| CTRI Number |
CTRI/2025/04/085732 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of various orthodontic wires to correct irregular teeth |
|
Scientific Title of Study
|
Investigating and comparing the effectiveness of various orthodontic aligning archwire materials for initial alignment to alleviate crowding: A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rutvi Menpara |
| Designation |
Post graduate Resident |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
No. 6, PG Division, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Science, Dharmsinh Desai University, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
7016029004 |
| Fax |
|
| Email |
rutvimenpara0811@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aakash Shah |
| Designation |
Professor, HOD, PG and PhD. Guide |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
No. 6, PG Division, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Science, Dharmsinh Desai University, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9825373777 |
| Fax |
|
| Email |
aakash1172@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rutvi Menpara |
| Designation |
Post Graduate Resident |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
No. 6, PG Division, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Science, Dharmsinh Desai University, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
7016029004 |
| Fax |
|
| Email |
rutvimenpara0811@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Science, Dharmsinh Desai University, Nadiad, Gujarat, India, Pin code = 387001 |
|
|
Primary Sponsor
|
| Name |
Rutvi Menpara |
| Address |
No. 6, PG Division, Department of Orthodontics and Dentofacial Orthopedics Faculty of Dental Science, Dharmsinh Desai University, Nadiad, Gujarat, Pincode 387001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rutvi Menpara |
Faculty of Dental Science, Dharmsinh Desai University |
No.6, PG Division, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Science, Dharmsinh Desai University
Kheda
GUJARAT |
7016029004
rutvimenpara0811@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Faculty of Dental Science, Dharmsinh Desai University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison the effectiveness of four archwire materials namely HANT, SENT, CuNiTi and Multistranded SS to alleviate crowding |
The mandibular anterior segment will be evaluated in this study. Baseline records will be obtained through alginate impressions. Subsequently, Lower arch bonding will be done using a MBT bracket prescription of slot size 0.022 x 0.028" (3M Gemini TM). Every case will be determined according to present malocclusion . Following bonding, archwires of varying dimensions (0.014", 0.016", 0.018", and 0.020"). Archwires will be sequentially replaced at 30-day intervals. Alginate impressions will be recorded at each follow-up appointment to document changes over time. |
| Comparator Agent |
Conventional bonding with CuNiTi archwires of the following dimensions : 0.014", 0.016", 0.018", 0.020". |
The mandibular anterior segment will be evaluated using Littles irregularity index. Initial records will be obtained through alginate impressions. Bonding will be performed with MBT bracket prescription of slot size 0.022 x 0.028" (3M Gemini TM). Positioning will be determined according to the malocclusion present. After bonding, Copper NiTi (CuNiTi) archwires will be introduced sequentially in sizes 0.014", 0.016", 0.018", and 0.020", with each wire being replaced at 30-day intervals. Alginate impressions will be taken at each follow-up visit to document the progressive changes brought about by the archwires. |
| Comparator Agent |
Conventional bonding with heat Activated NiTi archwires of the following dimensions : 0.014", 0.016", 0.018", 0.020". |
The mandibular anterior segment will be assessed using Littles irregularity index. Baseline records will be obtained through alginate impressions. Bonding will be done using MBT bracket prescription of slot size 0.022 x 0.028" (3M Gemini TM) according to the malocclusion present. After bonding, Heat-Activated NiTi archwires will be placed sequentially in sizes 0.014", 0.016", 0.018", and 0.020", with each wire being replaced at 30-day intervals. Alginate impressions will be recorded at each follow-up visit to monitor the progressive changes facilitated by the wire. |
| Comparator Agent |
Conventional bonding with Multistranded stainless steel archwires of the following dimensions : 0.0155", 0.0175", 0.0195". |
The mandibular anterior segment will be analyzed using Littles irregularity index. Initial records will be obtained through alginate impressions. Bonding will be performed with MBT bracket prescription of slot size 0.022 x 0.028" (3M Gemini TM). Positioning will be determined according to the malocclusion present. Following the bonding procedure, multistranded stainless steel archwires of dimensions 0.0155", 0.0175", and 0.0195" will be placed in succession, with each wire being replaced at 30-day intervals. Alginate impressions will be recorded at each follow-up session to document the progressive changes over time. |
| Comparator Agent |
Conventional bonding with Superelastic NiTi archwires of the following dimensions : 0.014", 0.016", 0.018", 0.020". |
The mandibular anterior segment will be evaluated using Littles irregularity index. Initial records will be obtained through alginate impressions. Bonding will be performed with MBT bracket prescription of slot size 0.022 x 0.028" (3M Gemini TM). Positioning will be determined according to the malocclusion present. Following bonding, a Superelastic NiTi archwire will be placed sequentially, progressing through sizes 0.014", 0.016", 0.018", and 0.020", with each wire being changed at 30-day intervals. Alginate impressions will be recorded at each follow-up appointment to assess the progressive changes induced by each wire. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time required to alleviate crowding |
1 month
2 months
3 months
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain perception of patient |
recorded for 7 days after changing the archwire every 30 days |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |