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

Phase 2

Not yet recruiting

• Conditions: Carious Primary; Carious Anteriors
• Interventions: Biological: Injectable composite resin restoration; Biological: packable composite

• Registration Number: NCT06991582
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-04
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study Start: 2025-05-28
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Primary Completion: 2026-02-28
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injectable composite	Injectable composite resin restoration	Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan)
Packable Composite	packable composite	Packable Composite Beautifil II (Shofu INC., Koyoto, Japan)

Primary Outcome Measures

Name	Time	Method
Direct Clinical Assessment of Restoration	through study completion, on average of 1 year	Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Gross Fracture Measuring Device: Visual Inspection; Measuring unit: Alpha (A) Restoration is intact and fully retained. Bravo (B) Restoration is partially retained with some portion of the restoration still intact.; Charlie (C) Restoration is completely missing.

Secondary Outcome Measures

Name	Time	Method
Parents' patient Satisfaction	immediately after the intervention/procedure	Measuring Device: Questionnaire Measuring unit: Binary (yes or No)
Chair side time	immediately after the intervention/procedure	Measuring Device: Stopwatch Measuring unit: Minutes
Plaque accumulation	through study completion, on average of 1 year	Measuring 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.

Trial Locations

Locations (1)

Pediatric Dentistry Department, Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt