10 Years Evaluation of Composite Restoration

NCT ID: NCT02764450

Last Updated: 2016-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Brief Summary

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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

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Conditions

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Dental Restoration, Permanent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Astralis 10 HPM

Polymerization High-power mode: 1300 mW/cm2 for 10 s

Group Type EXPERIMENTAL

Astralis 10 RM

Intervention Type DEVICE

The cavity to be filled is in quadrant II or IV

Astralis 10 RM

Polymerisation regular mode: 650 mW/cm2 for 20

Group Type EXPERIMENTAL

Astralis 10 HPM

Intervention Type DEVICE

The cavity to be filled is in quadrant I or III

Interventions

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Astralis 10 HPM

The cavity to be filled is in quadrant I or III

Intervention Type DEVICE

Astralis 10 RM

The cavity to be filled is in quadrant II or IV

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BNM Clinic and Research

OTHER

Sponsor Role lead

Responsible Party

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Nicola Barabanti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Barabanti N, Gagliani M, Roulet JF, Testori T, Ozcan M, Cerutti A. Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial. J Dent. 2013 May;41(5):436-42. doi: 10.1016/j.jdent.2013.02.009. Epub 2013 Feb 27.

Reference Type BACKGROUND
PMID: 23454329 (View on PubMed)

Other Identifiers

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TEX-10y-2016

Identifier Type: -

Identifier Source: org_study_id

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