NCT02764450

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,

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

10.9 years

First QC Date

April 8, 2016

Last Update Submit

May 5, 2016

Conditions

Dental Restoration, Permanent

Keywords

compositerestorationpolymerization

Outcome Measures

Primary Outcomes (1)

  • Number of cavity filled with problem in marginal adaptation and in marginal discoloration

    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

    5 years

Study Arms (2)

Astralis 10 HPM

EXPERIMENTAL

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

Device: Astralis 10 RM

Astralis 10 RM

EXPERIMENTAL

Polymerisation regular mode: 650 mW/cm2 for 20

Device: Astralis 10 HPM

Interventions

Astralis 10 HPMDEVICE

The cavity to be filled is in quadrant I or III

Astralis 10 RM
Astralis 10 RMDEVICE

The cavity to be filled is in quadrant II or IV

Astralis 10 HPM

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 23454329BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2016

First Posted

May 6, 2016

Study Start

April 1, 2004

Primary Completion

March 1, 2015

Last Updated

May 6, 2016

Record last verified: 2016-05