction; Local Calcitriol Delivery; Orthodontic Tooth Movement

Keywords

Calcitriol; Vitamin D3; Canine Retraction; Split-mouth Trial

Outcome Measures

Primary Outcomes (1)

• 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

  T0: immediately before maxillary canine retraction. T1: after completion of canine retraction (approximately 4 months - 6 months)

Study Arms (2)

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).

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).

Drug: Calcitriol Delivery

Interventions

Calcitriol Delivery DRUG

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.

Vitamin D Deficient Group; Vitamin D Sufficient Group

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Researcher (Master's Candidate)

Model Details: 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

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: October 1, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share