NCT06226389

Brief Summary

Different bulk-fill composites will be applied in different posterior cavities then compared

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration 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

December 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 17, 2024

Last Update Submit

April 27, 2026

Conditions

Carious Teeth

Keywords

Bulk-fill composite, posterior cavities

Outcome Measures

Primary Outcomes (1)

  • Difference between baseline and after 2 years of evaluation of resin based composite

    Change in FDI criteria

    Baseline to 2 years

Study Arms (4)

Arm 1:flowable Bulk-fill composite

EXPERIMENTAL

Posterior cavities restored using a flowable bulk-fill resin composite placed in a single increment according to the manufacturer's instruction

Procedure: Flowable bulk-fill resin composite

Preheated bulk-fill composite

EXPERIMENTAL

Posterior cavities restored using a preheated bulk-fill resin composite placed in a single increment according to the manufacturer's instruction

Procedure: preheated bulk-fill resin composite

sonic activated bulk-fill composite

EXPERIMENTAL

Posterior cavities restored using a sonic bulk-fill resin composite placed in a single increment according to the manufacturer's instruction

Procedure: sonic bulk-fill resin composite

conventional bulk-fill composite

EXPERIMENTAL

Posterior cavities restored using a conventional bulk-fill resin composite placed in a single increment according to the manufacturer's instruction

Procedure: conventional bulk-fill resin composite

Interventions

Flowable bulk-fill resin compositePROCEDURE

Flowable bulk-fill resin composite material used for posterior restorations

Arm 1:flowable Bulk-fill composite
preheated bulk-fill resin compositePROCEDURE

preheated bulk-fill resin composite material used for posterior restorations

Preheated bulk-fill composite
sonic bulk-fill resin compositePROCEDURE

sonic bulk-fill resin composite material used for posterior restorations

sonic activated bulk-fill composite
conventional bulk-fill resin compositePROCEDURE

conventional bulk-fill resin composite material used for posterior restorations

conventional bulk-fill composite

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • at least 4 carious molars

You may not qualify if:

  • pregnancy patient
  • Not able to regularly follow up
  • bad oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura,Faculty of Dentistry

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Asmaa S Elsaeed, Assistant lecturer

    Assistant lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 26, 2024

Study Start

December 1, 2023

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Yes Study Protocol, Statistical Analysis Plan can be shared to other researchers

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available after 2 years
Access Criteria
For anyone

Locations

EG(1)