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Completed

NCT Number: NCT02764450

10 Years Evaluation of Composite Restoration

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,

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Key information

Conditions

Dental Restoration, Permanent

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Astralis 10 HPM

Device

The cavity to be filled is in quadrant I or III

Astralis 10 RM

Device

The cavity to be filled is in quadrant II or IV

Primary outcomes

  1. Number of cavity filled with problem in marginal adaptation and in marginal discoloration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

BNM Clinic and Research

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2015
First posted
May 6, 2016
Registry last updated
May 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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