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CTRI Number  CTRI/2020/03/024175 [Registered on: 23/03/2020] Trial Registered Prospectively
Last Modified On: 21/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial comparing two different Orthodontic arch wires. 
Scientific Title of Study   Comparison of two different initial arch wires for tooth alignment during fixed orthodontic treatment- A clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubhangi jain 
Designation  post graduate student 
Affiliation  ITS dental college, Muradnagar 
Address  Department of Orthodontics and Dentofacial orthopaedics, Room no 8, ITS-CDSR, Muradnagar, Ghaziabad, UP 201206
Department of Orthodontics and Dentofacial orthopaedics, Room no 8, ITS-CDSR, Muradnagar, Ghaziabad, UP 201206
Ghaziabad
UTTAR PRADESH
201206
India 
Phone  9811344831  
Fax    
Email  shubhangi.jain.92@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Payal Sharma 
Designation  Professor and Head 
Affiliation  ITS dental college 
Address  Department of Orthodontics and Dentofacial orthopaedics, Room no 8, ITS-CDSR, Muradnagar, Ghaziabad, UP 201206
Department of Orthodontics and Dentofacial orthopaedics, Room no 8, ITS-CDSR, Muradnagar, Ghaziabad, UP 201206
Ghaziabad
UTTAR PRADESH
201206
India 
Phone  9212708451  
Fax    
Email  payalsharma@its.edu.in  
 
Details of Contact Person
Public Query
 
Name  Shubhangi jain 
Designation  Post graduate student 
Affiliation  ITS dental college 
Address  Department of Orthodontics and Dentofacial orthopaedics, Room no 8, ITS-CDSR, Muradnagar, Ghaziabad, UP 201206
Department of Orthodontics and Dentofacial orthopaedics, Room no 8, ITS-CDSR, Muradnagar, Ghaziabad, UP 201206
Ghaziabad
UTTAR PRADESH
201206
India 
Phone    
Fax    
Email  shubhangi.jain.92@gmail.com  
 
Source of Monetary or Material Support  
Shubhangi Jain, Department of Orthodontics and Dentofacial orthopaedics, Room no 8, ITS-CDSR, Muradnagar, Ghaziabad, UP 201206 
 
Primary Sponsor  
Name  Shubhangi jain 
Address  ITS-CDSR, muradnagar, Ghaziabad, UP-201206 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shubhangi Jain  I.T.S Dental college and research centre  Department of Orthodontics and Dentofacial orthopaedics, Room no 8, ITS-CDSR, Muradnagar, Ghaziabad, UP 201206
Ghaziabad
UTTAR PRADESH 
9811344831

shubhangi.jain.92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ITS institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  irregular teeth 
Patients  (1) ICD-10 Condition: K009||Disorder of tooth development, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.016 Heat activated Niti wire (3M Unitek)  The wire will be placed immediately post bonding. The aligning efficiency, pain and root resorption willl be evaluated. 
Intervention  0.016 superplastic Niti wire (3M Unitek)  The wire will be placed immediately post bonding. The aligning efficiency, pain and root resorption willl be evaluated. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patients requiring fixed orthodontic treatment with extraction of 1st premolars.
Patients with crowding in lower anterior segment having a mandibular irregularity index 5-8.
Patients with no relevant medical history.
no recent history of intake of drugs such as non-steroidal anti-inflammatory drugs.
 
 
ExclusionCriteria 
Details  Patients with systemic diseases, active periodontal disease, spacing in lower anterior region and those who had undergone previously orthodontic treatment  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the aligning efficiency of 0.016 in superplastic Niti and 0.016 Heat activated niti  every 3 weeks till end of completely aligned. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the pain due to 0.016 in superplastic Niti and 0.016 Heat activated niti in aligning phase  24 hrs and 1 week after placement of wire 
To evaluate and compare the root resorption due to 0.016 in superplastic Niti and 0.016 Heat activated niti  before wire placement and post alignment  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 2/ Phase 3 
Date of First Enrollment (India)   24/03/2020 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The aim of the study is to clinically evaluate and compare two different initial aligning arch wires: conventional Ni-Ti and superelastic Ni-Ti in relation to the alignment efficiency, root resorption and pain intensity. The null hypothesis will be that there is no significant difference in the rate of alignment, pain intensity and root resorption during aligning phase using two different initial aligning archwires. The present study will be conducted in the Department of Orthodontics and Dentofacial orthopedics, I.T.S - Centre for Dental studies and research, Muradnagar, Uttar Pradesh, India. Twenty patients requiring fixed orthodontic treatment will be selected to participate in the study according to the following criteria:

Inclusion criteria

 Patients aged 15-25 yrs of age.

 Patients requiring fixed orthodontic treatment with extraction of 1st premolars.

Patients with crowding in lower anterior segment having a mandibular irregularity index  5-8.

Patients with no relevant medical history.

no recent history of intake of drugs such as non steroidal anti inflammatory drugs.

Exclusion criteria

 Subjects with systemic diseases.

 Patients with active periodontal disease

 Patients who have undergone previous active orthodontic treatment.

 Patients with spacing in the lower anterior region.

 Patients with a blocked-out tooth that do not allow for placement of the bracket at the initial bonding appointment.


Methodology: The study will be conducted on 20 patients using two different initial aligning archwires i.e. conventional Ni-Ti  (test group A) and superelastic Ni-Ti wire (test group B) for the alignment of the mandibular arches. All the patients selected for the study will receive MBT prescription with 0.022x0.028 inch slot size.

The rate of alignment will be assessed in the mandibular arch. Good quality alginate impressions will be taken at the pre-alignment phase. After the placement of bonded attachments and bands, the aligning archwire will be placed using elastomeric ligatures. The patient will be recalled every month and a good quality alginate impression will be taken. This procedure will be conducted till archwire does not show any deflection at any site anteriorly regardless of remaining buccal irregularities.

After the placement of initial aligning archwires, the patient will be asked to record the pain and discomfort after 24 hours and 1 week after the placement of the archwire on a visual analogue scale.

In this study pre treatment CBCT radiographs of the patients will be taken to determine the root length of mandibular anterior teeth. After the completion of the aligning phase of the treatment, a post-alignment CBCT will be done to assess the root resorption during the aligning phase.

 

The data will be tabulated and sent for statistical analysis. 

 

 
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