10 Years Evaluation of Composite Restoration

Not Applicable

Completed

• Conditions: Dental Restoration, Permanent
• Interventions: Device: Astralis 10 HPM; Device: Astralis 10 RM

• Registration Number: NCT02764450
• Lead Sponsor: BNM Clinic and Research

Brief Summary

This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I and Class II restorations made of microhybrid composite and applied using two polymerisation protocols,

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2015-03
• Study First Submitted: 2016-04-08
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-05
• Last Update Submitted: 2016-05-05
• Study First Posted: 2016-05-06
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• subjects at least 18 years old,
• require restorations due to primary caries in contralateral quadrants with opposing and adjacent tooth contact,
• having no restoration in the antagonist,

Exclusion Criteria

• allergic to resin-based materials,
• pregnant or nursing,
• periodontal disease

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Astralis 10 RM	Astralis 10 HPM	Polymerisation regular mode: 650 mW/cm2 for 20
Astralis 10 HPM	Astralis 10 RM	Polymerization High-power mode: 1300 mW/cm2 for 10 s

Primary Outcome Measures

Name	Time	Method
Number of cavity filled with problem in marginal adaptation and in marginal discoloration	5 years	Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial.; The evaluation was done using both SQUACE and USPHS criteria