Clinical Evaluation of Local Calcitriol Delivery on Maxillary Canine Retraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Maxillary Canine Retraction Local Calcitriol Delivery Orthodontic Tooth Movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D Sufficient Group

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).

Group Type EXPERIMENTAL

Calcitriol Delivery

Intervention Type 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

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).

Group Type EXPERIMENTAL

Calcitriol Delivery

Intervention Type 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.

Interventions

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Calcitriol 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes