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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Occlusal Caries
• Intervention / Treatment: Other: Beautifil Flow Plus F00; Other: FIT SA

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana Ayman, PhD degree; Phone Number: +201226000747; Email: rana.ayman@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Beautifil Flow Plus X F00; Conventional flowable giomer restorative material	Other: Beautifil Flow Plus F00; Conventional Flowable giomer composite
Experimental: FIT SA; Self Adhesive Flowable giomer restoration	Other: FIT SA; Self Adhesive Flowable giomer restorative material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: clinical performance; class I; FIT SA; self adhesive giomer; Beautifil Flow; USPHS Criteria
• Other Study ID Numbers: 13579

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No