| CTRI Number |
CTRI/2025/12/099786 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to evaluate the effectiveness of advanced ceramic materials for correcting the improperly placed teeth in patients undergoing braces treatment |
|
Scientific Title of Study
|
Evaluating the clinical performance of alumina, zirconia, zirconia toughened alumina (ZTA), and alumina toughened zirconia(ATZ) ceramic based dental materials as orthodontic brackets, dental implants, full veneer crowns and fixed partial dentures |
| 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 Pradeep Kandikatla |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Orthodontics, Room No.6, Block 3, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9603217449 |
| Fax |
|
| Email |
pkandikatla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prosenjit Das |
| Designation |
Assistant Professor |
| Affiliation |
Indian Institute of Science |
| Address |
Department of Materials Engineering
Indian Institute of Science
Bangalore
Bangalore
KARNATAKA
560012
India |
| Phone |
9531590074 |
| Fax |
|
| Email |
prosenjitdas@iisc.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prosenjit Das |
| Designation |
Assistant Professor |
| Affiliation |
Indian Institute of Science |
| Address |
Department of Materials Engineering
Indian Institute of Science
Bangalore
Chittoor
KARNATAKA
560012
India |
| Phone |
9531590074 |
| Fax |
|
| Email |
prosenjitdas@iisc.ac.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh, India-534202 |
|
|
Primary Sponsor
|
| Name |
Dr Prosenjit Das |
| Address |
Department of Materials Engineering,
Indian Institute of Science,
Bangalore-560012, Karnataka, India |
| 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 |
| Dr Pradeep Kandikatla |
Vishnu Dental College |
Department of Orthodontics, Room No.6,2nd Floor, Block 3, Vishnupur, Bhimavaram, India-534202
West Godavari
ANDHRA PRADESH |
9603217449
pkandikatla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M264||Malocclusion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alumina Orthodontic Bracket |
Polycrystalline Alpha Alumina brackets will be placed for a duration of one year in patients undergoing fixed orthodontic treatment for malocclusion |
| Comparator Agent |
Polycrystalline ceramic brackets |
Polycrystalline ceramic brackets will be placed for a duration of one year in patients undergoing fixed orthodontic treatment for malocclusion |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Fixed Orthodontic Treatment
2.Mild to Moderate Crowding |
|
| ExclusionCriteria |
| Details |
1. Enamel Defects
2. Active Caries
3. Periodontal Disease
4. Systemic Disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bracket debonding rate |
1st Month
2nd Month
3rd Month
4th Month
5th Month
6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vas pain Score |
4 hours, 24 hours, day 3, and day 7 |
| change in the Littles irregularity index |
1st month
2nd month
3rd month
4th month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
05/01/2026 |
| 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="6"
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 - NO
|
|
Brief Summary
|
A newly developed ceramic orthodontic bracket has been manufactured based on existing market designs and requires clinical evaluation. Clinical efficiency can be assessed through bracket survival, patient-reported pain and discomfort, and the effectiveness of initial tooth alignment. The aim of the study is to evaluate the clinical performance of a newly developed ceramic orthodontic bracket over a 6-month period. |