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COMPLETED
NCT06847880
PHASE1

The Potential Effect of the Local Administration of Vitamins C and E on Orthodontic Treatment: A Randomized Clinical Trial

Sponsor: University of Baghdad

View on ClinicalTrials.gov

Summary

Brief Summary of the Study This study investigates the effects of locally administered vitamins C and E on orthodontic tooth movement during the initial stage of treatment. Orthodontic tooth movement relies on bone remodeling, which can be influenced by antioxidants like vitamins C and E. Vitamin C promotes collagen formation and osteoblast activity, while vitamin E has anti-inflammatory and antioxidant properties that may impact bone metabolism. The study is a randomized clinical trial conducted in multiple clinics, where patients will be divided into three groups: 1. Control group - receives a saline injection. 2. Vitamin C group - receives a local injection of vitamin C. 3. Vitamin E group - receives a local injection of vitamin E. Injections will be administered every two weeks for vitamin C and every month for vitamin E, for six months, while patients undergo orthodontic treatment with fixed appliances. Researchers will evaluate the rate of tooth movement, root resorption, pain perception, and patient experience. Additionally, biomarkers related to bone remodeling will be measured in gingival crevicular fluid at different time points. The study aims to determine whether local administration of vitamins C or E enhances orthodontic tooth movement and elevate their effects on the orthodontic potential side effects like root resorption and pain. The findings may provide valuable insights into optimizing orthodontic treatment with the help of antioxidants.

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-02-27

Completion Date

2026-03-28

Last Updated

2026-09-03

Healthy Volunteers

Yes

Interventions

DRUG

1: Vitamin C Supplementation

• Vitamin C (Ascorbic Acid): This intervention involves the administration of vitamin C, which is known for its antioxidant properties. The concentration will be 120 mg in 1.2 ml, and the produced volume will be divided by six lower anterior teeth; each tooth will receive 0.2 ml (20 mg) of the vitamin C. It is hypothesized to accelerate orthodontic tooth movement by reducing oxidative stress and promoting collagen synthesis.

DRUG

Vitamin E Supplementation

• Vitamin E (Tocopherol Acetate): This intervention uses vitamin E, another antioxidant, thought to reduce inflammation and support tissue repair, potentially improving the effectiveness of orthodontic treatment by enhancing tissue recovery and reducing side effects. The total dose was 15 mg in 0.1 mL, divided among the six mandibular anterior teeth; each tooth received 2.5 mg in approximately 0.02 mL. Vitamin E was administered once monthly for 24 weeks.

OTHER

Saline Solution (Control)

Saline Solution (Control): The control group will receive a saline solution, which is a placebo, allowing for the comparison of the effects of vitamin C and vitamin E on orthodontic tooth movement without the influence of additional nutrients.

Locations (3)

Baghdad Al-Karkh Health Directorate, Baghdad, Iraq

Baghdad, Baghdad Governorate, Iraq

Baghdad Al-Rusafa Health Directorate

Baghdad, Baghdad Governorate, Iraq

College of Dentistry, University of Baghdad, Baghdad, Iraq

Baghdad, Baghdad Governorate, Iraq