Clinical Evaluation of New Self-adhesive Flowable Composite Restorative Material With Bioactive Giomer Technology for Restoration of Occlusal Lesions Over 18 Months

Cairo University (CU)

Status: Begins enrollment in 3 months

Conditions: Occlusal Caries

Treatments: Other: Beautifil Flow Plus F00; Other: FIT SA

Study type: Interventional

Funder types: Other

Identifiers

NCT06956651

13579

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Beautifil Flow Plus X F00

Active Comparator group

Description:

Conventional flowable giomer restorative material

Treatment:

Other: Beautifil Flow Plus F00

FIT SA

Experimental group

Description:

Self Adhesive Flowable giomer restoration

Treatment:

Other: FIT SA