NCT07239154

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026May 2027

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

November 16, 2025

Last Update Submit

April 11, 2026

Conditions

Dental Caries in Children

Keywords

Decayed

Outcome Measures

Primary Outcomes (1)

  • Clinical Assessment of Injectable Composite Versus Packable Composite in The Restoration of Cavitated Primary Molars

    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 Outcomes (1)

  • Radiographic Assessment of Injectable Composite Versus Packable Composite in The Restoration of Cavitated Primary Molars.

    t = 0 months t2 = 6 months t3 = 12 months

Study Arms (2)

injectable composite

EXPERIMENTAL

it is a type of zero flow injectable composite used to restore teeth and molars

Other: injectable composite

Packable composite

OTHER

composite used to restore molars

Other: packable composite

Interventions

packable compositeOTHER

packable composite used to restore teeth and molars

Packable composite
injectable compositeOTHER

type of zero flow injectable composite

injectable composite

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry,Cairo university

Cairo, Cairo Governorate, 11553, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Eslam Kalboush, Mcs

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eslam Kalboush, Mcs

CONTACT

01028992916eslam.samy@dentistry.cu.edu.eg

Eslam Kalboush, Mcs

CONTACT

01141494591essamy22@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
outcome assessors
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer in pediatric dentistry department delta university

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

EG(1)