| CTRI Number |
CTRI/2024/08/071817 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Tooth Surface Hardening Effect of Bioglass Containing Fluoride Coating on the White Coloured Spots present on Milk Teeth of Children with Childhood Caries in Comparison with Regularly used Fluoride Coating- A Clinical Study |
|
Scientific Title of Study
|
Remineralization effect of bioactive glass fluoride varnish on white spot lesions in primary teeth of children with early childhood caries in comparison with conventional fluoride varnish a randomized controlled 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 |
Avnee Kalia |
| Designation |
Post Graduate student |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences Mangalore, Light House Hill Road, Hampankatta, Mangalore, Karnataka 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9967987519 |
| Fax |
|
| Email |
avneekalia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avnee Kalia |
| Designation |
Post Graduate student |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences Mangalore, Light House Hill Road, Hampankatta, Mangalore, Karnataka 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9967987519 |
| Fax |
|
| Email |
avneekalia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suprabha BS |
| Designation |
Professor and Head |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences Mangalore, Light House Hill Road, Hampankatta, Mangalore, Karnataka 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9480655538 |
| Fax |
|
| Email |
suprabha.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences Mangalore |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences Mangalore |
| Address |
Light House Hill Road, Mangalore, Karnataka 575001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Avnee Kalia |
Manipal College of Dental Sciences Mangalore |
2nd Floor, Department 6, Department of Pediatric and Preventive Dentistry, Dental Annexure Building, Manipal College of Dental Sciences Mangalore, Light House Hill Road, Hampankatta, Mangalore 575001.
Dakshina Kannada
KARNATAKA |
9967987519
avneekalia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Manipal College of Dental Sciences Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fluoritop SR Varnish
Slow-release topical dental fluoride varnish |
0.5 ml of varnish will be dispensed on glass dappen dish. Teeth will be air-dried, varnish will be applied uniformly across all teeth surfaces using an applicator tip and be air-dried for 15-20 seconds to ensure setting.
In the next two sittings, only the teeth with White Spot Lesions will receive varnish application. |
| Intervention |
FluoroDip Bioactive
Sodium fluoride containing dental varnish fortified with bioactive glass |
0.5 ml of varnish will be dispensed on glass dappen dish. Teeth will be air-dried, varnish will be applied uniformly across all teeth surfaces using an applicator tip and be air-dried for 15-20 seconds to ensure setting. In the next two sittings, only the teeth with White Spot Lesions will receive varnish application. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children with non-cavitated white spot lesions on the buccal and lingual surfaces of primary teeth with ICDAS score 1 (first visual change in enamel after air drying) and ICDAS score 2 (distinct visual change in enamel even when wet).
Children exhibiting Frankl’s definitely positive, positive and negative behaviour. |
|
| ExclusionCriteria |
| Details |
Children exhibiting Frankl’s definitely negative behaviour.
Children with systemic and mental illness.
Tooth with cavitated lesions.
Tooth nearing exfoliation time.
Tooth with developmental defects.
History of allergy to colophony base (resin). |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this study will be to evaluate the extent of remineralization on the non-cavitated enamel white spot lesions on the primary teeth of children with ECC at 6 month and 1 year follow-up by bioactive glass fortified sodium fluoride varnish in comparison with conventional sodium fluoride varnish applied with an intensive application regimen (3 applications in two weeks), using laser fluorescence (DIAGNOdent). |
6 month and 12 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the lesion activity status of the white spot lesions on the primary tooth surfaces of children with ECC using ICDAS-LAA classification at 6 month and 1 year follow-up after application of bioactive glass fortified sodium fluoride varnish in comparison with conventional sodium fluoride varnish.
To assess the dental caries experience level of the children with ECC at 6 month and 1 year follow-up after application of bioactive glass fortified sodium fluoride varnish in comparison with conventional sodium fluoride varnish. |
6 month and 12 month follow up |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| Date of Study Completion (India) |
15/01/2026 |
| 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 - NO
|
Brief Summary
Modification(s)
|
The aim of this study was to evaluate the remineralizing effect of sodium fluoride containing dental varnish fortified with bioactive glass on the white spot lesions in primary teeth of children with early childhood caries (ECC). The time period of this study was 24 months including 12-month follow-up. The study was conducted in the Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences Mangalore. Children were screened according to the inclusion criteria and divided into two groups- Group 1- Sodium fluoride varnish (Fluoritop SR Varnish) Group 2- Sodium Fluoride containing dental varnish fortified with bioglass (FluoroDip Bioactive)
The dmft, plaque index and a questionnaire on oral health practices to gather baseline data was recorded. The teeth were dried and DIADNOdent pen readings were taken for teeth with White Spot Lesions. All patients underwent oral prophylaxis with ultrasonic scaler and polishing using non-fluoridated prophylaxis paste in first visit. For both groups, 0.5ml of varnish was applied on dried teeth using an applicator brush and air dried for 15-20 seconds to ensure setting. The teeth with WSL received two more applications of fluoride varnish within a 2-week period using the same procedure described above for their corresponding fluoride varnishes, thus amounting to 3 applications in 2 weeks for the white spot lesions. DIAGNOdent pen readings and ICDAS-LAA score were recorded at baseline, 6-month and 12-month follow-ups. The dmft, plaque index and a questionnaire on oral health practices were recorded at baseline and 12-month follow-up.
Results: There was a significant reduction in the DIAGNOdent pen readings at 6-month and 12-month follow-ups in both groups, with no significant difference in reduction between groups. There was also a significant reduction in number of active lesions within both treatment groups, with no significant difference between the groups. |