Clinical Evaluation of Local Calcitriol Delivery on Maxillary Canine Retraction

Not Applicable

Not yet recruiting

• Conditions: Maxillary Canine Retraction; Local Calcitriol Delivery; Orthodontic Tooth Movement
• Interventions: Drug: Calcitriol Delivery

• Registration Number: NCT07200349
• Lead Sponsor: Al-Azhar University

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.

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 Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2025-11-01
• Primary Completion: 2026-09
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Presence of class I malocclusion requiring bilateral extraction of the maxillary first premolars and subsequent canine retraction.
2. Presence of class II malocclusion requiring bilateral extraction of the maxillary first premolars and subsequent canine retraction.
3. Age range between 13 and 35 years to include both adolescent and adult patients suitable for orthodontic treatment.
4. Presence of permanent dentition.
5. Good oral hygiene.

Exclusion Criteria

1. History of chronic systemic disease.
2. Presence of active gingival or periodontal disease.
3. Known allergy or hypersensitivity to vitamin D.
4. Pregnancy or lactation.
5. History of previous orthodontic treatment.
6. Presence of craniofacial anomalies affecting bone physiology.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D Sufficient Group	Calcitriol Delivery	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).
Vitamin D Deficient Group	Calcitriol Delivery	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).

Primary Outcome Measures

Name	Time	Method
Amount of maxillary canine retraction (mm) assessed on CBCT scans	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