Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05791682
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2022-11-12
Brief Title:
Comparative Clinical Evaluation of Pit and Fissure Sealants on Permanent First Molar Teeth in Children
Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Organization:
Postgraduate Institute of Dental Sciences Rohtak
Study Overview
Official Title:
Comparative Clinical Evaluation of Microfilled Resin Sealant Nanofilled Resin Sealant and Flowable Composite as Sealant With Unfilled Resin Sealant on Permanent First Molar Teeth in Children
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study was aimed to evaluate and compare clinical efficacy of the Microfilled resin sealant Nanofilled resin sealant Flowable composite as sealant with Unfilled resin sealant on first permanent molar in children at 9 months follow ups
Children age 7 to 10 with deep pits and fissures ICDAS 0-2 included in the study and study was Split mouth randomized controlled clinical trial
Sample size- Total number of 42 patients will be recruited in the study with 42 first permanent molars in each group
Methods-Patients were seated in supine position on the dental chair and cotton rolls will be applied for isolation The first permanent molar in each group was treated as follows
Group 1 -Intervention with Microfilled resin sealant Group 2- Intervention with Nanofilled resin sealant Group 3 -Intervention with Flowable composite as sealant Group 4 - Intervention with Unfilled resin sealant Patients and their parents were received instructions for daily brushing and oral hygiene maintenance Sealant clinical efficacy was evaluated at 3 6 and 9 month recall visit
OUTCOME MEASURES
1 Primary outcomes To evaluate sealant retention anticaries effect and marginal integration
2 Secondary outcomes to evaluate colour change and surface roughness of sealant
Children age 7 to 10 with deep pits and fissures ICDAS 0-2 included in the study and study was Split mouth randomized controlled clinical trial
Sample size- Total number of 42 patients will be recruited in the study with 42 first permanent molars in each group
Methods-Patients were seated in supine position on the dental chair and cotton rolls will be applied for isolation The first permanent molar in each group was treated as follows
Group 1 -Intervention with Microfilled resin sealant Group 2- Intervention with Nanofilled resin sealant Group 3 -Intervention with Flowable composite as sealant Group 4 - Intervention with Unfilled resin sealant Patients and their parents were received instructions for daily brushing and oral hygiene maintenance Sealant clinical efficacy was evaluated at 3 6 and 9 month recall visit
OUTCOME MEASURES
1 Primary outcomes To evaluate sealant retention anticaries effect and marginal integration
2 Secondary outcomes to evaluate colour change and surface roughness of sealant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None