Clinical Efficiency of Bioactive Pit and Fissure Sealant
NCT ID: NCT06493942
Last Updated: 2024-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-08-01
2025-09-30
Brief Summary
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Detailed Description
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With no enough evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it isd beneficial to evaluate the newly introduced material using a randomized clinical trial to test the null hypothesis that bioactive resin pit and fissure sealant will have the same clinical performance as flouride releasing filled resin based pit and fissure sealant in susceptible fissures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Control group (A)
Fluoride releasing filled resin based pit and fissure sealant using UltraSeal XT™ plus by Ultradent
UltraSeal XT™ plus by Ultradent
UltraSeal XT plus is a 58%-filled resin fluoride-releasing sealant. It is strong and has high wear resistant
Interventional group (B)
Bioactive pit and fissure sealant using BioCoat® by Premier®
BioCoat® by Premier®
BioCoat is a 56% filled resin formula that provides added strength and excellent long-term resistance to wear ؤomparable to flowable composites.
Interventions
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BioCoat® by Premier®
BioCoat is a 56% filled resin formula that provides added strength and excellent long-term resistance to wear ؤomparable to flowable composites.
UltraSeal XT™ plus by Ultradent
UltraSeal XT plus is a 58%-filled resin fluoride-releasing sealant. It is strong and has high wear resistant
Eligibility Criteria
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Inclusion Criteria
* Co-operative patients approving to part- icipate in the trial.
* Good oral hygiene.
* Caries susceptible occlusal pits and fissures.
* Intact contact with opposing teeth.
* Teeth with no previous restorations in other surfaces.
Exclusion Criteria
* patients have allergic history concerning methacrylate.
* patients with rampant caries, xerostomia, evidence of severe bruxism, clenching, or tempromandibular joint disorders
* participants who show lack of compliance.
* Carious pits and fissures.
* Developmental tooth defect.
* Partially erupted teeth
* Periapical pathology or signs of pulpal pathology.
* Tooth hypersensitivity.
* Heavy occlusion and occlusal contacts.
6 Years
10 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Samaa Salah Eldin Abd Elfattah
Assistant lecturer in pediatric dentistry department, faculty of Dentistry
Central Contacts
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Other Identifiers
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BPFS
Identifier Type: -
Identifier Source: org_study_id
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