| CTRI Number |
CTRI/2024/10/075464 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical experiment to compare the clinical survival (i.e., bond failure rate) of a novel color-changing orthodontic adhesive material over a six-month duration Comparing Orthofix Pro with traditional orthodontic adhesive Enlight V |
|
Scientific Title of Study
|
Clinical Evaluation of a New Colour Changing Orthodontic Adhesive Orthofix Pro Versus Conventional Orthodontic Adhesive Enlight V: In Vivo 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 Priya Kumari |
| Designation |
Postgraduate Student |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics ,Room No.7 2nd floor Hitkarini Dental College and Hospital, Dumna Road , Priyadarshani Colony,Jabalpur
Jabalpur
MADHYA PRADESH
482001
India |
| Phone |
7610108765 |
| Fax |
|
| Email |
pk738496@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sarvraj Kohli |
| Designation |
Professor and Head of the Department |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,Room No. 7, 2nd Floor, Hitkarini Dental College and Hospital, Dumna Road , Priyadarshani Colony,Jabalpur
Jabalpur
MADHYA PRADESH
482001
India |
| Phone |
9425152568 |
| Fax |
|
| Email |
sarvraj.kohli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Kumari |
| Designation |
Postgraduate Student |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Room No. 7, 2nd Floor,Hitkarini Dental College and Hospital, Dumna Road , Priyadarshani Colony,Jabalpur
Jabalpur
MADHYA PRADESH
482001
India |
| Phone |
7610108765 |
| Fax |
|
| Email |
pk738496@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hitkarini Dental college and Hospital ,Jabalpur, Madhya Pradesh ,India, Pincode- 482001 |
|
|
Primary Sponsor
|
| Name |
Dr Priya Kumari |
| Address |
Department of orthodontics and Dentofacial Orthopaedics,Room No. 7,2nd Floor Hitkarini Dental College and Hospital, Jabalpur, Madhya Pradesh , India, 482001 |
| 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 Priya Kumari |
Hitkarini Dental College and Hospital |
Department of Orthodontics and Dentofacial Orthopaedics, Room No. 7, 2nd Floor, Hitkarini Dental College and Hospital, Dumna Road ,Jabalpur,Madhya Pradesh, Pincode - 482001
Jabalpur
MADHYA PRADESH |
7610108765
pk738496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee on Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K002||Abnormalities of size and form ofteeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Enlight V |
Ormco Enlight V Light Cure Adhesive- orthodontic adhesive with Bis-GMA resin
Company name - Ormco
|
| Intervention |
Orthofix Pro |
Orthofix Pro- Orthodontic Adhesive with Chroma Technology (Light Cure Orthodontic Colour Changing Bonding System) - 2x3 grams - R&D Trial Pack bearing Batch No. 20- R-1
Company name- Anabond Stedman Pharma Research (P) Limited. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Complete permanent dentition.
Patient requiring fixed appliance therapy in both arches.
Both extraction and non-extraction cases.
Absence of labial or buccal restoration.
No history of active or previousorthodontic treatment.
No hypoplastic lesion in enamel.
Good oral hygiene. |
|
| ExclusionCriteria |
| Details |
Patient with congenital enamel defects.
Patient with missing tooth.
Patient with craniofacial anomalies.
Patient with restorations and crown.
Patient who requires orthognathic surgical treatment.
Patient who presents with traumatic occlusion |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical survival (i.e. bond failure rate) over a six-month period of a new color changing orthodontic adhesive Orthofix Pro versus conventional orthodontic adhesive Enlight V. |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the mode of bracket failure according to adhesive remnant index (ARI) |
6 Months |
| To determine the in-vivo orthodontic bracket failure rates with respect to patient’s gender, type of tooth, type of quadrant, arch and position of tooth (anterior and posterior) |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
31/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pk738496@gmail.com].
- For how long will this data be available start date provided 01-10-2024 and end date provided 02-03-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This study is a randomized , participant blinded , parallel group, active controlled trial, comparing the clinical survival (i.e. bond failure rate) over a six-month period of a new color changing orthodontic adhesive Orthofix Pro versus conventional orthodontic adhesive Enlight V in 24 patients that will be conducted in Hitkarini dental college and Hospital ,Jabalpur ,Madhya Pradesh, India. The primary outcome measures will be clinical survival (i.e. bond failure rate) over a six-month period of a new color changing orthodontic adhesive Orthofix Pro versus conventional orthodontic adhesive Enlight V over a six-month period . The secondary outcomes will be the orthodontic bracket failure rates with respect to patient’s gender, type of tooth, type of quadrant, arch and position of tooth (anterior and posterior) and to determine the mode of bracket failure according to adhesive remnant index (ARI) at every consecutive month over a six-month period . |