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

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.

Conditions

• Pain Perception
• Root Resorption
• Rate of Orthodontic Tooth Movement
• Biomarkers

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 concentration will be 60 mg in 0.4 ml, and the produced volume will be divided by six lower anterior teeth; each tooth will receive 0.07 ml (10 mg) of the vitamin E.

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.

Sponsors & Collaborators

• University of Baghdad

  lead OTHER

Principal Investigators

• Professor Dr. Yassir Abdulkadhim Yassir, Ph.D. (Orthodontics) (UK) · University of Baghdad

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-23

Primary Completion

2026-02-28

Completion

2026-02-28

Countries

• Iraq

Study Locations