| 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
|
|
|
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 |
|
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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
|
|
|
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.
|
|
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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. | |