FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077779 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARATIVE EVALUATION OF INTENSIVE AND BIANNUAL APPLICATION OF HALO FLUORIDE VARNISH IN SCHOOL CHILDREN IN REDUCING CARIES INCIDENCE AMONG CHILDREN AGED 6 TO 8 YEARS. 
Scientific Title of Study   Comparative Evaluation Of Intensive And Biannual Application Of HALO FLUORIDE VARNISH In School Children In Reducing Caries Incidence Among Children Aged 6 TO 8 Years. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRutuja Salunkhe  
Designation  Post graduate student 
Affiliation  School of Dental Sciences Krishna Vishwa Vidyapeeth Karad  
Address  Department of Paediatric and Preventive dentistry school of dental sciences ,Krishna Vishwa Vidyapeeth Malkapur,karad.

Satara
MAHARASHTRA
415539
India 
Phone  9356091766  
Fax    
Email  rutujasalunkhe110@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSachin Gugawad 
Designation  Professor 
Affiliation  School of Dental Sciences Krishna Vishwa Vidyapeeth Karad 
Address  Department of Paediatric and Preventive dentistry school of dental sciences ,Krishna Vishwa Vidyapeeth Malkapur,karad.

Satara
MAHARASHTRA
415539
India 
Phone  7499038970  
Fax    
Email  drsachdent15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSachin Gugawad 
Designation  Professor 
Affiliation  School of Dental Sciences Krishna Vishwa Vidyapeeth Karad 
Address  Department of Paediatric and Preventive dentistry school of dental sciences ,Krishna Vishwa Vidyapeeth Malkapur,karad.

Satara
MAHARASHTRA
415539
India 
Phone  7499038970  
Fax    
Email  drsachdent15@gmail.com  
 
Source of Monetary or Material Support  
School of dental sciences krishna vishwavidyapeeth,Malkapur karad 
 
Primary Sponsor  
Name  School of Dental Sciences krishna vishwavidyapeeth karad 
Address  School of dental sciences krishna vishwavidyapeeth,Malkapur karad Pin code:415539 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRutuja salunkhe  school of dental sciences Krishna vishwa vidyapeeth karad  school of dental sciences Krishna vishwa vidyapeeth Malkapur karad
Satara
MAHARASHTRA 
09356091766

rutujasalunkhe110@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Krishna Vishwa vidyapeeth (Deemed to be University),Karad   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  dental caries 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  children with good oral hygiene,age group 6 to 8 years,children without systemic disease children without recent history of antibiotics 
 
ExclusionCriteria 
Details  Children with systemic disease,physical handicap and recent history of antibiotic.children more than 6 to 8 years 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
DMFT,OHIS  4 to 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
DMFT,OHIS  6 months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   20/12/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The aim of the study is to evaluate the efficacy of intensive and biannual application of  Duraflor Halo fluoride varnish in reducing  caries incidence among school children 6 to 8 years. groups so that each group contained 150 children. The

Groups will be formed so that each group will contain 25 children.
The groups will be as follows:
Group 1 (control): Children for whom fluoride varnish will not have been applied.
Group 2 (varnish): Children for whom fluoride varnish will have been applied.

At the baseline examination, children from both groups will have received oral prophylaxis followed by appropriate oral hygiene instructions. Children from the varnish group will have been subjected to intensive application of sodium fluoride varnish (Duraflor Halo Varnish) three times during one week (once every two days). After oral prophylaxis, the teeth will have been dried with an air syringe, and fluoride varnish will have been applied on all teeth using a disposable brush, taking care not to apply it to the soft tissue. The varnish will then be allowed to set for 10 seconds according to the manufacturer’s instructions.

Children who will have received fluoride varnish applications will have been asked to abstain from brushing or flossing for the entire day and will have been instructed to avoid chewing on hard foods, consuming hot drinks, or using products containing alcohol. Children from the control group will not have received varnish applications.

All the children in the control and varnish groups will have been examined clinically at the beginning and at the end of the experimental year. Each child will have been subjected to an ADA Type III oral examination using a mouth mirror and probe. Caries status in primary teeth [DEFT (decayed, extracted, filled teeth) and DEFS (decayed, extracted, filled surfaces)] will have been recorded according to WHO criteria.

Since there will have been a possibility of physiologic exfoliation of primary anterior teeth due to the age group included in the study, to control the bias caused by exfoliated carious incisors, caries status of posterior teeth will have been recorded separately. Caries status for primary posterior teeth (canines, first and second primary molars) will have been recorded as DEFTP (decayed, extracted, filled posterior teeth) and DEFSP (decayed, extracted, filled posterior surfaces) according to WHO criteria. Caries status in permanent teeth [DMFT (decayed, missing, filled teeth) and DMFS (decayed, missing, filled surfaces)] will have been recorded according to WHO criteria.

Two bitewing radiographs will have been obtained for each child at the beginning and at the end of the study. A No. 2 X-ray film will have been placed in the mouth with the help of an intraoral bitewing X-ray film holder to record interproximal surfaces of posterior teeth. A magnifier will have been used to aid in diagnosing incipient proximal lesions from the obtained bitewing radiographs. Radiographically identified proximal carious lesions will have been recorded as RDT (radiographic decayed primary teeth), RDS (radiographic decayed primary surfaces), RDT (radiographic decayed posterior permanent teeth), and RDS (radiographic decayed posterior permanent surfaces).

Using the data recorded on caries at the beginning and at the end of the experimental year, increments in caries will have been calculated.

Oral hygiene status of each child will have been recorded before oral prophylaxis at the beginning and during the one-year follow-up visits as the OHI-S (Oral Hygiene Index-Simplified) index according to WHO criteria. This will have been done to control the bias exerted by oral hygiene status on caries increment.

All the children included in the study will have been examined, and their data will have been recorded respectively by the same examiner.

 

 

 
Close