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Not yet recruiting NCT06991582

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

Phase II Interventional Carious Primary Carious Anteriors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Injectable composite resin restoration, packable composite.
Who it may be relevant to
Registry conditions: Carious Primary, Carious Anteriors. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Direct Clinical Assessment of Restoration [Time frame: through study completion, on average of 1 year]
  • Direct Clinical Assessment of Restoration [Time frame: through study completion, on average of 1 year]
  • Direct Clinical Assessment of Restoration [Time frame: through study completion, on average of 1 year]
  • Direct Clinical Assessment of Restoration [Time frame: through study completion, on average of 1 year]
  • Direct Clinical Assessment of Restoration [Time frame: through study completion, on average of 1 year]
  • Direct Clinical Assessment of Restoration [Time frame: through study completion, on average of 1 year]
  • Direct Clinical Assessment of Restoration [Time frame: through study completion, on average of 1 year]
Secondary outcome measures (3)
  • Parents' patient Satisfaction [Time frame: immediately after the intervention/procedure]
  • Chair side time [Time frame: immediately after the intervention/procedure]
  • Plaque accumulation [Time frame: through study completion, on average of 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Pediatric Dentistry Department, Faculty of Dentistry, Cairo University — Cairo

Identifiers

NCT: NCT06991582 · 14422023595700

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗