NCT04720638

Brief Summary

Clinical performance of short fiber reinforced flowable resin composite restorations versus conventional resin composite restorations will be tested in posterior teeth (2y randomized clinical trial).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

2.1 years

First QC Date

January 19, 2021

Last Update Submit

January 22, 2021

Conditions

Decay, DentalCaries Class II

Keywords

short fiber reinforced flowable resin compositeClinical performanceEver X flowRandomized clinical study

Outcome Measures

Primary Outcomes (1)

  • Clinical performance (Alpha is the best score, bravo, charlie the worst score)

    Modified USPHS criteria; . Post operative Hypersensitivity Secondary caries Gross fracture Color match Cavo-surface marginal discoloration Marginal integrity Proximal contact

    Change from baseline at 6, 12 ,18, 24 months

Study Arms (2)

Short fiber reinforced flowable resin composite restorations

EXPERIMENTAL

(everX Flow, GC Europe) + (Gaenial posterior, GC Europe

Other: Short fiber reinforced flowable resin composite restorations

Conventional resin composite restoration.

ACTIVE COMPARATOR

(Gaenial posterior, GC Europe)

Other: Conventional resin composite restoration

Interventions

Short fiber reinforced flowable resin composite restorationsOTHER

reinforced flowable resin composite

Also known as: Ever X Flow
Short fiber reinforced flowable resin composite restorations
Conventional resin composite restorationOTHER

Microhybrid resin composite

Also known as: Gaenial posterior, GC Europe
Conventional resin composite restoration.

Eligibility Criteria

Age17 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with large proximal carious cavities in molars.
  • Pulp asymptomatic vital carious upper or lower molars.
  • Good oral hygiene.

You may not qualify if:

  • Presence of signs and symptoms of irreversible pulpitis or pulp necrosis
  • Severe medical complications.
  • Allergic history concerning methacrylates
  • Evidence of parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 11331, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Rawda Hesham

    Lecturer at faculty of Dentistry- Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rawda Hesham A ElAziz

CONTACT

01001097200rawda.hesham@dentistry.cu.edu.eg

Sherifa Ahmed

CONTACT

Sherifa.Ahmed@dentistry.cu.edu.eg

Study Design

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

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 22, 2021

Study Start

March 1, 2021

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)