A Phase 2 interventional study of Injectable composite resin restoration and packable composite in Carious Primary and Carious Anteriors, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Cairo University · Phase 2, Interventional, and Treatment
The aim of this study is to evaluate the clinical success of injectable composite versus packable composite in restoration of primary anteriors.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan)
Biological: Injectable composite resin restoration
Packable Composite Beautifil II (Shofu INC., Koyoto, Japan)
Biological: packable composite
Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan)
Packable Composite Beautifil II (Shofu INC., Koyoto, Japan)
Direct Clinical Assessment of Restoration
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.
Time frame: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
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
Time frame: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
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.
Time frame: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
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)
Time frame: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
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.
Time frame: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
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.
Time frame: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
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.
Time frame: through study completion, on average of 1 year
Parents' patient Satisfaction
Measuring Device: Questionnaire Measuring unit: Binary (yes or No)
Time frame: immediately after the intervention/procedure
Chair side time
Measuring Device: Stopwatch Measuring unit: Minutes
Time frame: immediately after the intervention/procedure
Plaque accumulation
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.
Time frame: through study completion, on average of 1 year
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Cairo University