18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Conservative Occlusal Restorations
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The study compares two restorative materials to restore occlusal decay, offering the patients high-strength, high-durability restorations with antibacterial properties.
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 Sep 2025
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
April 25, 2025
CompletedFirst Posted
Study publicly available on registry
May 4, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
May 18, 2025
May 1, 2025
1.6 years
April 25, 2025
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical performance
Clinical performance using the Modified United States Public Health Service criteria, values: alpha (upper value - better outcome), charlie (lower value- worse outcome).
18 months
Study Arms (2)
Beautifil Flow Plus X F00
ACTIVE COMPARATORConventional flowable giomer restorative material
FIT SA
EXPERIMENTALSelf Adhesive Flowable giomer restoration
Interventions
Eligibility Criteria
You may qualify if:
- Posterior vital tooth with Class I caries.
You may not qualify if:
- Teeth with clinical symptoms of pulpitis, such as spontaneous pain.
- Pain or sensitivity to pressure.
- Non-vital teeth.
- Fractured or cracked teeth.
- Endodontically treated teeth.
- Periodontally affected teeth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
April 25, 2025
First Posted
May 4, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
May 18, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
There is no available evidence assessing FIT SA restorative material in occlusal cavity restoration. Therefore, the study aims to provide insights into its clinical performance regarding functional and aesthetic aspects.