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

Secondary Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05952609
• Other study ID #: M02060421
• Status: Completed
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: April 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Secondary Caries

Intervention

Other:
• Surefil One
Ion-releasing restoration
• Cention N
Ion-releasing restoration
• Bulkfil resin composite
resin composite (No ion-release)

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakahlyia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating surface and marginal staining	FDI criteria will be used	2 years
Primary	Evaluating fracture and retention of the materials	FDI criteria will be used	2-years
Primary	Evaluating marginal adaptation and discoloration of the materials	FDI criteria will be used	2-years