CClinicalTrials.gg
Not yet recruitingNCT06790511Updated Jan 24, 2025

Clinical Performance of Bioactive Highly Filled Injectable Flowable Composite for Direct Posterior Occlusal Conservative Restorations Using FDI Criteria: Two Year Randomized Clinical Trial

An Early Phase 1 interventional study of bioactive highly filled injectable flowable composite and highly filled injectable flowable composite in Dental Caries, sponsored by Cairo University. Not yet recruiting. Open to participants aged 16 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-24.

Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
16 Years to 45 Years
Sex
All
01

Study 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

02

Conditions studied

  • Dental Caries

Browse trials for

03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:The inclusion criteria: patient age range from 16-45 years, with a premolar indicated for extraction, patients required at least a couple of Class I restorations. The patient should have good general health.

-

Exclusion Criteria:Where the exclusion criteria will be: poor oral hygiene, sever or chronic periodontal disease or bruxism, severe tooth sensitivity, non-vital or fracture or cracked teeth, defective restorations or bleaching procedures during the last 6 months, pregnancy, and/or lactation, and allergy to the main components of the products to be used in the study.

-

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Control Group

    Other: highly filled injectable flowable composite

  • Experimental
    Intervention

    Other: bioactive highly filled injectable flowable composite

Interventions

  • Otherbioactive highly filled injectable flowable composite

    bioactive highly filled injectable flowable composite

    Also known as: Shofou Flow Plus X

  • Otherhighly filled injectable flowable composite

    highly filled injectable flowable composite

    Also known as: GC G-ænial Universal Flo

06

What researchers measure

Primary outcomes

  1. Recurrence of caries

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

    Time frame: 24 Months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06790511
Lead sponsor
Cairo University
Responsible party
Mohamed Sherif (Ass. Lectuerer, Cairo University) — Principal investigator
First posted
Jan 24, 2025
Start date
Jan 20, 2025 (estimated)
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Jan 24, 2025

Study contacts

Mohamed Sherif ElAshmawy
Contact
mohamed.sherif@dentistry.cu.edu.eg
+201112759933

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion