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

NCT07455656 | Recruiting DMC

• 1 other identifier: AZU-ORHO-CR-24
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effect vitamin D effect on orthodontic tooth movement when used in combination with coticision technique, independent t test or an equivalent non-parametric test will be used for comparison. According to a previous study by (S. T. Varughese, et al. (2019) , "Effect of vitamin D on canine distalization and alveolar bone density using multi-slice spiral CT: a randomized controlled trial

Conditions

Malocclusions; Canine Retraction

Keywords

Orhodontic tooth movement; Canine retraction; Extraction first premolars

Outcome Measures

Primary Outcomes (1)

• Rate of canine retraction

  The linear distance of canine movement (in millimeters) was measured from a fixed reference point on dental casts or digital models at baseline and monthly intervals to determine the acceleration effect of local vitamin D3 administration and cortisone.

  baseline to 3 months after initiation of canine retraction

Secondary Outcomes (1)

• evaluate the changes in the alveolar bone density

  baseline to 3 months after initiation of canine retraction

Study Arms (2)

patients will receive local application of vitamin D3 combined with corticision

EXPERIMENTAL

patients will receive local application of vitamin D3 combined with corticision

Drug: patients will receive local application of vitamin D3 combined with corticision

Control

NO INTERVENTION

patients will receive conventional treatment

Interventions

patients will receive local application of vitamin D3 combined with corticision DRUG

Administration of the Solution at eexperimental side: One milliliter of was injected into the buccal vestibule at the level of the distal margin of the root of the canine. One milliliter of (ONE ALPHA 2 MCG / ML 10 AMP 0.5 ML Leo Pharmaceutical products Ballerup - Denmark. Imported by: Egyptian Company for Drug Trading) was injected four times during treatment on the the beginning (T0), 4 weeks (T1), 8 weeks (T2), and 12 weeks (T3) of canine retraction on both sides according to Varughese, et al. " Participants were evaluated from the beginning (T0), 4 weeks (T1), 8 weeks (T2), and 12 weeks (T3) of canine distalization. At these appointments, impressions were made to obtain the study models. Multi-slice spiral computed tomography scans were taken at T0 and T3 to measure the changes in bone density following canine distalization. The primary outcome was to evaluate the rate and total amount of canine distalization as well as anchorage loss in the maxillary arch. All study measurements

patients will receive local application of vitamin D3 combined with corticision

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 molar).
• Age 13-20 patients.
• No previous orthodontic treatment.
• Good oral and general health.
• No systemic disease or regular medication that could interfere with and/or affect orthodontic teeth movement.

You may not qualify if:

• Patients with impacted canines.
• Patients with severe crowding.
• Patients with untreated decay or any endodontic lesions.
• Patients with thyroid, parathyroid, or renal and liver disease.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

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

Cairo, Cairo Governorate, 11651, Egypt

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dr. Ramadan Yusuf Abu-Shahba Y Dr. Ramadan Yusuf Abu-Shahba, PhD

  rmadanyusf@azhar.edu.eg

  STUDY DIRECTOR

Central Study Contacts

Mahmoud Elsaid Elsayed E Mahmoud Elsaid, BDS

CONTACT

+201003221008; mahmoud_elsaid@azhar.edu.eg

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

CONTACT

+201222993381; MahmoudFathy.209@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Student in Orthodontics

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: March 6, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)