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

Not Applicable

Completed

• Conditions: Secondary Caries
• Interventions: Other: Bulkfil resin composite; Other: Surefil One; Other: Cention N

• Registration Number: NCT05952609
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-10
• Status Verified: 2021-04
• Primary Completion: 2023-04-15
• Study Completion: 2023-05-15
• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-11
• Study First Posted: 2023-07-19
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 3	Bulkfil resin composite	Patients receiving bulkfil resin composite
Group 1	Surefil One	Patients receiving Surefil One
Group 2	Cention N	Patients receiving Cention N

Primary Outcome Measures

Name	Time	Method
Evaluating surface and marginal staining	2 years	FDI criteria will be used
Evaluating marginal adaptation and discoloration of the materials	2-years	FDI criteria will be used
Evaluating fracture and retention of the materials	2-years	FDI criteria will be used

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Dakahlyia, Egypt