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Not yet recruiting NCT07200349

Clinical Evaluation of Local Calcitriol Delivery on Maxillary Canine Retraction

No phase Interventional Maxillary Canine Retraction Local Calcitriol Delivery Orthodontic Tooth Movement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Calcitriol Delivery.
Who it may be relevant to
Registry conditions: Maxillary Canine Retraction, Local Calcitriol Delivery, Orthodontic Tooth Movement. Basic parameters: 13 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Drug 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.

Primary outcome measures

  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07200349 · AZH2025CalcitriolCR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗