| CTRI Number |
CTRI/2021/03/031853 [Registered on: 09/03/2021] Trial Registered Prospectively |
| Last Modified On: |
06/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment efficiency of two initial orthodontic wires-is there a difference? |
|
Scientific Title of Study
|
Clinical comparison of two initial aligning archwires in terms of alignment efficiency-A double blind randomised 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 |
NASLA P |
| Designation |
Resident in Orthodontics |
| Affiliation |
Government Dental College, Kozhikode |
| Address |
Department of Orthodontics,
Government Dental College,
Government Medical College Campus,
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
919061556624 |
| Fax |
|
| Email |
nasla4apr91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shobha Sundareswaran |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College, Kozhikode |
| Address |
Department of Orthodontics,
Government Dental College,
Government Medical College Campus,
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
919447067245 |
| Fax |
|
| Email |
drshobhakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shobha Sundareswaran |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College, Kozhikode |
| Address |
Department of Orthodontics,
Government Dental College,
Government Medical College Campus,
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
919447067245 |
| Fax |
|
| Email |
drshobhakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College, Kozhikode |
|
|
Primary Sponsor
|
| Name |
NASLA P |
| Address |
Department of Orthodontics
Government Dental College,
Government Medical College Campus,
Kozhikode |
| 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 |
| Nasla P |
Government Dental College, Kozhikode |
Department of Orthodontics
Government Dental College,
Government Medical College Campus,
Kozhikode
Kozhikode
KERALA |
9061556624
nasla4apr91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Dental College, Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Graded CuNiTi arch wires |
Alignment efficiency of graded CuNiTi arch wires during initial orthodontic treatment |
| Comparator Agent |
Conventional CuNiTi arch wires |
Alignment efficiency of conventional CuNiTi arch wires during initial orthodontic treatment |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Angles Class I or Class II malocclusion, Age group 12 to 18 years, Littles irregularity index of minimum 7 mm, Patients with absence of periodontal diseases, No history of medical problems or medications that could influence pain perception |
|
| ExclusionCriteria |
| Details |
Malocclusion correction required treatment procedures other than continuous arch wire mechanics, Patients who had undergone previous active orthodontic treatment, Patients with relevant medical history, Participants taking pain medications for chronic pain, Participants with a positive history of dental pain or pain in the orofacial region
|
|
|
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 |
| To compare the efficiency of alignment of crowding in the maxillary anterior segment between graded CuNiTi with conventional CuNiTi arch wires |
After 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the differences in maxillary inter canine width |
After 4 months |
| Compare the differences in maxillary incisor inclination |
After 4 months |
| Compare the associated pain |
After 4 months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 1 |
|
Date of First Enrollment (India)
|
15/03/2021 |
| 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 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a double blind parallel group clinical trial, comparing the efficiency of alignment of crowding in the maxillary anterior segment between graded CuNiTi with conventional CuNiTi archwires with fixed orthodontic treatment using MBT mechanics. At the start of the procedure patient will be randomly allocated to one of two treatment groups namely group 1 and group 2. Group 1 patients will be receiving graded CuNiTi and group 2 will be receiving conventional CuNiTi archwires. After bracket bonding and archwire insertion, patients will be followed at regular intervals of 2 weeks till completion of initial alignment. Maxillary impressions will be taken on first appointment and there after every 2 weeks. Alignment efficiency will be assessed by Littles irregularity index. Intercanine width will be calculated from models and incisor inclination changes will be assessed using lateral cephalograms. For evaluation of pain visual analogue scale will be used. |