Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants
One Year Clinical Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants Among Adolescents: A Randomized Clinical Trial
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedNovember 19, 2021
November 1, 2021
5 months
November 12, 2021
November 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention rate
* 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
Change from baseline at 3, 6, 12 months
Secondary Outcomes (1)
Caries formation
Change from baseline at 3, 6, 12 months
Study Arms (2)
Resin based sealant (Ultraseal XT Hydro)
ACTIVE COMPARATORGlass ionomer based sealant (Fugi Triage)
ACTIVE COMPARATORInterventions
Application of the pit and fissure sealant
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of dentistry
Cairo, 11331, Egypt
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Iman I ElSayad, Professor
Cairo University
- STUDY DIRECTOR
Heba Helal
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master's Degree student- Faculty of Dentistry
Study Record Dates
First Submitted
November 12, 2021
First Posted
November 19, 2021
Study Start
February 1, 2022
Primary Completion
July 1, 2022
Study Completion
February 1, 2023
Last Updated
November 19, 2021
Record last verified: 2021-11