Clinical Evaluation Of Retention Of Pit and Fissure Sealant With and Without SDF/KI Pre-treatment in 6-8Year Old Children – A Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Better retention of pit and fissure sealant pre-treated with SDF/KI at baseline, after 3 months and 6 months follow up
Study Overview
Brief Summary
Objective of the study is:
a) Toevaluate the retention ability of pit and fissure sealant (Ultraseal XT hydro)with SDF/KI pre-treatment in 6-8year old children on primary second molars andfirst permanent molars clinically at baseline, after 3 months and 6 monthsfollow up
b) Toevaluate the retention ability of pit and fissure sealant (Ultraseal XT hydro)without pre-treatment with SDF/KI in 6-8year old children on primary secondmolars and first permanent molars clinically at baseline, after 3months and 6months follow up
c) Tocompare the retention ability of pit and fissure sealant (Ultraseal XT hydro)pre-treated with and without SDF/KI
RESEARCHHYPOTHESIS
Pre-treatment with SDF/KI increases theretention ability of Pit and fissure Sealant (Ultraseal XT hydro) at variousintervals of follow up
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 6.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Teeth indicated for pit and fissure sealants 2)ICDAS codes 0, 1 and 2 3)Absence of restorations or prior sealants on the teeth under study 4)Absence of cavitated carious lesions.
Exclusion Criteria
- •Children with special health care needs 2)Teeth with cavitated dentinal caries.
Outcomes
Primary Outcomes
Better retention of pit and fissure sealant pre-treated with SDF/KI at baseline, after 3 months and 6 months follow up
Time Frame: At baseline
Secondary Outcomes
- Prevention of Pit and Fissure caries and better retention of pit and fissure sealant pre-treated with and without SDF/KI(After 3 months)