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18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Conservative Occlusal Restorations

18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Conservative Occlusal Restorations: A Randomized Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06956651
Enrollment
40
Registered
2025-05-04
Start date
2025-09-30
Completion date
2027-04-30
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occlusal Caries

Keywords

self adhesive giomer, class I, clinical performance, Beautifil Flow, FIT SA, USPHS Criteria

Brief summary

The study compares two restorative materials to restore occlusal decay, offering the patients high-strength, high-durability restorations with antibacterial properties.

Detailed description

There is no available evidence discussing the FIT SA restorative material in the restoration of occlusal lesions. This study aims to provide valuable insights into the clinical performance of this restorative material compared to the gold standard.

Interventions

OTHERFIT SA

Self Adhesive Flowable giomer restorative material

Conventional Flowable giomer composite

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Posterior vital tooth with Class I caries.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical performance18 monthsClinical performance using the Modified United States Public Health Service criteria, values: alpha (upper value - better outcome), charlie (lower value- worse outcome).

Contacts

Primary ContactRana Ayman, PhD degree
rana.ayman@dentistry.cu.edu.eg+201226000747

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026