Comparison of Conventional and Cu-NiTi Archwires Regarding Clinical Efficiency and Pain Intensity Using Prostaglandin E2 Biomarker During Alignment and Leveling

NCT06653881 | Completed

• 1 other identifier: RAGHAVI V
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Orthodontic treatment can inflame the periodontium and dental pulp, it can be uncomfortable and even painful at times. This may induce discomfort and the release of different biochemical mediators, which is one of the main causes of apprehension and the thing people detest the most before getting orthodontic treatment\[1\]. The gingival crevicular fluid (GCF), which surrounds the teeth, may exhibit particular chemical levels that indicate an inflammatory reaction that may occur throughout the orthodontic treatment procedureThe inflammatory response that arises during orthodontic treatment is mediated mostly by prostaglandin E2 (PGE2). Bone resorption may result from PGE2's activation of osteoclastic cells and increases vascular dilatation and permeability.Both rats and humans showed increased tooth movement when local prostaglandins were administered subperiosteally injected..Osteoclastic activity occurs on the pressure side of a tooth in response to an external stimulus. Simultaneously, the growth and maturation of mesenchymal stem cells (MSCs) and periodontal ligament (PDL) fibroblasts promote greater bone formation by osteoblasts on the tension side. Additionally, in osteoblasts, mechanical stress rapidly starts several cellsignalingpathways, such as those for calcium (Ca2+), nitric oxide (NO), interleukin-1 (IL-1), and adenosine triphosphate (ATP).PGE2 secretion, ATP release, and osteoblast growth are all caused by fluid shear stress activating the Ca2+ signaling pathway. The PDL experiences reduced blood flow and hypoxia at the same time on the compression side. As a result of the transcription factor HIF-1, PDL fibroblasts, and osteoblasts express VEGF and RANK-L, which stimulates osteoclast development and bone resorption in compression zones. As orthodontic movement occurs, this link becomes apparent when the alveolar bone around the tooth's root is remodelled\[2\]. Pain is a common side effect of orthodontic therapy, which can be very concerning to patients. Up to 72 to 100% of patients report feeling some degree of discomfort during orthodontic treatment, suggesting that many people believe the procedure to be quite painful. Unfortunately, this dread of discomfort might keep some people from ever pursuing orthodontic treatment, and it can even lead to others stopping their treatment after it has begun. Orthodontic discomfort can be effectively measured with the visual analog scale; however, its subjective character may have certain limitations. To select the most appropriate and successful type of archwires, the orthodontist must be aware of the distinctive qualities of each kind that is offered. The prevalence of stainless-steel wires for first alignment has declined with the development of nickel-titanium (NiTi) archwires.A material that can be produced stably to stop phase transition is nickel-titanium (NiTi) alloy. Additionally, it can exist in an active form with two different crystalline or lattice structures, called the austenitic (A) and martensitic (M) forms, each having specific mechanical and physical properties. The application of stress or a temperature change can cause the wire to transition between these two phases, changing its properties without compromising its structural integrity\[4\]. Wires have a remarkable phenomenon known as superelasticity, which is also called plateau behavior. These wires are very useful, especially for initial aligning archwires, because they can exert constant forces regardless of the degree of bending. The transition temperature, which may be predicted during the production process, is the temperature at which an alloy changes from one phase to another. Compared to other archwires, the A-NiTi archwire has exceptional spring-back characteristics. It is usual practice to add copper (Cu) to nickel-titanium (NiTi) alloy. The purpose of this adjustment is to lessen loading stress and offer the ideal force for efficient orthodontic tooth movement. Based on its phase transition and temperature dependency, the Cu-NiTi archwire displays thermo-elastic characteristics. In best of my knowledge there is no any study who had compared the effect of two wires using PGE2 levels at different intervals in levelling and alignment. This study will compare the clinical outcomes of orthodontic treatment using NiTi against Cu-NiTi archwires in terms of tooth alignment rate and pain threshold by PGE2 biomarker.

Conditions

Pain Perception; PGE2 Biomarker and Their Correlation; Anterior Teeth Alignment Efficiency

Keywords

TEETH ALIGNMENT; PGE2

Outcome Measures

Primary Outcomes (1)

• ARCH ALIGNMENT

  Alginate impression(Algitex impression material,Dental products of India) were taken and models were poured immediately using dental gypsum type III orthokal material(Kalabhai,karson,India) Later cast were scanned using three dimensional intra oral scanner (iTero Element Flex Portable Intraoral Scanner) \& STL files were obtained. STL files were imported into the Geomagic Freeform software v2022.0.34 (3D Systems, Rockhil,Sc) )\& was used to digitally calculate the measurements for alignment efficiency . THREE-DIMENSIONALSUPERIMPOSITION ANALYSIS by using a 3D software program (Geomagic Freeform software v2022.0.34). The amount of alignment achieved during the study using each different archwire was measured in all three dimensions. Arizona).For precise measurement, three anatomical reference points were identified - meiolabioincisal point ,midpoint on the cusp tip/incisal edge ,distolabioincisal point were taken on each tooth \& average was calculated

  T0 - Baseline records, at the time before treatment T1 - Records at 6th week after wire placement T2 - Records at 12th week after wire placement

Secondary Outcomes (1)

• SUBJECTIVE PAIN ASSESSMENT BY VISUAL ANALOG SCALE

  1. 24 hours after initial archwire placement. 2. 48 hours after initial arch wire placement 2. 72 hours after initial arch wire placement

Other Outcomes (1)

• GCF COLLECTION

  1. 1 hour before bonding in lower arch 2. 24 hours after initial arch wire placement 2. 48 hours after initial arch wire placement 2. 72 hours after initial arch wire placement

Study Arms (2)

GROUP 1: Patient receiving 0.016" A-NiTi (Conventional)archwire.

EXPERIMENTAL

Pretreament orthodontic records (T0) of all the patients undergoing study will be taken before bonding. Before bonding, teeth will be isolated and oral prophylaxis will be performed. Enamel will be etched with 37% phosphoric acid gel, rinsed with water and air dried till a frosty appearance of the etched surface was evident. Bonding agent will be applied and cured using LED curing light unit. A conventional orthodontic adhesive will be used to bond brackets with 0.022 ̎×0.028 inch slot. In this group ,1 0.016"A-NiTi initial archwire will be securely ligated .

Other: ARCHWIRE

GROUP 2:Patient receiving 0.016" Cu-NiTi archwire.

EXPERIMENTAL

. Pretreament orthodontic records (T0) of all the patients undergoing study will be taken before bonding. Before bonding, teeth will be isolated and oral prophylaxis will be performed. Enamel will be etched with 37% phosphoric acid gel, rinsed with water and air dried till a frosty appearance of the etched surface was evident. Bonding agent will be applied and cured using LED curing light unit. A conventional orthodontic adhesive will be used to bond brackets with 0.022 ̎×0.028 inch slot. In this group 0.016" Cu-NiTi archwire will be securely ligated.

Other: ARCHWIRE

Interventions

ARCHWIRE OTHER

Alignment efficiency of the archwires will be compared using little's irregularity index between the two groups

GROUP 1: Patient receiving 0.016" A-NiTi (Conventional)archwire.; GROUP 2:Patient receiving 0.016" Cu-NiTi archwire.

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: October 22, 2024
• Study Start: June 14, 2024
• Primary Completion: September 5, 2025
• Study Completion: September 14, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)