A 2-year Clinical Performance of Two Different Ion-releasing Bulk-fill Restorative Materials Posterior Cavities

A 2-year Clinical Performance of Two Different Ion-releasing Bulk-fill Restorative Materials Placed in Posterior Cavities

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.

Study Overview

• Status: Completed
• Conditions: Secondary Caries
• Intervention / Treatment: Other: Surefil One; Other: Cention N; Other: Bulkfil resin composite

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlyia
    • Mansoura, Dakahlyia, Egypt, 35511
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Criteria for patient's inclusion in the study will be the presence of at least 3 occlusal or proximal carious lesion in posterior teeth, favourable and stable occlusion between the remaining teeth, the patients must be older than 18 years old with permanent dentition, moderate oral hygiene, asymptomatic vital teeth with no sensitivity to percussion, and the presence of contact with adjacent teeth

Exclusion Criteria:

• Exclusion criteria will be, sever bruxism, patients with known unavailability to attend recall visits, patients with known allergy to any component of the study materials, pulp exposure during caries excavation, patients with unstable medical conditions and pregnant or lactating individuals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Patients receiving Surefil One	Other: Surefil One; Ion-releasing restoration
Experimental: Group 2; Patients receiving Cention N	Other: Cention N; Ion-releasing restoration
Active Comparator: Group 3; Patients receiving bulkfil resin composite	Other: Bulkfil resin composite; resin composite (No ion-release)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: M02060421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No