Clinical and Radiographic Evaluation of Injectable Composite Versus Packable Composite in Restoring of Primary Molars

April 11, 2026 updated by: Eslam samy abdel monaem kalboush

Clinical and Radiographic Assessment of Injectable Composite Versus Packable Composite in the Restoration of Cavitated Primary Molars a Randomized Clinical Trial

This randomized clinical trial aims to compare the clinical and radiographic performance of injectable composite versus packable composite in restoring cavitated primary molars in children aged 4 to 8 years.

Study Purpose

To determine whether injectable composite performs as well as packable composite in Class II restorations in primary molars clinically and radiographically.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized clinical trial aims to compare the clinical and radiographic performance of injectable composite versus packable composite in restoring cavitated primary molars in children aged 4-8 years.

Study Purpose

To determine whether injectable composite performs as well packable composite in Class II restorations in primary molars.

Study Design

Type: Randomized clinical trial

Sample: 64 primary molars (32 per group)

Allocation: 1:1 using concealed envelopes

Group I (Experimental group): Injectable composite (Beautifil Flow Plus X F00, Shofu, Japan) Group II (Control group): Packable composite (Beautifil II LS, Shofu, Japan)

Follow-up: Clinical at 3, 6, 12 months

Radiographic at 0, 6, 12 months

Location: Pediatric Dentistry Clinic, Cairo University

Outcome Measures

Primary Outcome Clinical Performance (FDI Criteria):

Functional: marginal adaptation, fracture, proximal contact, occlusion, wear

Biological: caries at margins, hard tissue defects, sensitivity, pulp status

Esthetic: texture, staining, color match

Secondary Outcome Radiographic Performance:

Presence/absence of voids

Marginal integrity on bitewing radiographs

Rationale

Injectable composites may offer:

Better cavity adaptation

Easier handling

Shorter chair time (important in pediatric dentistry)

Packable composites offer:

Higher strength and wear resistance

The study investigates whether injectables can match or outperform packables clinically.

Hypothesis

Null hypothesis: There is no difference between injectable and packable composites in clinical and radiographic success.

Intervention The principal investigator ES will carry out all treatment procedures, and the patients will be randomly assigned to any of them.

For both groups:

  1. Informed consent from participating children parents.
  2. Baseline records photographs, percussion test, periapical radiograph and personal data collection (Appendix 1: Diagnostic chart).

  3. Diagnostic chart with personal, medical and dental history will be filled (Appendix 1:

    Diagnostic chart).

  4. Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of restorative material that will be used then writing the patient name and I.D. on it and will be opened after performing the cavity).
  5. Clinical examination will be performed to assess the clinical inclusion criteria.
  6. Preoperative and Postoperative photographs will be taken.
  7. The radiographic examination will be performed by taking a periapical x-ray using (bitewing technique) to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs.
  8. Administration of local anesthesia at the side of the affected tooth.
  9. Application of rubber dam for isolation, then caries removal procedure will be performed using a sterile round-end bur in a high-speed handpiece
  10. After cavity preparation, conditioning of the tooth will be done using 35% phosphoric acid for 30 seconds for enamel and 15 seconds for dentin. Then, after rinsing the acid etch with water for 10 seconds, bond will be applied to the tooth using a bond brush and then cured for 5 seconds.
  11. The restorative material will be placed in the cavity and will be cured for 20 seconds per increment for the intervention group and for 20 seconds for the control group (17).
  12. The last step is to finish and polish the restoration material with abrasive rubber tips using the KENDA C.G.I polishing system (Coltene, Switzerland) (
  13. Clinical assessment will be done after each visit using FDI criteria to assess the clinical performance of each restoration in the three domains (biological, functional and aesthetics) and radiographic assessment will be done for 0, 6, and 12 months using periapical bitewing x-ray.

Sample size calculation:

Data will be analyzed using Medcalc software, version 22 for Windows (MedCalc Software Ltd, Ostend, Belgium).

Categorical data will be described as frequency and percentage. Intergroup Comparisons between categorical variables will be performed using the chi-square test, while intragroup comparisons within each intervention will be performed using Cochran's Q test followed by pairwise multiple comparisons.

A p-value less than or equal to 0.05 will be considered statistically significant, and all tests will be two-tailed. Statistical power of the study will be set at 80% with a 95% confidence level.

The sample size was calculated based on a previous study by Inthihas et al in 2019, in which the success rate of proximal giomer restorations in primary molars was 94.1% after 12 months (17).

By implementing a two tailed Z test for the difference between two independent proportions with an alpha level of 5% and a power of 80%.

The minimum sample size needed was 28 per group in order to detect a difference of 30%.

Sample size was increased by 15% to compensate for possible dropouts to reach 32 teeth per group. Sample size was performed using G*Power version 3.1.9.2 for windows.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11553
        • Faculty of Dentistry,Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients:

    • Children aged 4-8 years.
    • Medically free.

Teeth:

  • Restorable Class II cavities.
  • Asymptomatic tooth.

Pre-operative radiographic examination:

  • Absence of periapical or inter-radicular radiolucency.
  • Absence of widening of periodontal ligaments space.
  • Absence of internal or external root resorption.

Exclusion Criteria:

  • Patients:

    • Uncooperative children.
    • Unable to attend follow-up visits.
    • Parents refuse to sign the informed consent.
    • Children participating in any other clinical trial involving fluoride therapy or other interventions that could directly influence caries development during the study period.

Teeth:

  • Teeth which were previously restored.
  • Mobility.

Pre-operative radiographic examination:

  • Caries extending deep sub-gingivally.
  • The tooth is about to exfoliate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: injectable composite
it is a type of zero flow injectable composite used to restore teeth and molars
Other: injectable composite
type of zero flow injectable composite
Other: Packable composite
composite used to restore molars
Other: packable composite
packable composite used to restore teeth and molars

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Assessment of Injectable Composite Versus Packable Composite in The Restoration of Cavitated Primary Molars
Time Frame: Time: T0 = baseline assessment and procedure will be done. T1 =3 months follow up. T2 = 6 months follow up. T3 = One-year follow-up.

Clinical evaluation will be done according to Fédération Dentaire Internationale FDI criteria

Scores:

Clinically excellent = 1 Clinically good = 2 Clinically sufficient = 3 Clinically unsatisfactory = 4 Clinically poor = 5
Time: T0 = baseline assessment and procedure will be done. T1 =3 months follow up. T2 = 6 months follow up. T3 = One-year follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiographic Assessment of Injectable Composite Versus Packable Composite in The Restoration of Cavitated Primary Molars.
Time Frame: t = 0 months t2 = 6 months t3 = 12 months
radiographic assessment will be done by using bitewing x-ray
t = 0 months t2 = 6 months t3 = 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eslam samy abdel monaem kalboush

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eslam Kalboush, Mcs, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 191131345021234567891911313450

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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