Actively Recruiting

Phase Not Applicable
Age: 13Years - 20Years
All Genders
Healthy Volunteers
ID07455656

Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction: A Prospective Clinical Study

Led by Al-Azhar University · Updated on 2026-03-06

16

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of locally administered vitamin D3 combined with a minimally invasive surgical technique called corticision on accelerating orthodontic canine retraction. This prospective clinical study aims to shorten orthodontic treatment time by speeding up tooth movement, which can reduce risks like gum inflammation and tooth decay. The study compares this combined approach to conventional orthodontic treatment in patients aged 13 to 20 years with specific dental conditions. Participants will be randomly assigned to one of two groups: one group will receive local injections of vitamin D3 alongside corticision, a surgical method to stimulate bone remodeling, while the other group will undergo conventional treatment without these interventions. Vitamin D3 injections are given four times during the 12-week canine retraction period at set intervals. Tooth movement and bone density changes will be closely monitored during this time. Patients will be followed over three months with assessments including photographs, dental X-rays, study models, and cone beam computed tomography (CBCT) scans before and after treatment. Researchers will measure the rate and amount of canine movement as well as changes in alveolar bone density. Regular evaluations will ensure treatment progress and patient compliance. The primary outcome is the rate of canine retraction from baseline to three months, with secondary outcomes focusing on bone density changes in the treated area.

CONDITIONS

Brief Title

Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction

Who Can Participate

Age: 13Years - 20Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Orthodontic patients referred for therapeutic extraction of bilateral maxillary first premolars (Angle Class II division 1 cases, with crowding and bimaxillary protrusion)
  • Fully erupted permanent teeth except third molars
  • Age between 13 and 20 years
  • No previous orthodontic treatment
  • Good oral and general health
  • No systemic disease or regular medication that could interfere with or affect orthodontic tooth movement
Not Eligible

You will not qualify if you...

  • Patients with impacted canine teeth
  • Patients with severe crowding
  • Patients with untreated tooth decay or any endodontic lesions
  • Patients with thyroid, parathyroid, kidney, or liver disease

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 12 weeks

Participants receive local application of vitamin D3 combined with corticision to accelerate orthodontic canine retraction. The vitamin D3 injections occur at the start, and at 4, 8, and 12 weeks of treatment.

4 visits for vitamin D3 injections and evaluations at baseline, 4, 8, and 12 weeks (in-person)

Follow-up

Duration - Post 12 weeks after treatment completion

Participants are followed up to evaluate the progress of tooth movement and the changes in alveolar bone density using imaging and study models taken before and after the treatment period.

1 visit for final evaluation and imaging (in-person)

Trial Site Locations

Total: 1 location

1

Orthodontic Outpatient Clinic, Faculty of Dental Medicine, Al-Azhar University

Cairo, Cairo Governorate, Egypt, 11651

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Research Team

M

Mahmoud Elsaid Elsayed E Mahmoud Elsaid, BDS

D

Dr. Mahmoud Fathy Aboelmahasen F Dr. Mahmoud F. Aboelmahasen, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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