Anterior Teeth Alignment EfficiencyNCT06653881
Comparison of Conventional and Cu-NiTi Archwires Regarding Clinical Efficiency and Pain Intensity Using Prostaglandin E2 Biomarker During Alignment and Leveling
A study testing ARCHWIRE in people with Anterior Teeth Alignment Efficiency and Pain Perception, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Teeth Alignment Efficiency, Pain Perception, PGE2 Biomarker and Their Correlation
- What is being tested?
- ARCHWIRE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 14 Jun 2024to 14 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Title: 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" Rationale:An initial archwire should be effective in aligning the arches while resulting in minimal pain and root resorption. An ideal aligning archwire should have good formability, spring back, stiffness biocompatibility, low friction, and joinability and of low cost. Orthodontic force when exerted on teeth, activates the sensory receptors in periodontal tissues and results in a nociceptive impulse processing in both the central and peripheral nervous systems. A cascade of self-limiting inflammatory reactions including cellular, vascular, neural, and immunological reactions comes into act. In particular, the locally released prostaglandin binds to the periodontal sensory endings which generates a painful sensation resulting in orthodontic pain and tooth movement. PGE2, a cyclooxygenase product, is the best-known lipid mediator that contributes to pain. Thus, the evaluation of PGE2 concentration in GCF would provide an accurate and site-specific insight on objective pain. Furthermore, the VAS score will provide knowledge of the subjective pain perceived by the patients during the initial arch- wire placement.
Therefore, it is important to assess the time point at which the patient undergoing fixed orthodontic treatment will have the maximum pain and therefore in requirement of an analgesic. This is of particular concern during the initiation of treatment since the pain would be compounded with the natural anxiety associated with the orthodontic treatment.
Aims and Objectives: To determine and compare the alignment efficiency and pain perception of 0.016" A-NiTi vs 0.016" Cu-NiTi over 12 weeks period.
Setting: Department of Orthodontics and DentofacialOrthopaedics, PGIDS, Rohtak Study Design:Two-arm parallel single-blind randomized clinical trial. Time frame: 12 weeks after initial archwire placement.
Population/participant:
Inclusion criteria:-Orthodontic patients to be treated with fixed orthodontic treatment requiring non-extraction treatment plan, moderate crowding between 4-6mm in the mandibular anterior region, between 18 and 25 years of age with full complement of teeth erupted to the occlusal level (excluding third molars)optimal periodontal condition and good oral hygiene.
Exclusion Criteria:- craniofacial anomalies and syndromes, congenitally missing teeth (excluding third molars) or severe facial asymmetries ,any systemic disease affecting bone and general growth ,acute or chronic medical patients that are under medications and would affect tooth movement, known allergy to metal and components used in orthodontic treatment.
Sample size:The sample size for the proposed study was calculated by using the formula. Total sample size = N = 2σ2(Zβ+ Zα/2) 2 / (difference)2. A sample size of 13 patients was calculated by using the above formula at confidence interval 95% with power 80%. Accounting for a 10% drop out rate, 15 patients will be enrolled in each group.
Method of study: Pre- treatment records will be taken will be selected from patients reporting to the Department of Orthodontics and Dentofacial Orthopedics, PGIDS, Rohtak. Subjects satisfying inclusion criteria will be divided into two groups.
Group 1 (G1) 0.016"A-NiTi - In this group, 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. 0.016"A-NiTi initial archwire will be securely ligated with elastomeric modules.
Group 2 (G2) 0.016" Cu-NiTi-In this group, 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. 0.016" Cu-NiTi archwire will be securely ligated with elastomeric modules.
Outcome Measures: Changes in the following parameters -little's irregularity index will be measured by model scanning in both the groups. Assessment of these parameters will be done at T0 (baseline data), T1(6 weeks after initial archwire placement), T2(12 weeks after initial archwire placement). Gingival crevicular fluid (GCF) will be collected 1 hr before bonding in lower arch , 24 hours after initial arch wire placement , 48 hrs after initial arch wire placement , 72hrs after initial arch wire placement for assessing PGE2 levels. Pain assessment will be done at 24 hours after initial archwire placement, 48 hours after initial archwire placement, 72 hours after initial archwire placement.
Statistical Analysis: Descriptive statistics and inferential statistics will be used. Data will be checked for normality. In all the analysis, the level of significance will be set at 5 percent.
- Conditions
- Anterior Teeth Alignment Efficiency, Pain Perception, PGE2 Biomarker and Their Correlation
- Being tested
- ARCHWIRE
- Keywords
- TEETH ALIGNMENT, PGE2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARCHWIREOther
Alignment efficiency of the archwires will be compared using little's irregularity index between the two groups
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Other: ARCHWIRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Participants were asked to record the maximum pain experienced each day. The VAS recording sheet, containing three separate scales (one per day), was provided at the time of bonding. Standardized oral hygiene instructions were given to all participants to mark the point on the line corresponding to their maximum daily pain, where 0 indicated "no pain" 5 moderate pain and 10 indicated "severe pain." To promote adherence, daily reminders were sent via phone call or text message. Completed recording sheets were collected at the subsequent follow-up visit.
Measured: 1. 24 hours after initial archwire placement. 2. 48 hours after initial arch wire placement 2. 72 hours after initial arch wire placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start14 Jun 2024
- Primary completion5 Sep 2025
- Study completion14 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Teeth Alignment EfficiencyStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653881
- Sponsor's protocol ID
- RAGHAVI V
- Status last verified
- Feb 2026
- First submitted
- 8 Jun 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional and Cu-NiTi Archwires Regarding Clinical Efficiency and Pain Intensity Using Prostaglandin E2 Biomarker During Alignment and Leveling
- ClinicalTrials.gov ID
- NCT06653881
- Acronym / sponsor ID
- RAGHAVI V
- Conditions
- Anterior Teeth Alignment Efficiency, Pain Perception, PGE2 Biomarker and Their Correlation
- Keywords
- TEETH ALIGNMENT, PGE2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 14 Sep 2025 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Title: 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" Rationale:An initial archwire should be effective in aligning the arches while resulting in minimal pain and root resorption. An ideal aligning archwire should have good formability, spring back, stiffness biocompatibility, low friction, and joinability and of low cost. Orthodontic force when exerted on teeth, activates the sensory receptors in periodontal tissues and results in a nociceptive impulse processing in both the central and peripheral nervous systems. A cascade of self-limiting inflammatory reactions including cellular, vascular, neural, and immunological reactions comes into act. In particular, the locally released prostaglandin binds to the periodontal sensory endings which generates a painful sensation resulting in orthodontic pain and tooth movement. PGE2, a cyclooxygenase product, is the best-known lipid mediator that contributes to pain. Thus, the evaluation of PGE2 concentration in GCF would provide an accurate and site-specific insight on objective pain. Furthermore, the VAS score will provide knowledge of the subjective pain perceived by the patients during the initial arch- wire placement.
Therefore, it is important to assess the time point at which the patient undergoing fixed orthodontic treatment will have the maximum pain and therefore in requirement of an analgesic. This is of particular concern during the initiation of treatment since the pain would be compounded with the natural anxiety associated with the orthodontic treatment.
Aims and Objectives: To determine and compare the alignment efficiency and pain perception of 0.016" A-NiTi vs 0.016" Cu-NiTi over 12 weeks period.
Setting: Department of Orthodontics and DentofacialOrthopaedics, PGIDS, Rohtak Study Design:Two-arm parallel single-blind randomized clinical trial. Time frame: 12 weeks after initial archwire placement.
Population/participant:
Inclusion criteria:-Orthodontic patients to be treated with fixed orthodontic treatment requiring non-extraction treatment plan, moderate crowding between 4-6mm in the mandibular anterior region, between 18 and 25 years of age with full complement of teeth erupted to the occlusal level (excluding third molars)optimal periodontal condition and good oral hygiene.
Exclusion Criteria:- craniofacial anomalies and syndromes, congenitally missing teeth (excluding third molars) or severe facial asymmetries ,any systemic disease affecting bone and general growth ,acute or chronic medical patients that are under medications and would affect tooth movement, known allergy to metal and components used in orthodontic treatment.
Sample size:The sample size for the proposed study was calculated by using the formula. Total sample size = N = 2σ2(Zβ+ Zα/2) 2 / (difference)2. A sample size of 13 patients was calculated by using the above formula at confidence interval 95% with power 80%. Accounting for a 10% drop out rate, 15 patients will be enrolled in each group.
Method of study: Pre- treatment records will be taken will be selected from patients reporting to the Department of Orthodontics and Dentofacial Orthopedics, PGIDS, Rohtak. Subjects satisfying inclusion criteria will be divided into two groups.
Group 1 (G1) 0.016"A-NiTi - In this group, 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. 0.016"A-NiTi initial archwire will be securely ligated with elastomeric modules.
Group 2 (G2) 0.016" Cu-NiTi-In this group, 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. 0.016" Cu-NiTi archwire will be securely ligated with elastomeric modules.
Outcome Measures: Changes in the following parameters -little's irregularity index will be measured by model scanning in both the groups. Assessment of these parameters will be done at T0 (baseline data), T1(6 weeks after initial archwire placement), T2(12 weeks after initial archwire placement). Gingival crevicular fluid (GCF) will be collected 1 hr before bonding in lower arch , 24 hours after initial arch wire placement , 48 hrs after initial arch wire placement , 72hrs after initial arch wire placement for assessing PGE2 levels. Pain assessment will be done at 24 hours after initial archwire placement, 48 hours after initial archwire placement, 72 hours after initial archwire placement.
Statistical Analysis: Descriptive statistics and inferential statistics will be used. Data will be checked for normality. In all the analysis, the level of significance will be set at 5 percent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1: Patient receiving 0.016" A-NiTi (Conventional)archwire. | Experimental | Other: ARCHWIREPretreament 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 . |
| GROUP 2:Patient receiving 0.016" Cu-NiTi archwire. | Experimental | Other: ARCHWIRE. 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARCHWIREAlignment efficiency of the archwires will be compared using little's irregularity index between the two groups | Other | GROUP 1: Patient receiving 0.016" A-NiTi (Conventional)archwire., GROUP 2:Patient receiving 0.016" Cu-NiTi archwire. |
Primary outcome
ARCH ALIGNMENT
Time frame: T0 - Baseline records, at the time before treatment T1 - Records at 6th week after wire placement T2 - Records at 12th week after wire placement
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
1 secondary outcome
SUBJECTIVE PAIN ASSESSMENT BY VISUAL ANALOG SCALE
Time frame: 1. 24 hours after initial archwire placement. 2. 48 hours after initial arch wire placement 2. 72 hours after initial arch wire placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Anterior Teeth Alignment Efficiency
Enrolling by invitation
Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
Crowding of Anterior Mandibular Teeth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARCHWIRE in people with Anterior Teeth Alignment Efficiency and Pain Perception, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ARCH ALIGNMENT (time frame: T0 - Baseline records, at the time before treatment T1 - Records at 6th week after wire placement T2 - Records at 12th week after wire placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.