Local Calcitriol Delivery, Maxillary Canine Retraction, Orthodontic Tooth Movement
Conditions
Keywords
Calcitriol, Vitamin D3, Canine Retraction, Split-mouth Trial
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.
Interventions
DRUGCalcitriol Delivery
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.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
13 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed