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

NCT ID: NCT06956651

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Occlusal Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Beautifil Flow Plus X F00

Conventional flowable giomer restorative material

Group Type ACTIVE_COMPARATOR

Beautifil Flow Plus F00

Intervention Type OTHER

Conventional Flowable giomer composite

FIT SA

Self Adhesive Flowable giomer restoration

Group Type EXPERIMENTAL

FIT SA

Intervention Type OTHER

Self Adhesive Flowable giomer restorative material

Interventions

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FIT SA

Self Adhesive Flowable giomer restorative material

Intervention Type OTHER

Beautifil Flow Plus F00

Conventional Flowable giomer composite

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Rana Ayman Kamal

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Rana Ayman, PhD degree

Role: CONTACT

+201226000747

Other Identifiers

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13579

Identifier Type: -

Identifier Source: org_study_id

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