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

Clinical Assessment of Injectable Composite Versus Packable Composite in Treatment of Carious Primary Anterior Teeth: A Randomized Clinical Trial

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06991582
Enrollment
16
Registered
2025-05-28
Start date
2025-05-28
Completion date
2026-03-30
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carious Anteriors, Carious Primary

Brief summary

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

Interventions

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

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Direct Clinical Assessment of Restorationthrough study completion, on average of 1 yearModified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Marginal integrity Measuring Device: Explorer Measuring unit: Alpha (A) There is no visible evidence of ditching along the margin of the restoration. Bravo (B) There is visible evidence of ditching along the margin of the restoration, it is not extending to the dentino-enamel junction. Charlie (C) There is dentin or base is exposed along the margin of the restoration. Delta (D) The restoration is mobile, fractured, or missing.

Secondary

MeasureTime frameDescription
Parents' patient Satisfactionimmediately after the intervention/procedureMeasuring Device: Questionnaire Measuring unit: Binary (yes or No)
Chair side timeimmediately after the intervention/procedureMeasuring Device: Stopwatch Measuring unit: Minutes
Plaque accumulationthrough study completion, on average of 1 yearMeasuring Device: Plaque index Score by Probe Measuring unit: 0 : No plaque 1. : A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only by using the probe on the tooth surface. 2. : Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. 3. : Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

Countries

Egypt

Contacts

Primary ContactBassant Mohamed ElMesbahy
bassant.elmesbahy@dentistry.cu.edu.eg+201127132944

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026