NCT07320885

Brief Summary

the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

November 20, 2025

Last Update Submit

December 27, 2025

Conditions

Caries; DentinCaries Class II

Keywords

Fiber-reinforced resin compositeFlowable bulk-fill resin composite

Outcome Measures

Primary Outcomes (1)

  • Fracture of restorative material and restoration retention

    Clinical evaluation was performed one week after finishing and polishing (baseline), after 6 months, 1, 2, 3, 4 years using the World Dental Federation (FDI) criteria

    four years

Study Arms (3)

Ever x flow short-fiber reinforced composite

EXPERIMENTAL

Ever x flow was used as dentin replacement material in class II cavities

Other: Ever x flow

SDR flowable bulk-fill resin composite

EXPERIMENTAL

SDR was used as dentin replacement material

Other: SDR

Tetric N-Flow Bulk fill resin composite

EXPERIMENTAL

Tetric N-Flow Bulk fill was used as dentin replacement material

Other: Tetric N-Flow Bulk fill

Interventions

Tetric N-Flow Bulk fillOTHER

Tetric N-Flow Bulk fill was used as dentin replacement material in class II cavities

Tetric N-Flow Bulk fill resin composite
Ever x flowOTHER

Ever x flow was used as dentin replacement material

Also known as: flowable FRC
Ever x flow short-fiber reinforced composite
SDROTHER

SDR was used as dentin replacement material in class II cavities

SDR flowable bulk-fill resin composite

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • having good oral hygiene.
  • having at least 3 posterior teeth with moderate to large primary proximal carious lesions (score 4 or 5 ICDAS).
  • ranging in age from 20 to 40 years.
  • with normal occlusion.
  • accepting to participate in the study by signing an Arabic-written consent according to the regulations of the Mansoura University Ethical Committee.

You may not qualify if:

  • bad oral hygiene.
  • severe chronic periodontitis.
  • having installed orthodontic appliances.
  • abnormal occlusion.
  • parafunctional habits or allergic reaction to any of the materials used in the study.
  • teeth with irreversible pulpitis or non-vital teeth.
  • fractured or cracked teeth. previously restored teeth.
  • teeth with deep sub-gingival cavity margins.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

November 20, 2025

First Posted

January 6, 2026

Study Start

July 1, 2020

Primary Completion

August 15, 2024

Study Completion

August 15, 2024

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

no specific reason

Locations

EG(1)