18-Month Clinical Evaluation of Self-Adhesive Flowable Gi... | NCT06956651

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

NCT06956651

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

May 18, 2025Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Occlusal Caries

Interventions

FIT SA
Beautifil Flow Plus F00

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2025Estimated

Primary Completion Date

Apr 2027Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Apr 25, 2025

First Submission Date that Met QC Criteria

May 1, 2025

First Posted Date

May 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2025

Last Update Posted Date

May 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Beautifil Flow Plus X F00	Active Comparator	Conventional flowable giomer restorative material	Other: Beautifil Flow Plus F00
FIT SA	Experimental	Self Adhesive Flowable giomer restoration	Other: FIT SA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FIT SA	Other	Self Adhesive Flowable giomer restorative material	FIT SA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rana Ayman, PhD degree	Contact	+201226000747		rana.ayman@dentistry.cu.edu.eg

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000621145	Beautifil Flow Plus F00

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided