| CTRI Number |
CTRI/2026/02/103116 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on the Strength and Color Changes of Sealants in childrens Teeth |
|
Scientific Title of Study
|
Comparative Assessment of Retention and Discoloration of Pit and Fissure Sealants in Children - In vivo 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 |
Rasika Pavan Chandak |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
saveetha dental college and hospital ,162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
07038376379 |
| Fax |
|
| Email |
152411004.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rasika Pavan Chandak |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
07038376379 |
| Fax |
|
| Email |
152411004.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Rasika Pavan Chandak |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
saveetha dental college and hospital , 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
07038376379 |
| Fax |
|
| Email |
152411004.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospital |
|
|
Primary Sponsor
|
| Name |
saveetha dental college and hospital |
| Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrRasika Pavan Chandak |
Saveetha dental college and hospital , SIMATS University |
clinuc 28, department of pediatric and preventive dentistry , 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Thiruvallur
TAMIL NADU |
07038376379
152411004.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| saveetha dental college institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- Tooth 16 PF Seal without bonding agent
Group 2 - Tooth 26 PF Seal with bonding agent
Group 3 -Tooth 36 protec without bonding agent
Group 4:Tooth 46 protec with bonding agent |
Each child will receive sealants on all four permanent first molars as follows:
Tooth 16 – PF Seal without bonding agent
Tooth 26 – PF Seal with bonding agent
Tooth 36 – Clinpro without bonding agent
Tooth 46 – Clinpro with bonding agent
Dosage/Duration:
Single application at baseline
Clinical evaluation at baseline,3,6 months |
| Comparator Agent |
PF Seal with bonding vs. PF Seal without bonding
protec with bonding vs. protec without bonding |
PF Seal with bonding vs. PF Seal without bonding
protec with bonding vs. protec without bonding |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 7–15 years with mixed dentition.
Presence of all four fully/partially erupted permanent first molars suitable for sealant placement.
Molars with deep pits and fissures or ICDAS 0–2 non-cavitated lesions, but without cavitation or restorations.
Clinically and radiographically sound teeth – vital, asymptomatic, and free from proximal dentinal caries.
Medically healthy, cooperative children with parental consent and willingness for follow-up visits. |
|
| ExclusionCriteria |
| Details |
Children with systemic illnesses, special healthcare needs, or developmental enamel/dentin defects (e.g., MIH, fluorosis).
Permanent first molars with cavitated caries, restorations, hypoplasia, or previous sealant application.
Teeth with pulpal symptoms, periapical pathology, or radiographic evidence of dentinal/proximal caries.
Children unable to maintain adequate isolation or moisture control during sealant placement.
Uncooperative children or those without parental consent/follow-up compliance. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Retention rate of pit and fissure sealants on all four permanent first molars, assessed at periodic intervals (3,6 months) using standardized retention criteria (fully retained, partially lost, completely lost).
Discoloration of sealants, evaluated clinically by visual comparison with baseline shade (using a standardized shade guide or scoring system) at the same follow-up intervals. |
3,6 , 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Marginal integrity and surface wear of the sealants, evaluated clinically using modified USPHS/FDI criteria at each follow-up.
Caries incidence on sealed occlusal surfaces, assessed by ICDAS codes and radiographic confirmation when needed.
Marginal discoloration and patient acceptability, recorded using a standardized visual scoring system and simple parent/child feedback. |
3,6 , 12 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/02/2026 |
| 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 Yet Recruiting |
| 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
|
This in vivo study aims to evaluate the retention and discoloration of different pit and fissure sealants applied on all four permanent first molars in children aged 7–15 years. A total of eligible participants will be recruited based on strict inclusion and exclusion criteria, ensuring teeth are sound, vital, and free of cavitated lesions or previous restorations. Sealants will be placed under standardized clinical conditions and evaluated at predetermined time points (3, 6 months ). |