18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial
1 other identifier
interventional
34
0 countries
N/A
Brief Summary
The material under investigation will offer the patient a high strength and high durability restoration with the advantage of having anti-bacterial 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 19, 2025
CompletedFirst Posted
Study publicly available on registry
April 27, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
April 27, 2025
April 1, 2025
1.4 years
April 19, 2025
April 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Performance
Clinical Performance using Modified USPHS criteria
18 months
Study Arms (2)
Beautifil Flow Plus F00
ACTIVE COMPARATORConventional flowable giomer restorative material
FIT SA
EXPERIMENTALSelf adhesive flowable giomer restorative material
Interventions
Conventional flowable giomer restorative material
Eligibility Criteria
You may qualify if:
- Cervical carious lesions in anterior teeth and premolars
- Small to moderate class V carious lesion (ICDAS 3 \& 4).
- Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth
You may not qualify if:
- Cervical carious lesions in molars.
- Deep carious defects (close to pulp, less than 1 mm distance).
- Teeth with clinical symptoms of pulpitis such as spontaneous 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
- master holder
Study Record Dates
First Submitted
April 19, 2025
First Posted
April 27, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
April 27, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions