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CTRI Number  CTRI/2023/06/053393 [Registered on: 01/06/2023] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of two newer pit and fissure sealants for preventing dental caries in children 
Scientific Title of Study   Comparison of the success Rate of microFilled and nanofilled resin-based fissure sealants: A randomised control trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  GAURI KALRA YADAV 
Designation  PROFESSOR 
Affiliation  DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY 
Address  DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY ROOM NUMBER 6 SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH KHERI MORE SECTOR 89 FARIDABAD
Faridabad
HARYANA
121002
India 
Phone  9910329898  
Fax    
Email  drgauri_dentist@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  GAURI KALRA YADAV 
Designation  PROFESSOR 
Affiliation  DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY 
Address  DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY ROOM NUMBER 6 SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND SCIENCES
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH KHERI MORE SECTOR 89 FARIDABAD
Faridabad
HARYANA
121002
India 
Phone  9910329898  
Fax    
Email  drgauri_dentist@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  GAURI KALRA YADAV 
Designation  PROFESSOR 
Affiliation  DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY 
Address  DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY ROOM NUMBER 6 SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH KHERI MORE SECTOR 89 FARIDABAD
Faridabad
HARYANA
121002
India 
Phone  9910329898  
Fax    
Email  drgauri_dentist@yahoo.co.in  
 
Source of Monetary or Material Support  
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH, FARIDABAD 
 
Primary Sponsor  
Name  GAURI KALRA YADAV 
Address  SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
PRIYA MENDIRATTA  SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
GAURI KALRA YADAV  SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH  DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY ROOM NO. 6 SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH KHERI MORE SECTOR 89 FARIDABAD
Faridabad
HARYANA 
9910329898

drgauri_dentist@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
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  E-Pit and Fissure sealant (Kids E-dental LLP, India)   NANO-SILVER RESIN BASED PIT AND FISSURE SEALANT (Kids E-dental LLP, India) study period 6-8 months 
Comparator Agent  Fissure-FX Pit and fissure sealant (Voco, Germany)  MICROFILLED PIT AND FISSURE SEALANT (Voco, Germany) study period 6-8 months 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Healthy children with deep and retentive pits and fissures in permanent mandibular molars willing to participate will be included.  
 
ExclusionCriteria 
Details  Patients who are medically compromised, children with developmental defects/hypoplastic molars or caries affected teeth, teeth with restorations or partially retained sealant restorations, and partially erupted teeth will be excluded.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
sealant retention on tooth  6 months  
 
Secondary Outcome  
Outcome  TimePoints 
retention rate, marginal integrity of sealants and presence of caries in sealing deep pits and fissures in posterior teeth  3 months and 6 months 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   01/07/2023 
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="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

To compare and evaluate the clinical efficiency of two pit and fissure sealants (Microfilled and Nanofilled based) on Permanent mandibular molars in 6-12 year old children.

 

Since, the application of nanomaterials and functional fillers in dentistry has evolved due to the development of nanotechnology. There is a wide range of microfilled pit and fissure sealants and recently introduced nanofilled pit and fissure sealants available in the market, however, currently, there is limited availability of nano based dental sealants in India. Thus, a dire need arises for development and applicability of an Indian based nano technology based dental sealant. E-pit and Fissure sealant (Kids e- dental, LLP, India), newer silver containing nano resin based dental sealant. It mainly consists of UDMA resin with micronized GIC and silver, thereby making this newer dental product suitable for sealing pits and fissures, antimicrobial action, caries arrest and remineralisation. The newer product has received necessary regulatory body’s approval and free market sale certificate respectively.

 

 Keeping in mind the sample attrition, a  total of 144 (72 each )  mandibular permanent first molar teeth with stained/ deep pits and fissures will be selected in healthy children aged 6-12 years reporting to the Department of Paedodontics and Preventive Dentistry. Patients who are medically compromised, children with developmental defects/hypoplastic molars or caries affected teeth, teeth with restorations or partially retained sealant restorations, and partially erupted teeth will be excluded.

Written informed consent will be obtained from parents of all children participating in the study. Ethical clearance to conduct the study was obtained from the Institutional Review Board of Sudha Rustagi College of Dental Sciences and Research, Faridabad. A split mouth type of study will be designed, in which each side of the mouth will be assigned to a test agent; Group I- Fissurit FX fissure sealant (Voco, Germany) and; Group II- E-sealant using a coin toss method.

All the sealants will be placed in a dental clinic setting by a single operator working with proper illumination. Isolation will be carried out using a rubber dam with adequate suctioning to remove saliva from the operating field. A slurry of pumice and a rotating pointed bristle brush at slow speed will be used to clean the teeth and then rinsed  and air dried thoroughly. Etchant containing 37% phosphoric acid will be applied to the pits and fissures extending 1/3rd of the cuspal inclines for 30 seconds, washed thoroughly, and dried. After Dull frosty white appearance of the enamel. Fissure sealant will be gradually applied and flown along the fissures into the probe. The sealant will be immediately light cured after their placement by a 20 second exposure using light curing unit as per the manufacturer’s instructions. The sealed teeth will be checked for high points with articulating paper. Excess material will be removed using a small round finishing bur at a low speed. Patients will be informed not to eat or consume any fluids or eat for 30 minutes after the sealant placement. The entire procedure will be cross-checked by co-investigator to avoid any procedural errors and to ensure adequate sealing of teeth. The second examiner will be unaware of the different groups to avoid any bias. The sealants will be applied only once at the beginning of the study. Repair or replacement of insufficient sealants will not be attempted during the follow-up period. The sealed teeth will be evaluated clinically by co-investigators at 3 and, 6 months of interval using modified USPHS criteria.

 
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