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