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CTRI Number  CTRI/2020/09/028036 [Registered on: 24/09/2020] Trial Registered Prospectively
Last Modified On: 16/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Other 
Public Title of Study   A clinical trial to see the effect of occlusal pit and fissure sealant in preventing and arresting the caries incidence among adult population. 
Scientific Title of Study   Efficacy of occlusal pit and fissure sealant in moderate and high caries risk adult patients: A single blind, randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  smriti Jha 
Designation  Junior Resident 
Affiliation  AIIMS , New Delhi 
Address  3rd floor, CDER, AIIMS, Ansari nagar, 110029

New Delhi
DELHI
110029
India 
Phone  8595195893  
Fax    
Email  drsmrit.aiims12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amrita Chawla 
Designation  Associate Professor 
Affiliation  AIIMS , New Delhi 
Address  3rd floor, CDER, AIIMS, Ansari nagar, 110029

New Delhi
DELHI
110049
India 
Phone  9871445522  
Fax    
Email  dr.amritachawla@gmail.com  
 
Details of Contact Person
Public Query  
Name  smriti Jha 
Designation  Junior Resident 
Affiliation  AIIMS , New Delhi 
Address  3rd floor, CDER, AIIMS, Ansari nagar, 110029

New Delhi
DELHI
110029
India 
Phone  8595195893  
Fax    
Email  drsmrit.aiims12@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  Smriti Jha 
Address  498/2, haridevpuri, gautam nagar, 110043 
Type of Sponsor  Other [self] 
 
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 
Smriti jha  AIIMS  3rd floor,Department of Conservative Dentistry and Endodontics, CDER, AIIMS, Ansari nagar, New Delhi, 110049
New Delhi
DELHI 		 8595195893

drsmrit.aiims12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
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  pit and fissure sealant  This is a flowable material applied onto deep pit and fissures of teeth to prevent them from future decay as a part of minimal invasive dentistry. It will be applied once and in case it gets dislodged reapplication will be done but will be counted as failure. The same will be followed up for 1 year 
Comparator Agent  Placebo cpontrol  Teeth will be placebo treated with syringe and water. This will be done only once at the treatment. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Healthy patients between the age group of 19-40 years.
2.Patients diagnosed as moderate or high caries risk according to caries risk assigned by CAMBRA
3. Contralateral pair of periodontally sound maxillary/mandibular first and second molar teeth requiring pit and fissure sealants according to ICDAS II(score 0-2)
4. Radiographically the lesion limited to outer 1/3rd of dentin.
5. Molar-supported permanent dentitions free of any edentulous spaces and occlusal interferences. 
 
ExclusionCriteria 
Details  1.Patients having allergies or adverse medical history
2.Patient with any intrinsic staining of the teeth and any existing tooth-coloured restorations
3.Patient having a history of bruxism/ attrition
4.Patient under low and extreme caries risk
5.Patients with absence of adjacent and antagonist teeth
Clinically detectable caries (ICDAS II code 3-6)
Radiographically lesion extending beyond outer 1/3rd of dentin
Teeth with periodontal problems
Teeth formerly subjected to vital pulp therapy.
Teeth in cross bite, deep bite and/or other malocclusions
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Caries Incidence  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Sealant Retention  3 months follow up 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   15/10/2020 
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   Once  patients agree to participate in the study, they will be assessed based on the inclusion criteria. They will be provided with a toothpaste (if necessary), mouth-rinse and a chewing gum. The teeth will be cleaned. The teeth will be evaluated for presence or absence of caries.They will be recalled and your non decayed or teeth that has started to decay will be treated with some material applied on to it. This will prevent the occurrence of caries on  tooth. Regular follow up will be arranged at 3-month interval for 1 year to check the caries status. X-rays will be taken at the end of treatment and at 6 and 12 months to observe the caries status. 
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