10 Years Evaluation of Composite Restoration

Marginal Quality of Posterior Microhybrid Resin Composite Restorations Applied Using Two Polymerisation Protocols

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02764450

Enrollment

Registered

2016-05-06

Start date

2004-04-30

Completion date

Unknown

Last updated

2016-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Restoration, Permanent

Keywords

composite, restoration, polymerization

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,

Interventions

DEVICEAstralis 10 HPM

The cavity to be filled is in quadrant I or III

DEVICEAstralis 10 RM

The cavity to be filled is in quadrant II or IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026