A Phase 1 interventional study of 1: Vitamin C Supplementation and Vitamin E Supplementation in Pain Perception, Root Resorption and Rate of Orthodontic Tooth Movement, sponsored by University of Baghdad. Completed at 3 sites in Iraq. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Baghdad · Phase 1, Interventional, and Treatment
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:
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.
This randomized clinical trial aims to investigate the effects of locally administered vitamins C and E on mandibular incisor crowding relief during the initial stage of orthodontic treatment. The study follows a multicenter, prospective, single-blind, parallel-group design with equal randomization (1:1:1) and is conducted at Bab Al-Muadham Dental Health Center and the Postgraduate Orthodontic Clinic, Department of Orthodontics, College of Dentistry, University of Baghdad. Participants were blinded to group allocation, while the principal investigator (A.M.H.) was aware of all group allocations throughout the study period.
Study Rationale Orthodontic tooth movement involves a complex biological process mediated by bone remodeling, which is regulated by mechanical forces and biochemical mediators. Oxidative stress and inflammatory responses play a significant role in the remodeling process. Vitamin C (ascorbic acid) and vitamin E (tocopherol) are known for their antioxidant properties and potential effects on bone metabolism, tissue healing, and inflammation modulation. This study aims to determine whether locally administered vitamins C and E can enhance orthodontic tooth movement, reduce adverse effects such as root resorption, and improve patient experience during treatment.
Study Objectives The primary objective is to compare the effectiveness of vitamin C and vitamin E injections versus a saline control in mandibular incisor crowding relief over 24 weeks.
The secondary objectives include:
Assessing the extent of apical root resorption using periapical radiographs. Evaluating pain perception using a 0-10 numerical rating scale (NRS) during the first seven days after each archwire placement.
Measuring patient perception of treatment experience through a structured questionnaire.
Analyzing levels of biomarkers associated with bone remodeling (RANKL, OPG, RUNX2) in gingival crevicular fluid (GCF) to determine the biological effects of the interventions.
Participant Selection Eligible participants are patients aged 12 years and older with moderate to very severe mandibular anterior crowding (Little's Irregularity Index [LII]). Exclusion criteria include systemic diseases, prior orthodontic treatment, or the use of medications that could influence bone metabolism or inflammatory responses.
Intervention Groups
Participants will be randomly assigned to one of three groups:
Control Group: Receives 0.6 mL of normal saline, divided among the six mandibular anterior teeth and administered every two weeks.
Vitamin C Group: Receives intraepidermal injection of vitamin C (120 mg in 1.2 mL, divided among six mandibular anterior teeth).
Vitamin E Group: Receives intraepidermal injection of vitamin E (15 mg in 0.1 mL, divided among six mandibular anterior teeth).
Injections are repeated biweekly for the vitamin C and control groups and monthly for the vitamin E group, for a total of six months (24 weeks).
A pilot phase included 10 participants. Four participants who received the initial vitamin E regimen of 60 mg in 0.4 mL every two weeks were excluded from the final analysis after the regimen was modified because of poor absorption of the oil-based formulation. The final vitamin E regimen was reduced to 15 mg in 0.1 mL and administered once monthly. The remaining participants in the vitamin C and control groups continued in the trial and were included in the final analysis.
Orthodontic Treatment Protocol
All participants undergo standardized orthodontic treatment using MBT brackets (0.022-inch slot). The leveling and alignment phase follows a sequential archwire progression with CuNiTi archwires in the following sequence:
0.014-inch CuNiTi (weeks 0-8) 0.016-inch CuNiTi (weeks 8-16) 0.018-inch CuNiTi (weeks 16-24)
Data Collection and Outcome Assessments
Data will be collected at multiple time points throughout the study:
Statistical Analysis
Data will be analyzed using SPSS version 26. Statistical methods will include:
Descriptive statistics (mean, standard deviation, frequency). Intraclass correlation coefficients and weighted kappa statistics for measurement reliability.
One-way analysis of variance, mixed-design repeated-measures analysis of variance, Kruskal-Wallis test, Wilcoxon signed-rank test, Pearson's chi-square test, and Friedman test.
A significance level of 0.05 will be used for hypothesis testing, with Bonferroni adjustment where applicable.
Study Oversight and Ethical Considerations The study is self-funded and complies with ethical guidelines for human research. Ethical approval was obtained from the Research Ethics Committee of the College of Dentistry, University of Baghdad, on 21 January 2025 (reference number 1014; project number 1014425). Written informed consent was obtained from adult participants. For participants younger than 18 years, written parental or guardian consent and participant assent were obtained before enrolment.
Potential Impact This trial may provide valuable insights into the role of antioxidant therapy in orthodontic treatment. If vitamins C and E positively influence tooth movement and root integrity, their use could enhance treatment efficiency while minimizing complications. Findings may also contribute to a better understanding of bone remodeling mechanisms in response to mechanical forces.
43 studies on the registry are indexed under Root Resorption; 9 are open to participants now.
This study's enrollment of 56 is above the median of 29 across 36 interventional studies indexed under Root Resorption.
Browse Root Resorption studies →University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.
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5. The overbite and overjet should not impede bracket placement on the mandibular anterior teeth.
Exclusion Criteria:
This arm involves participants receiving Vitamin C to assess its effect on orthodontic tooth movement and crowding relief. The treatment aims to evaluate how Vitamin C influences the rate of tooth movement, as measured by Little's Irregularity Index (LII) over 24 weeks (the supposed end date of leveling and alignment stage).
Drug: 1: Vitamin C Supplementation
Participants in this arm will receive Vitamin E to evaluate its effect on orthodontic tooth movement. The aim is to compare the efficacy of Vitamin E to Vitamin C and the saline control in terms of crowding relief and tooth alignment, measured using LII over a 24-week period (the supposed end date of leveling and alignment stage).
Drug: Vitamin E Supplementation
This arm serves as the control group, where participants receive saline injections. The primary aim is to assess how saline compares with Vitamin C and Vitamin E treatments in terms of the rate of orthodontic tooth movement and crowding relief as measured by LII.
Other: Saline Solution (Control)
• 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.
• 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.
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.
Difference in the amount of crowding relief of the mandibular incisors before treatment and at 4, 8, 12, 16, 20, and 24 weeks after the start of treatment among the two vitamins and control groups
The amount of crowding relief will be measured using Little's Irregularity Index (LII) on 3D digital models of the mandibular anterior teeth. Pre-treatment (T0) and post-treatment models at 4, 8, 12, 16, 20, and 24 weeks will be compared. * Measurement method: Alginate impressions will be taken at each time point and converted into 3D digital models using a high-precision scanner. * Definition: LII quantifies anterior misalignment by summing the displacement between mesial and distal contact points of six mandibular incisors. * Units: Millimeters (mm), rounded to 0.01 mm. * Expected outcome: Greater LII reduction indicates a higher rate of tooth movement. * Comparison: The control (saline) group will be compared with the vitamin C and vitamin E groups to assess their effects on tooth movement.
Time frame: The amount of crowding relief will be measured using Little's Irregularity Index (LII) on 3D digital models of the mandibular anterior teeth. Measurements will be taken at baseline (T0) and at 4, 8, 12, 16, 20, and 24 weeks to assess changes over time.
Pain Perception After Archwire Placement: A Visual Analog Scale Assessment
Pain perception will be measured using a Visual Analog Scale (VAS), a commonly used tool in clinical settings to quantify subjective pain experiences. The VAS consists of a 10 cm line where participants mark their pain level. One end of the line represents "no pain" (score of 0), and the other end represents "worst pain imaginable" (score of 10). Participants will be asked to record their pain levels twice daily for the first 7 days following each archwire placement during the treatment phase.
Time frame: From the placement of each archwire to 7 days post-placement.
Amount of orthodontically-induced inflammatory root resorption (OIIRR) in the apical region of mandibular anterior teeth
Measurement of the root resorption in the apical region of the mandibular anterior teeth, assessed through radiographs and calculated by comparing the root length and crown length.
Time frame: Pre-treatment (T0), 8 weeks (T1), and 24 weeks (T2) after the start of treatment.
Patient perception using a newly developed questionnaire for adjunctive orthodontic therapy
Patients will complete a questionnaire to assess their perception of the treatment's comfort, side effects, and any additional effects due to vitamin administration during orthodontic therapy.
Time frame: 8 weeks after the start of treatment.
Levels of biomarkers (RANKL, OPG, and RUNX2) in gingival crevicular fluid (GCF):
Measurement of the biomarkers in the GCF, which are involved in bone turnover and remodeling. These markers will help assess the biological effects of the vitamins on periodontal tissues during the initial stage of orthodontic treatment.
Time frame: Pre-treatment (T0), 1 week (T1), and 4 weeks (T2) after the start of treatment.
Plan to share: No
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