Clinical Assessment of Injectable Composite Versus Packable Composite in Treatment of Carious Primary Anterior Teeth

NCT ID: NCT06991582

Last Updated: 2025-05-28

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

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2026-03-30

Brief Summary

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The aim of this study is to evaluate the clinical success of injectable composite versus packable composite in restoration of primary anteriors.

Detailed Description

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Conditions

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Carious Primary Carious Anteriors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be recruited from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry Cairo University. Patients will be carefully assessed for eligibility to participate in our study then a full explanation of the nature of our experiment will be provided for parents or guardian before obtaining the informed consent from them.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Injectable composite

Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan)

Group Type EXPERIMENTAL

Injectable composite resin restoration

Intervention Type BIOLOGICAL

Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan)

Packable Composite

Packable Composite Beautifil II (Shofu INC., Koyoto, Japan)

Group Type ACTIVE_COMPARATOR

packable composite

Intervention Type BIOLOGICAL

Packable Composite Beautifil II (Shofu INC., Koyoto, Japan)

Interventions

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Injectable composite resin restoration

Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan)

Intervention Type BIOLOGICAL

packable composite

Packable Composite Beautifil II (Shofu INC., Koyoto, Japan)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Children with caries in primary anterior teeth.
* Caries involving class III, IV, V or multisurface caries
* Restorable anterior teeth
* Pre operative Radiograph showing at least half of the root is not resorbed).

Exclusion Criteria

* Badly decayed non restorable anterior teeth
* Signs and symptoms of root resorption (more than half the root is resorbed)
* Presence of bony resorption
* Presence of pathological root resorption
* Tooth Mobility
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Bassant Mohamed Elmesbahy

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pediatric Dentistry Department, Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Bassant Mohamed ElMesbahy

Role: CONTACT

+201127132944

Facility Contacts

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Lecturer

Role: primary

+201111511145

Other Identifiers

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14422023595700

Identifier Type: -

Identifier Source: org_study_id

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