A comparison of various orthodontic wires to correct irregular teeth

Phase 3

Not yet recruiting

• Conditions: Other disorders of teeth and supporting structures,

• Registration Number: CTRI/2025/04/085732
• Lead Sponsor: Rutvi Menpara

Brief Summary

**Aim**

This randomized clinical trial aims to investigate and compare the effectiveness of various orthodontic aligning archwire materials—specifically Superelastic NiTi, Heat-Activated NiTi, Copper NiTi (CuNiTi), and Multistranded Stainless Steel—in achieving initial alignment and alleviating dental crowding. The goal is to provide clinically relevant insights into the most efficient archwire materials for early-stage orthodontic treatment.

**Materials and Method**

The study will be conducted at the **Department of Orthodontics and Dentofacial Orthopedics**, **Faculty of Dental Science**, **Dharmsinh Desai University**, **Nadiad**.

A total of four different archwire types will be evaluated:

- Superelastic Nickel-Titanium (0.014", 0.016", 0.018", 0.020")(NiTi)

- Heat-activated nickel-titanium (0.014", 0.016", 0.018", 0.020"(NiTi)

- Copper Nickel-Titanium (0.014", 0.016", 0.018", 0.020"(CuNiTi)

- Multistranded Stainless Steel (0.0155",0.0175",0.0195")

These archwires will be used in varying dimensions based on clinical requirements. The bonding of brackets will be done sequentially, and archwire changes will occur at 30-day intervals.

Alginate impressions will be taken at each follow-up visit to evaluate progressive tooth movement and assess changes in alignment over time. These records will serve as the basis for comparing the alignment efficiency of the different archwire types.

**Statistical Analysis**

Data collected will undergo a thorough statistical evaluation:

- **Normality Assessment**: Shapiro-Wilk test or Kolmogorov-Smirnov test will be used to assess the normality of the data distribution.

- **Group Comparison**:

- If the data are normally distributed, **One-way ANOVA** will be employed.

- If the data are not normally distributed, the **Kruskal-Wallis test** will serve as the non-parametric alternative.

- **Post Hoc Analysis**:

- For ANOVA, **Tukey’s HSD test** will be used.

- For non-parametric comparisons, **Bonferroni correction** will be applied.

The statistical outcomes will help determine which archwire material is most effective in achieving initial alignment in orthodontic patients.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-14
• Study Start: 2025-06-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Patients scheduled for fixed appliance orthodontic treatment who have mild to moderate crowding (3-6 mm) according to LII.
• Complete lower permanent dentition excluding third molars No history of trauma or root resorption.

Exclusion Criteria

• Previous history of undergoing orthodontic treatment Less than 3 mm of lower incisor crowding or spaced incisors Blocked out teeth that cannot be engaged with the aligning archwire.
• Patients with periodontally compromised teeth.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time required to alleviate crowding	1 month | 2 months | 3 months | 4 months

Secondary Outcome Measures

Name	Time	Method
Pain perception of patient	recorded for 7 days after changing the archwire every 30 days

Trial Locations

Locations (1)

Faculty of Dental Science, Dharmsinh Desai University; 🇮🇳 Kheda, GUJARAT, India

Faculty of Dental Science, Dharmsinh Desai University

🇮🇳Kheda, GUJARAT, India

Dr Rutvi Menpara

Principal investigator

7016029004

rutvimenpara0811@yahoo.in