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CTRI Number  CTRI/2022/08/044891 [Registered on: 24/08/2022] Trial Registered Prospectively
Last Modified On: 23/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   comparison of three different dental sealants to prevent dental decay 
Scientific Title of Study   Comparative evaluation of retention and caries incidence of three different pit and fissure sealants using “CCC” evaluation system- A Double Blinded Randomized Controlled Clinical Trials  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hariprasath Nagarajan 
Designation  Post graduate student - II year, Department of public health dentistry 
Affiliation  Saveetha dental college and hospital  
Address  Saveetha dental college, 162, PH road, velappanchavadi, chennai

Chennai
TAMIL NADU
639006
India 
Phone  8056720879  
Fax    
Email  drharithedentist@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrJayashree Prabakar 
Designation  Reader, Department of public health dentistry 
Affiliation  Saveetha dental college and hospital  
Address  Saveetha dental college, 162, PH road, velappanchavadi, chennai

Chennai
TAMIL NADU
600077
India 
Phone  7904181675  
Fax    
Email  shrijaya2009@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Hariprasath Nagarajan 
Designation  Post graduate student - II year, Department of public health dentistry 
Affiliation  Saveetha dental college and hospital  
Address  Saveetha dental college, 162, PH road, velappanchavadi, chennai

Chennai
TAMIL NADU
600077
India 
Phone  8056720879  
Fax    
Email  drharithedentist@gmail.com  
 
Source of Monetary or Material Support  
Saveetha dental college and hospital, Chennai 
 
Primary Sponsor  
Name  Dr Hariprasath Nagarajan 
Address  Saveetha dental college and hospital, 162-PH road, velappanchavadi, Chennai  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mr Augustin chelladurai  Joy bell matriculation school  Joy bell matriculation school, No.14 James street extension, Poonamallee, Thiruvallur
Thiruvallur
TAMIL NADU 
9150750874

joybellmatric@gmail.com 
Xavier Kumar  Popli Raja Government higher secondary school  Surapet Main Rd, Kathirvedu, Puzhal, Chennai-600066
Chennai
TAMIL NADU 
9884507099

drharithedentist@gmail.com 
Mrs Kavitha  Public Union Middle School,  village- Mappedu Block Name- Kadambathur District - Thiruvallur State- Tamil Nadu
Thiruvallur
TAMIL NADU 
9655787303

drharithedentist@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional human ethics committee   Approved 
Joy bell matriculation school, Poonamallee   No Objection Certificate 
Popili Raja government highschool  No Objection Certificate 
Public union middle school, samathuvapuram  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IONOSEAL  Ionoseal® is a light-curing glass ionomer composite cement for linings, extended fissure sealing and treatment of smaller lesions.follow up for 1 year 
Comparator Agent  ULTRASEAL XT HYDRO  UltraSeal XT hydro hydrophilic pit and fissure sealant is a light-cured, radiopaque, fluoride-releasing composite sealant.follow up for 1 year 
Intervention  VOCO twinky star flow (compomer)  Compomers are recently introduced products marketed as a new class of dental materials. These materials are said to provide the combined benefits of composites (the "comp" in their name) and glass ionomers ("omer"). follow up for 1 year 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children aged 12-15 years old who were apparently healthy without any known history of systemic illness, whose parents consented for their participation and teeth with ICDAS scoring 0,1 and 2 are the inclusion of the study 
 
ExclusionCriteria 
Details  Children with suspected caries, enamel hypoplasia, or dental fluorosis and children who were uncooperative or refused dental treatment. Children who developed any complications during the study period were excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
CCC evaluation system -
Discolouration, retention rate and coverage 
3rd,6th,9th and 12th month 
 
Secondary Outcome  
Outcome  TimePoints 
color change in the dental sealant, coverage of the sealant and secondaries caries at 3rd, 6th, 9th and 12th month  1 year 
 
Target Sample Size   Total Sample Size="246"
Sample Size from India="246" 
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)   16/02/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The dental council of India National Oral Health Survey from 2002-2003 revealed the prevalence of dental caries is 49.8% with a mean decayed, missing and filled teeth (DMFT) index of 2.5 among 12 years old individuals and 3.4 among the 15 years old individuals. With this picture in mind, the public health dentist has a moral obligation to spread awareness on oral diseases and to promote oral health ultimately leading to a better quality of life. In alignment with the principle of “prevention is better than cure”, in depth research on pit and fissure sealants can prove to be a valuable tool in reduction of mean DMFT rate in a community. In consequence, a double blinded randomized controlled clinical trial will be done using three different pit and fissure sealant among 12 to 15 year old young adolescents in rural Tamil Nadu with the follow up of 1 year where the evaluation will be done every 3 months interval. A total of 246 participants were randomly allocated to three groups (n=82).

VOCO twinky star flow (Compomer) , Ionoseal (Flowable GIC), and Ultraseal XT hydro (Hydrophilic sealant) are the three different types of sealants that will be used in the trial.. A single operator will perform the sealant application in the allocated tooth during the single visit.

The followup examination and evaluation of the pit and fissure sealant will be performed by the primary investigator who was blinded to interventional groups. At 3, 6, 9 and 12 month intervals, the sealants will be evaluated using the CCC evaluation system.

 
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