NCT06790511

Brief Summary

The aim of this study is to evaluate Clinical Performance of bioactive highly filled injectable flowable composite for direct posterior occlusal conservative restorations using FDI Criteria

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
8mo left

Started Jan 2025

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 Progress66%
Jan 2025Jan 2027

First Submitted

Initial submission to the registry

January 18, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

January 18, 2025

Last Update Submit

January 18, 2025

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Recurrence of caries

    Restorations will be assessed for recurrence of caries by visual examination, short air drying

    24 Months

Study Arms (2)

Control Group

ACTIVE COMPARATOR
Other: highly filled injectable flowable composite

Intervention

EXPERIMENTAL
Other: bioactive highly filled injectable flowable composite

Interventions

bioactive highly filled injectable flowable compositeOTHER

bioactive highly filled injectable flowable composite

Also known as: Shofou Flow Plus X
Intervention
highly filled injectable flowable compositeOTHER

highly filled injectable flowable composite

Also known as: GC G-ænial Universal Flo
Control Group

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Mohamed Sherif ElAshmawy

CONTACT

+201112759933mohamed.sherif@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Lectuerer

Study Record Dates

First Submitted

January 18, 2025

First Posted

January 24, 2025

Study Start

January 20, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL