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NCT Number: NCT06991582

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injectable composite resin restoration

Biological

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

packable composite

Biological

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

Primary outcomes

  1. Direct Clinical Assessment of Restoration

    Time frame: through study completion, on average of 1 year

    Modified 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.

  2. Direct Clinical Assessment of Restoration

    Time frame: through study completion, on average of 1 year

    Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Color Match Measuring Device: Visual Inspection

    Measuring unit:

    Alpha (A) The restoration appears to match the shade and translucency of adjacent tooth tissues.

    Bravo (B)The restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the normal range of tooth shades.

    Charlie (C)The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency

  3. Direct Clinical Assessment of Restoration

    Time frame: through study completion, on average of 1 year

    Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Cavo surface marginal discoloration Measuring Device: Visual Inspection

    Measuring unit:

    Alpha (A) There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure.

    Bravo (B) There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction.

    Charlie (C) There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.

  4. Direct Clinical Assessment of Restoration

    Time frame: through study completion, on average of 1 year

    Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Secondary Caries Measuring Device: Visual Inspection

    Measuring unit:

    Alpha (A) The restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B) There is visual evidence of dark keep discoloration adjacent to the restoration (but not directly associated with cavosurface margins)

  5. Direct Clinical Assessment of Restoration

    Time frame: through study completion, on average of 1 year

    Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Anatomic Contour Measuring Device: Visual Inspection and Explorer

    Measuring unit:

    Alpha (A) Visual inspection and explorer The restoration is a continuation of existing anatomic form or is slightly flattened. It may be overcontoured. When the side of the explorer is placed tangentially across the restoration, it does not touch two opposing cavosurface line angles at the same time.

    Bravo (B) A surface concavity is evident. When the side of the explorer is placed tangentially across the restoration, it does not touch two opposing cavosurface line angles at the same time, but the dentin or base is not exposed.

    Charlie (C) There is a loss of restorative substance such that a surface concavity is evident and the base and/or dentin is exposed.

  6. Direct Clinical Assessment of Restoration

    Time frame: through study completion, on average of 1 year

    Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Surface Texture Measuring Device: Explorer

    Measuring unit:

    Alpha (A) Explorer Surface texture similar to polished enamel as determined by means of a sharp explorer.

    Bravo (B) Explorer Surface texture gritty or similar to a surface subjects to a white stone or similar to a composite containing supramicron-sized particles.

    Charlie (C) Explorer Surface pitting is sufficiently coarse to inhibit the continuous movement of an explorer across the surface.

  7. Direct Clinical Assessment of Restoration

    Time frame: 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 outcomes

  1. Parents' patient Satisfaction

    Time frame: immediately after the intervention/procedure

    Measuring Device: Questionnaire Measuring unit: Binary (yes or No)

  2. Chair side time

    Time frame: immediately after the intervention/procedure

    Measuring Device: Stopwatch Measuring unit: Minutes

  3. Plaque accumulation

    Time frame: through study completion, on average of 1 year

    Measuring Device: Plaque index Score by Probe

    Measuring unit:

    0 : No plaque

    • : 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.
    • : Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
    • : Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

Study contacts

Contact information is provided by the study sponsor or research team.

Bassant Mohamed ElMesbahy

CONTACT

[email protected]

+201127132944

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.