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NCT Number: NCT07200349

Clinical Evaluation of Local Calcitriol Delivery on Maxillary Canine Retraction

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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Key information

Age range

13 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Acronym: CALCR25

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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