| CTRI Number |
CTRI/2025/09/094025 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
An In Vivo and In Vitro Study on Fluoride Release from Four Restorative Materials and Their Response to Fluoride Recharge |
|
Scientific Title of Study
|
Comparative evaluation of fluoride release of four restorative materials and their rechargeability using three topical fluoride agents an in vivo and in vitro 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 Bhagya S Kumar |
| Designation |
Post Graduate student at Post Graduate Institute of Dental Sciences Rohtak |
| Affiliation |
|
| Address |
Department of Pediatric and Preventive Dentistry,
Post Graduate Institute of Dental Sciences, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7736530525 |
| Fax |
|
| Email |
bhagyasreekumar98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Singhal |
| Designation |
Associate Professor at Post Graduate Of Dental Sciences , Rohtak |
| Affiliation |
|
| Address |
Department of Pediatric and Preventive Dentistry,
Post Graduate Institute of Dental Sciences, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
singhal84ruchi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagya S Kumar |
| Designation |
Post Graduate student at Post Graduate Institute of Dental Sciences Rohtak |
| Affiliation |
|
| Address |
department of pediatric and preventive dentistry,
post graduate institute of dental sciences, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7736530525 |
| Fax |
|
| Email |
bhagyasreekumar98@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhagya S Kumar |
| Address |
post graduate institute of dental science , rohtak |
| Type of Sponsor |
Other [self sponsored study] |
|
|
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 Bhagya S Kumar |
Post Graduate Institute of Dental Sciences, Rohtak |
Department pf Pediatric and Preventive Dentistry, Room no 19
Rohtak
HARYANA |
7736530525
bhagyasreekumar98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| biomedical and health research ethics committee, PGIDS ,Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
flouride varnish, dentrifice, remineralising agent |
Fluoride recharging materials are tested to assess the fluoride release with a control group on day 1,15 and 30 |
| Intervention |
restoration of the tooth |
restoration of the decayed tooth is done with a restortive material is done and recarging material is applied and patient is kept under follow up of 30 days with flouride being asessed on day 1,15 and 30 |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
children with a single decayed tooth in the oral cavity will be included, participants should be healthy with no prior exposure to topical fluoride (e.g., fluoride gels or varnish) or systemic fluoride |
|
| ExclusionCriteria |
| Details |
those with multiple restored teeth or requiring multiple restorations will be excluded. Medically compromised children and those undergoi ng orthodontic treatment will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the flouride content in the salive is measured |
base line flouride concentration is measured before the study and after intervention flouride levels in saliva is measured on day 1,15 and 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decreased caries incidence in adjacent teeth or reduced rate of recurrent caries in the present tooth |
1 year |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/11/2025 |
| 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="0"
Months="10"
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
|
This study examines the fluoride release and rechargeability of dental restorative materials important for long-term caries prevention. We will evaluate four materials (Type 2 GIC, Zirconia-reinforced GIC, Giomer, UDMA-based material) and three topical fluoride agents in in-vitro and in-vivo conditions. In-vitro analysis will track fluoride release and post-recharge effects. In-vivo, 160 children will be restored using the best in-vitro material, with salivary fluoride measured at specified intervals. Our goal is to identify the best-performing materials and agents, thereby offering evidence-based recommendations for pediatric dental care. |