Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT07262502
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Clinical Success of Hydrophilic Fissure Sealants
Sponsor:
Afyonkarahisar Health Sciences University
Organization:
Study Overview
Official Title:
EVALUATION OF THE CLINICAL SUCCESS OF A HYDROPHILIC FISSURE SEALANT APPLIED TO LOWER PERMANENT MOLARS UNDER DRY AND WET CONDITIONS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
The study group will consist of children aged 7-11 years who are systemically healthy and who apply to the Pediatric Dentistry Clinic of the Faculty of Dentistry, Afyonkarahisar Health Sciences University for routine dental treatment.
In the study, fissure sealants will be applied to the first molars with opposing deep pits and fissures in the same jaw.
The study will involve the application of fissure sealants to the first molars with opposing deep pits and fissures in the same jaw.
It was decided to include a total of 500 teeth from 250 patients in the study, with 250 teeth in each group.
The occlusal surface of each tooth will be dried and etched with 37% phosphoric acid (Eco-Etch; Ivoclar Vivadent, Inc. Schaan, Liechtenstein) and thoroughly rinsed for 30 seconds.
If saliva contamination occurs, the surface will be etched again. The treated tooth will be air-dried for 3 seconds and the tooth in the opposing jaw for 15 seconds. Subsequently, the relevant fissure sealant (Pulpdent, Embrace Wetbond Pit and Fissure Sealant) will be applied to the occlusal surface of each tooth and cured for 20 seconds using a light-curing unit at an intensity of 500 mW/cm².
After restoration, articulation paper will be used to check for any high spots in the occlusion; if found, excess material will be removed using a finishing bur.
Clinical evaluations of marginal integrity, marginal color change, and retention after the liner is placed will be performed at 3, 6, 9, and 12 months using the World Health Organization probe according to the Ryge and Synder criteria.
In the study, fissure sealants will be applied to the first molars with opposing deep pits and fissures in the same jaw.
The study will involve the application of fissure sealants to the first molars with opposing deep pits and fissures in the same jaw.
It was decided to include a total of 500 teeth from 250 patients in the study, with 250 teeth in each group.
The occlusal surface of each tooth will be dried and etched with 37% phosphoric acid (Eco-Etch; Ivoclar Vivadent, Inc. Schaan, Liechtenstein) and thoroughly rinsed for 30 seconds.
If saliva contamination occurs, the surface will be etched again. The treated tooth will be air-dried for 3 seconds and the tooth in the opposing jaw for 15 seconds. Subsequently, the relevant fissure sealant (Pulpdent, Embrace Wetbond Pit and Fissure Sealant) will be applied to the occlusal surface of each tooth and cured for 20 seconds using a light-curing unit at an intensity of 500 mW/cm².
After restoration, articulation paper will be used to check for any high spots in the occlusion; if found, excess material will be removed using a finishing bur.
Clinical evaluations of marginal integrity, marginal color change, and retention after the liner is placed will be performed at 3, 6, 9, and 12 months using the World Health Organization probe according to the Ryge and Synder criteria.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: