NCT05127343UnknownNot Applicable
One Year Clinical Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants Among Adolescents: A Randomized Clinical Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Retention rate
Study Overview
Brief Summary
The aim of the study is to clinically evaluate the retention and caries formation of hydrophilic fissure sealants among adolescents after one year.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
- •Healthy patients with no history of previous systematic diseases that can affect their oral health and sealant application.
- •Cooperative patients who will allow the clinical applications
Exclusion Criteria
- •Uncooperative behaviour limiting the use of sealants throughout the procedure.
- •Patients with history of medical diseases, drug therapies or any other serious relevant problem.
- •Patients with well coalesced pits and fissures
- •Patients allergic to sealant material
- •Patients who underwent orthodontic treatment.
Arms & Interventions
Resin based sealant (Ultraseal XT Hydro)
Active Comparator
Intervention: Sealing deep pits and fissures (Procedure)
Glass ionomer based sealant (Fugi Triage)
Active Comparator
Intervention: Sealing deep pits and fissures (Procedure)
Outcomes
Primary Outcomes
Retention rate
Time Frame: Change from baseline at 3, 6, 12 months
* Full retention (FR): The material is fully present on the occlusal surfaces * Partially lost (PL): The material is present, but as a result of either wear or loss of the material, part of the previously sealed fissure, was exposed. * Totally lost (TL): No trace of the material to be detected on the surface
Secondary Outcomes
- Caries formation(Change from baseline at 3, 6, 12 months)
Investigators
Ghada Mohamed El-Amir Hashim Sediek
Master's Degree student- Faculty of Dentistry
Cairo University
Study Sites (1)
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