| CTRI Number |
CTRI/2025/08/092138 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy
Preventive
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How to Protect Teeth from White Spots During Braces: A Study on Different Coatings and Sealant |
|
Scientific Title of Study
|
A comparative evaluation of white spot lesions on application of nonfluoride resin sealant, fluoride resin sealant and varnish during fixed orthodontic treatment : 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 Suresh Kangane |
| Designation |
Principal , Professor |
| Affiliation |
MIDSR Dental college Latur |
| Address |
Room NO. 7 , 1st floor, Department of orthodontic and dentofacial Orthopedics MIDSR Dental College, Latur Maharashtra 413512 India
Department of orthodontic and dentofacial Orthopedics MIDSR Dental College, Latur Maharashtra 413512 India
Latur
MAHARASHTRA
413512
India |
| Phone |
9823267063 |
| Fax |
|
| Email |
drsureshkangane@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Honrao |
| Designation |
Postgraduate |
| Affiliation |
MIDSR Dental college Latur |
| Address |
Room NO. 7 , 1st floor, Department of orthodontic and dentofacial Orthopedics MIDSR Dental College, Latur Maharashtra 413512 India
Department of orthodontic and dentofacial Orthopedics MIDSR Dental College, Latur Maharashtra 413512 India
Latur
MAHARASHTRA
413512
India |
| Phone |
7378658801 |
| Fax |
|
| Email |
sumithonrao143@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Honrao |
| Designation |
Postgraduate |
| Affiliation |
MIDSR Dental college Latur |
| Address |
Room NO. 7 , 1st floor, Department of orthodontic and dentofacial Orthopedics MIDSR Dental College, Latur Maharashtra 413512 India
Department of orthodontic and dentofacial Orthopedics MIDSR Dental College, Latur Maharashtra 413512 India
Latur
MAHARASHTRA
413512
India |
| Phone |
7378658801 |
| Fax |
|
| Email |
sumithonrao143@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sumit Honrao |
| Address |
Department of orthodontic and dentofacial Orthopedics MIDSR Dental College, Latur Maharashtra 413512 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 Sumit Honrao |
MIDSR DENTAL COLLEGE, LATUR |
Department of orthodontic and dentofacial Orthopedics, department no.7 , first floor, MIDSR Dental College, Latur Maharashtra 413512 India
Latur
MAHARASHTRA |
7378658801
sumithonrao143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe MIDSR Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MI Varnish |
Casein phosphopeptides, Amorphous Calcium Phosphate (ACP) |
| Comparator Agent |
Transbod plus |
silane-treated quartz and bisGMA |
| Intervention |
Transbond XT |
Bisphenol A Diglycidyl Ether Dimethacrylate (BisGMA) and Triethylene Glycol Dimethacrylate (TEGDMA) |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Understanding and willingness to provide informed consent
2. Patients between 15-25 years of age undergoing fixed
orthodontic treatment with metal brackets
3. Patients with good and fair oral hygiene
4. Patients with satisfactory general health
5. Patients with mild dental crowding |
|
| ExclusionCriteria |
| Details |
1. Enamel hypoplasia
2. Amelogenesis imperfecta
3. Fluorosis
4. Active periodontal disease
5. Active dental caries
6. Patients having frontal fillings, veneers or other
reconstructions.
7. Patients having other structural defects of enamel. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectivness of nonfluoride resin sealant, fluoride resin sealant and varnish in prevention of white spot lesion during fixed orthodontic treatment. |
9 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectivness of nonfluoride resin sealant, fluoride resin sealant and varnish in prevention of white spot lesion during fixed orthodontic treatment. |
9 month |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/08/2025 |
| 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 comparative evaluation of white spot lesions on application of nonfluoride resin sealant, fluoride resin sealant and varnish during fixed orthodontic treatment. Varnish which contains sodium fluoride (NaF) and casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP), has been shown in vitro to be superior to fluoride varnish with NaF alone in preventing incipient caries. The EDI index is used for visual evaluation of the labial surfaces of the anterior teeth in maxilla.The examination scoring will be performed under direct illumination in natural light after drying the teeth with compressed air for five seconds |