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CTRI Number  CTRI/2024/10/075100 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of efficiency in decrowding of anterior teeth using brackets with single or double slot 
Scientific Title of Study   Assessment of alignment efficiency of lower anterior crowding using single versus double slot brackets–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  DR Shobha Sundareswaran 
Designation  Professor 
Affiliation  KMCT Dental College 
Address  Department of Orthodontics and Dentofacial Orthopedics, KMCT Dental College KMCT Medical College Campus, Mukkam, Kozhikode 673602

Kozhikode
KERALA
673602
India 
Phone  9447067245  
Fax    
Email  drshobhakumar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Shobha Sundareswaran 
Designation  Professor 
Affiliation  KMCT Dental College 
Address  Department of Orthodontics and Dentofacial Orthopedics, KMCT Dental College KMCT Medical College Campus, Mukkam, Kozhikode 673602

Kozhikode
KERALA
673602
India 
Phone  9447067245  
Fax    
Email  drshobhakumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Shobha Sundareswaran 
Designation  Professor 
Affiliation  KMCT Dental College 
Address  Department of Orthodontics and Dentofacial Orthopedics, KMCT Dental College KMCT Medical College Campus, Mukkam, Kozhikode 673602

Kozhikode
KERALA
673602
India 
Phone  9447067245  
Fax    
Email  drshobhakumar@gmail.com  
 
Source of Monetary or Material Support  
KMCT Dental College , KMCT Medical College Campus, Mukkam, Kozhikode,Kerala,India 673602 
 
Primary Sponsor  
Name  DR FASIL KT 
Address  KMCT Dental College , KMCT Medical College Campus, Mukkam, Kozhikode 673602 
Type of Sponsor  Other [Self funded] 
 
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 
Dr Fasil KT  KMCT Dental College  5th floor,Department of orthodontic and dentofacial orthopedics.
Kozhikode
KERALA 		 8281938718

dr.fasilktkyl@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMCT DC ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Double Slot Brackets  Alignment Efficiency of Lower Anterior Crowding Using Double Slot Brackets 
Comparator Agent  Single Slot Brackets  Alignment Efficiency of Lower Anterior Crowding Using single Slot Brackets 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Age group – 15 to 25 years .
2. Crowding in the lower anterior segment providing a Little’s irregularity index 6-9mm
requiring fixed orthodontic treatment.
3. Needing first premolar extraction.
4. All teeth erupted upto the second molars in the lower arch. 
 
ExclusionCriteria 
Details  1. Patients giving history of medical problems or taking medications that could influence pain
perception.
2. Active periodontal diseases.
3. Previous history of orthodontic treatment.
4. Patients taking pain medications that may induce root resorption. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Alignment efficiency as assessed by resolution of lower anterior crowding  Five months 
 
Secondary Outcome  
Outcome  TimePoints 
1.The axial inclination of lower incisors before commencement of treatment and after
complete alignment using lateral cephalogram.
2.Pain perception using VAS (visual analogue scale)
3.Evidence of root resorption before and after completion of alignment with the help of
CBCT (cone beam computed tomography) 		 Five months 
 
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" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2024 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.fasilktkyl@gmail.com].

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 01-01-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information -  NIL
Brief Summary  
The aim of the present study is to evaluate and compare the alignment efficiency of double versus single slot brackets during initial alignment of crowding using the Preadjusted Edgewise Appliance System.32 patients will be recruited based on inclusion and exclusion criteria and randomly allocated to interventional/comparator groups.After achieving complete alignment the primary and secondary outcomes will be evaluated.
 
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