| CTRI Number |
CTRI/2021/02/031065 [Registered on: 08/02/2021] Trial Registered Prospectively |
| Last Modified On: |
07/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Clinical evaluation of the alignment efficacy and pain with CuNiTi and Multistranded SS arch wires during initial orthodontic treatment- Randomised clinical trial.
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Scientific Title of Study
|
Clinical evaluation of the alignment efficacy and pain with CuNiTi and Multistranded SS arch wires during initial orthodontic treatment- Randomised clinical trial.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
obili Sobitha |
| Designation |
Post graduate student |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of orthodontics and dentofacial orthopaedics, Narayana dental college and hospital, chintareddypalem, Nellore. Andhra pradesh.
Rohini girls hostel, Narayana dental college and hospital, chintareddypalem, Nellore. Andhra pradesh.
Nellore
ANDHRA PRADESH
524004
India |
| Phone |
8328009575 |
| Fax |
|
| Email |
reddyshobitha489@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Mandava prasad |
| Designation |
Professor and head of the department, orthodontics and dentofacial orthopaedics |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of orthodontics and dentofacial orthopaedics, room number : 6, Narayana dental college and hospital, chintareddypalem, Nellore. Andhra pradesh.
Nellore
ANDHRA PRADESH
524004
India |
| Phone |
9440976666 |
| Fax |
|
| Email |
mandavabruno9@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
S Gowri sankar |
| Designation |
professor, department of orthodontics and dentofacial orthopaedics |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of orthodontics and dentofacial orthopaedics, room number: 6. Narayana dental college and hospital, chintareddypalem, Nellore. Andhra pradesh.
Nellore
ANDHRA PRADESH
524004
India |
| Phone |
9440012443 |
| Fax |
|
| Email |
drgowrisankar@gmail.com |
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Source of Monetary or Material Support
|
| O.Sobitha
Department of orthodontics,Narayana dental college and hospital, Chintareddypalem, Nellore, Andhra pradesh. |
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Primary Sponsor
|
| Name |
O Sobitha |
| Address |
Department of orthodontics and dentofacial orthopaedic s, room number: 6, Narayana dental college and hospital, Chintareddypalem, Nellore, Andhra pradesh. 524004 |
| Type of Sponsor |
Other [Self] |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Obili Sobitha |
Narayana dental college and hospital |
Department of orthodontics, Room number :6, Narayana dental college and hospital, Chintareddypalem, Nellore, Andhra pradesh. 524004
Nellore
ANDHRA PRADESH |
8328009575
reddyshobitha489@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee of Narayana dental college and hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K006||Disturbances in tooth eruption, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.016inch Cu NiTi archwire |
Copper nickel titanium wire used for decrowding of lower anterior teeth in the initial aligning and leveling phase. |
| Comparator Agent |
0.0175 inch Multistranded SS archwire |
Multistranded SS wire used for decrowding of lower anterior teeth in the initial aligning and leveling phase. |
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Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of normal health with physical and mental fitness.
2. Age between 12 to 20 years
3. Patients with symmetrical jaws as assessed on orthopantamogram (OPG).
4. Confirmation that all permanent teeth have fully erupted from the second molar to second molar (with no extraction in the mandibular arch).
5. Mandibular anterior dental crowding (Little’s irregularity index (Little 1975) greater than 6mm)
6. No spaces in the mandibular arch.
7. (Patients with class I molar and skeletal relationship)
8. Patients with normal vertical growth pattern.
9. Normal Systemic and periodontal health.
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| ExclusionCriteria |
| Details |
1. Patients with systemic diseases or any drug therapy that interferes with orthodontic tooth movement.
2. Patients with any abnormal vertical growth pattern and horizontal growth pattern.
3. Patients with blocked out tooth in the lower anteriors.
4. Missing teeth except for third molars treatment with extractions (impacted or unerupted permanent teeth)
5. History of previous orthodontic treatment with either intra-oral or extra-oral appliances (including removable appliances, rapid palatal expansion appliances, or headgear) and functional appliances.
6. Craniofacial syndrome or Skeletal asymmetry (with cleft lip and palate, anomalies, and syndrome).
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Method of Generating Random Sequence
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Stratified block randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Assessment of Alleviation of Crowding, intercanine width, interpremolar width, inter molar width, littles irregularity score. |
preT0 (at the time of wire placement) and post treatment T6 (after 6 weeks) |
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Secondary Outcome
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| Outcome |
TimePoints |
| Assessment of pain perception |
At 4hours (T1), 24hours (T2). 3days (T3), 1week (T4), 1 month (T5) and 6 weeks (T6) |
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Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
08/02/2021 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="2"
Days="1" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This was a randomized controlled trial having a parallel-arm design with an identical allocation ratio of one to one. All the patients were bonded with MBT prescription 0.022x0.028 inch slot (3M unitek) brackets. The patients in group A and group B receives 0.016-inch Cu NiTi and 0.0175-inch Multi-stranded Stainless steel respectively at the initial appointment which is denoted as T0. The Little’s irregularity index was employed to assess the anterior crowding, Intercanine width, Interpremolar width and Intermolar width. at pre- treatment (T 1 ) and post-treatment (T 2 ) stage after 6 weeks. Each of the recruited subject in the study were provided with a specifically designed Visual analogue scale (VAS) diary. They were requested to note the intensity of perceived pain (using the terms ‘0’- no pain to ‘100’- the highest pain) on a 10 cm VAS in the first month, at various time periods such as 4hours, 24hours, 3days, 1week, 1 month and 6 weeks. |