18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial

NCT ID: NCT06946134

Last Updated: 2025-04-27

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-02-28

Brief Summary

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The material under investigation will offer the patient a high strength and high durability restoration with the advantage of having anti-bacterial properties.

Detailed Description

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There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions.

Conditions

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Cervical 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 F00

Conventional flowable giomer restorative material

Group Type ACTIVE_COMPARATOR

Beautifil Flow Plus F00

Intervention Type OTHER

Conventional flowable giomer restorative material

FIT SA

Self adhesive flowable giomer restorative material

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 restorative material

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Cervical carious lesions in anterior teeth and premolars
2. Small to moderate class V carious lesion (ICDAS 3 \& 4).
3. Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.
4. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Exclusion Criteria

1. Cervical carious lesions in molars.
2. Deep carious defects (close to pulp, less than 1 mm distance).
3. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
4. Non-vital teeth, Fractured or cracked teeth.
5. Endodontically treated teeth.
6. 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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Amera Nabel

master holder

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amira Nabil El-Gaaly, PhD degree

Role: CONTACT

00201099872098

Related Links

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Other Identifiers

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CairoU PhD protocol for Amira

Identifier Type: -

Identifier Source: org_study_id

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