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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Carious Primary; Carious Anteriors
• Intervention / Treatment: Biological: Injectable composite resin restoration; Biological: packable composite

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bassant Mohamed ElMesbahy; Phone Number: +201127132944; Email: bassant.elmesbahy@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Pediatric Dentistry Department, Faculty of Dentistry, Cairo University
    • Contact: Lecturer; Phone Number: +201111511145; Email: rasha.adel@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injectable composite; Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan)	Biological: Injectable composite resin restoration; Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan)
Active Comparator: Packable Composite; Packable Composite Beautifil II (Shofu INC., Koyoto, Japan)	Biological: packable composite; Packable Composite Beautifil II (Shofu INC., Koyoto, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 28, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: May 4, 2025
• First Submitted That Met QC Criteria: May 18, 2025
• First Posted (Actual): May 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 14422023595700

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No