NCT05952609

Brief Summary

The aim of this study is to evaluate and compare the clinical performance of 2 ion-releasing bulk-fill restorative materials in comparison with a bulk-fill resin composite restoration in posterior cavities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

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

February 10, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
Last Updated

July 19, 2023

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

July 11, 2023

Last Update Submit

July 11, 2023

Conditions

Secondary Caries

Outcome Measures

Primary Outcomes (3)

  • Evaluating surface and marginal staining

    FDI criteria will be used

    2 years

  • Evaluating fracture and retention of the materials

    FDI criteria will be used

    2-years

  • Evaluating marginal adaptation and discoloration of the materials

    FDI criteria will be used

    2-years

Study Arms (3)

Group 1

EXPERIMENTAL

Patients receiving Surefil One

Other: Surefil One

Group 2

EXPERIMENTAL

Patients receiving Cention N

Other: Cention N

Group 3

ACTIVE COMPARATOR

Patients receiving bulkfil resin composite

Other: Bulkfil resin composite

Interventions

Surefil OneOTHER

Ion-releasing restoration

Group 1
Cention NOTHER

Ion-releasing restoration

Group 2
Bulkfil resin compositeOTHER

resin composite (No ion-release)

Group 3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlyia, 35511, Egypt

Location

Study Design

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

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 19, 2023

Study Start

February 10, 2021

Primary Completion

April 15, 2023

Study Completion

May 15, 2023

Last Updated

July 19, 2023

Record last verified: 2021-04

Locations

EG(1)