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
|
|
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
|
|
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. |