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CTRI Number  CTRI/2025/08/093465 [Registered on: 22/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized Factorial Trial 
Public Title of Study   Evaluation of sealant placement using vibration, tooth preparation using bur and conventional method - 1 year follow up 
Scientific Title of Study   Clinical evaluation of effect of sonic vibration and fissurotomy on retention and marginal integrity of pit and fissure sealants reinforced with silver nanoparticles - A 1yr follow up 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  Darshana S 
Designation  Postgraduate  
Affiliation  SRM Ramapuram 
Address  Department of paediatric and preventive dentistry,Dental, Room no 8,SRM Dental college, Bharathi salai, Ramapuram, Chennai, Tamilnadu 600089

Chennai
TAMIL NADU
600089
India 
Phone  9710528076  
Fax    
Email  ds8919@srmist.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shankar.P 
Designation  Reader 
Affiliation  SRM Ramapuram 
Address  Department of paediatric and preventive dentistry,Dental, Room no 8,SRM Dental college, Bharathi salai, Ramapuram, Chennai, Tamilnadu 600089

Chennai
TAMIL NADU
600089
India 
Phone  9884585808  
Fax    
Email  shankarp1@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Darshana S 
Designation  Postgraduate  
Affiliation  SRM Ramapuram 
Address  Department of paediatric and preventive dentistry,Dental, Room no 8,SRM Dental college, Bharathi salai, Ramapuram, Chennai, Tamilnadu 600089

Chennai
TAMIL NADU
600089
India 
Phone  9710528076  
Fax    
Email  ds8919@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Dental College, Bharathi salai, Ramapuram, Tamilnadu, 600089 
 
Primary Sponsor  
Name  Darshana S 
Address  SRM Dental college, Bharathi salai, Ramapuram, tamilnadu 
Type of Sponsor  Other [Deemed university] 
 
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 
Darshana S  SRM Dental College  Department of paediatric and preventive dentistry,Dental, Room no 8,SRM Dental college, Bharathi salai, Ramapuram, Chennai, Tamilnadu 600089
Chennai
TAMIL NADU 
9710528076

ds8919@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB, SRM Dental college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Deep pits and fissures in permanent 1st molar 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional method of sealant application  comparing fissurotomy and sonic vibration with conventional method of sealant application 
Intervention  conventional with sonic vibration, fissurotomy with sonic vibration, fissurotomy  Application of pit and fissure sealant with fissurotomy and sonic vibration and follow up for 1 year 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1) Children aged between 6 to 9 years falling under Frankl’s behavior rating scale criteria 3 and 4.
2) All four permanent molars erupted.
3) Molars with no developmental abnormalities.
4) Teeth with deep pits and fissures.
5) Teeth with ICDAS score 0
6) Children whose parents gave consent to participate in the study.
 
 
ExclusionCriteria 
Details  1) Teeth with sealants and fillings.
2) Teeth with caries.
3) Children with stain on grooves.
4) Children falling under Frankl’s behavior rating scale criteria 1 and 2.
5) Teeth with developmental abnormalities
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the effect of sonic vibration and fissurotomy on retention and marginal integrity of silver nanoparticle reinforced pit and fissure sealants.
 
3 moths, 6 months, 9 months, 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess & compare the retention of pit & fissure sealant using sonic vibration, fissurotomy, fissurotomy along with vibration & conventional technique.

To assess & compare the marginal integrity of pit & fissure sealant using sonic vibration, fissurotomy, fissurotomy along with vibration & conventional technique.
 
3 months, 6 months, 9 months, 12 months 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   02/09/2025 
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="1"
Months="0"
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  

The incidence of dental caries in India affects around 60-80% of children. Pit and fissure sealants reduce this by 70-90%, effectively sealing vulnerable areas on teeth, preventing food particles and bacteria from accumulating and causing decay, thereby promoting better oral health. However, the success of sealants depends significantly on their ability to adhere to enamel surfaces and maintain marginal integrity over time. Various techniques and materials have been explored to enhance sealant retention and effectiveness. This study focuses on evaluating the impact of sonic vibration and fissurotomy on the retention and marginal integrity of pit and fissure sealants, specifically those reinforced with silver nanoparticles.Sample Size and Study Design: The study will involve a total of 176 permanent first molars in children aged 6-9 years. A randomized controlled split-mouth design will be employed, dividing the teeth into four groups:

  1. Group A (Control): In this group, the conventional method of sealant application will be used.
  2. Group B: Sealants will be applied with the assistance of sonic vibration using a Compo-vibes device.
  3. Group C: Enamel preparation will involve the use of a Micro STF fissurotomy bur followed by conventional sealant application.
  4. Group D: Enamel preparation with a Micro STF fissurotomy bur will be combined with sealant application assisted by sonic vibration.


Materials and Armamentarium: The study will utilize standard dental examination tools such as mouth mirrors, tweezers, probes, and explorers for clinical assessments. A rubber dam isolation kit will ensure effective isolation during procedures. Enamel preparation will be carried out using a 35% phosphoric acid etchant, and sealants used will be specifically e-Pit and fissure sealant reinforced with silver nanoparticles. Curing of sealants will be conducted with a light curing unit featuring appropriate wavelength and intensity. Specialized instruments like the Compo-vibes composite modeling instrument and Micro STF fissurotomy bur will be employed for sonic vibration and fissurotomy procedures, respectively.


Procedure: Each group will undergo a specific sequence of procedures tailored to their assigned technique:


  • Group A (Control): The teeth will be etched with 35% phosphoric acid, followed by application and curing of the e-Pit and fissure sealant.
  • Group B: Enamel etching will be performed with simultaneous sonic vibration using the Compo-vibes device, followed by sealant application and curing.
  • Group C: Enamel preparation will involve the use of the Micro STF fissurotomy bur to mechanically widen fissures, followed by standard etching, sealant application, and curing.
  • Group D: Similar to Group C, enamel preparation with the Micro STF fissurotomy bur will be combined with etching assisted by sonic vibration using the Compo-vibes device, followed by sealant application and curing.



Evaluation Criteria: The modified United States Public Health Service (USPHS) Ryge criteria will be employed to assess:

  • Sealant retention: This criterion evaluates partial or total loss of sealant over specified time intervals (3, 6, 9, and 12 months).
  • Marginal integrity: This criterion assesses the quality of sealant adaptation to enamel margins, ensuring effective coverage and sealing of fissures.
 
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