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

NCT06991582 | Not Yet Recruiting Phase 2

• 1 other identifier: 14422023595700
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carious Primary; Carious Anteriors

Outcome Measures

Primary Outcomes (7)

• 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.

  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

  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.

  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)

  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.

  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.

  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.

  through study completion, on average of 1 year

Secondary Outcomes (3)

• Parents' patient Satisfaction

  immediately after the intervention/procedure

• Chair side time

  immediately after the intervention/procedure

• Plaque accumulation

  through study completion, on average of 1 year

Study Arms (2)

Injectable composite

EXPERIMENTAL

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

Biological: Injectable composite resin restoration

Packable Composite

ACTIVE COMPARATOR

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

Biological: packable composite

Interventions

Injectable composite resin restoration BIOLOGICAL

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

Injectable composite

packable composite BIOLOGICAL

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

Packable Composite

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Pediatric Dentistry Department, Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Central Study Contacts

Bassant Mohamed ElMesbahy

CONTACT

+201127132944; bassant.elmesbahy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 28, 2025
• Study Start: May 28, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 30, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

EG (1)