Comparing two types of archwires for orthodontic treatment efficiency and pain levels
Comparison of Conventional and Cu-NiTi Archwires Regarding Clinical Efficiency and Pain Intensity Using Prostaglandin E2 Biomarker During Alignment and Levelling: a Randomized Clinical Trial
This study is testing whether conventional or Cu-NiTi archwires cause less pain and work better for young adults getting braces.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 25 Years |
| Sex | All |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak Academic / other |
| Locations | 1 site (Rohtak, Haryana) |
| Trial ID | NCT06653881 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and pain intensity associated with conventional and Cu-NiTi archwires during orthodontic treatment. It focuses on measuring the levels of prostaglandin E2 (PGE2) in gingival crevicular fluid as a biomarker for inflammation and pain. The study involves orthodontic patients aged 18 to 25 who require fixed non-extraction treatment and assesses both objective and subjective pain responses during the initial archwire placement. The goal is to determine which archwire type provides better alignment efficiency with minimal discomfort.
Who should consider this trial
Good fit: Ideal candidates are orthodontic patients aged 18 to 25 with moderate crowding in the mandibular anterior region and no history of previous orthodontic treatment.
Not a fit: Patients with acute or chronic medical conditions, craniofacial anomalies, or those who have undergone previous orthodontic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved orthodontic treatment experiences by minimizing pain and enhancing alignment efficiency.
How similar studies have performed: Previous studies have explored the effects of different archwire materials on pain and efficiency, suggesting that this approach has potential based on existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Orthodontic patients to be treated with fixed orthodontic treatment requiring non-extraction treatment plan. * Patients' with pre-treatment moderate crowding between 4-6mm in the mandibular anterior region assessed with Little's Irregularity index. * Male and female patients between 18 and 25 years of age with full complement of teeth erupted to the occlusal level (excluding third molars). * Non syndromic patients and no impaction of teeth except third molars. * No history of previous orthodontic treatment. * Optimal periodontal condition and good oral hygiene. Exclusion Criteria: * Acute or chronic medical patients that are under medications and would affect tooth movement. * Medical conditions that contraindicate orthodontic treatment. * Craniofacial anomalies and syndromes, congenitally missing teeth (excluding third molars) or severe facial asymmetries. * Any systemic disease affecting bone and general growth. * Patients' with known allergy to metal and components used in orthodontic treatment.
Where this trial is running
Rohtak, Haryana
- Pgids — Rohtak, Haryana, India (Recruiting)
Study contacts
- Study coordinator: Dr.Devender kumar
- Email: Davenderkumar0195@gmail.com
- Phone: 8950447738
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.