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CTRI Number  CTRI/2026/04/107967 [Registered on: 09/04/2026] Trial Registered Prospectively
Last Modified On: 07/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Effect of 2×4 appliance (early fixed braces) on correcting misaligned teeth in children with mixed dentition 
Scientific Title of Study   The role of 2X4 appliance in early management of malocclusion in mixed dentition: A clinical study 
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 ZIAUDDIN MOHAMMAD 
Designation  PROFESSOR 
Affiliation  Sri Sai College of Dental Surgery Hospital 
Address  Department of Pediatric and Preventive Dentistry, Room No: 9, Sri Sai College of Dental Surgery, 1-2-64/1 and 2, Opposite Shiv Sagar Lake, Kothrepally, Vikarabad, Telangana – 501102, India

Hyderabad
TELANGANA
501102
India 
Phone  7981999423  
Fax    
Email  dr.ziamohammad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ZIAUDDIN MOHAMMAD 
Designation  PROFESSOR 
Affiliation  Sri Sai College of Dental Surgery Hospital 
Address  Department of Pediatric and Preventive Dentistry, Room No: 9, Sri Sai College of Dental Surgery, 1-2-64/1 and 2, Opposite Shiv Sagar Lake, Kothrepally, Vikarabad, Telangana – 501102, India

Hyderabad
TELANGANA
501102
India 
Phone  7981999423  
Fax    
Email  dr.ziamohammad@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ZIAUDDIN MOHAMMAD 
Designation  PROFESSOR 
Affiliation  Sri Sai College of Dental Surgery Hospital 
Address  Department of Pediatric and Preventive Dentistry, Room No: 9, Sri Sai College of Dental Surgery, 1-2-64/1 and 2, Opposite Shiv Sagar Lake, Kothrepally, Vikarabad, Telangana – 501102, India

Hyderabad
TELANGANA
501102
India 
Phone  7981999423  
Fax    
Email  dr.ziamohammad@gmail.com  
 
Source of Monetary or Material Support  
SRI SAI COLLEGE OF DENTAL SURGERY 1-2-64/1 AND 2 OPPOSITE SHIV SAGAR LAKE KOTHREPALLY VIKARABD TELANGANA 501102 
 
Primary Sponsor  
Name  DIVYA JATOTH 
Address  SRI SAI COLLEGE OF DENTAL SURGERY 1-2-64/1 AND 2 OPPOSITE SHIV SAGAR LAKE KOTHREPALLY VIKARABD TELANGANA 501102 
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 
DIVYA JATOTH  Sri Sai College of Dental Surgery  Department of Pediatric and Preventive Dentistry, Room No: 9, Sri Sai College of Dental Surgery, 1-2-64/1 and 2, Opposite Shiv Sagar Lake, Kothrepally, Vikarabad, Telangana – 501102, India
Hyderabad
TELANGANA 
7981999423

divyadj6677@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SAI COLLEGE OF DENTAL SURGERY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2×4 Fixed Orthodontic Appliance  2×4 fixed orthodontic appliance consisting of molar bands and incisor brackets connected with archwire will be used for early correction of malocclusion in mixed dentition. Patients will be reviewed every 3–4 weeks, and treatment will continue until desired alignment is achieved. Pre- and post-treatment dental arch parameters will be recorded. 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Crowding in the anterior segment
2. Crossbites
3. Midline diastemas
4. Rotated teeth
5. Spaced upper incisors
6. Ectopically erupted teeth
7. No previous history of orthodontic treatment
 
 
ExclusionCriteria 
Details  1. Primary dentition
2. Partially erupted permanent teeth
3.Uncopertive/special needs children
4. Children with known systemic disorders
5. Children without parental consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study is to evaluate the effectiveness of the 2×4 appliance by assessing changes in dental arch parameters, including intercanine width, intermolar width, arch depth, arch length, and arch perimeter, measured on study models before and after completion of treatment.  Baseline (pre-treatment) and post-treatment (after completion of 2×4 appliance therapy) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   21/04/2026 
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="3"
Days="3" 
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 - NO
Brief Summary  

Brief Resume of Study

 The mixed dentition stage refers to the period in a child’s dental development when both primary teeth and permanent teeth are present.  This transitional phase typically occurs between the ages of 6 and 12 years old.  During this time, the eruption of permanent teeth can lead to various dental issues, commonly referred to as malocclusions.  These include crowding, anterior and posterior crossbites, midline diastema, rotations, and ectopically erupted teeth.

   These malocclusions are often self-correcting, as permanent ones gradually replace the primary teeth.  However, some issues may persist or worsen without intervention. In such cases, early orthodontic treatment, known as interceptive orthodontics, can be beneficial. This approach aims to address developing malocclusions during the mixed dentition phase, often preventing the need for more complex treatments later on. The goal of interceptive treatment is to guide the development of the teeth and jaws to ensure proper alignment and occlusion.

   Interceptive orthodontics can take various forms, including removable appliances and fixed devices. One of the most commonly used fixed appliances is 2x4 appliance. The 2x4 appliance is a versatile orthodontic tool designed to correct various issues that often arise during mixed dentition. This appliance typically consists of four brackets placed on the permanent incisors and two molar bands cemented on the first permanent molars connected by an archwire.  It is particularly effective in addressing malocclusion early in mixed dentition.

The primary advantage of using the 2x4 appliance, during the mixed dentition period is that it provides early intervention. This can not only improve the alignment of the teeth and bite but can also reduce the need for more extensive orthodontic work in the future. Additionally, since this phase is a time of significant dental growth and development, early treatment can help guide the growth of the jaw and teeth, promoting normal occlusion.

 
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