10 Years Evaluation of Composite Restoration

May 5, 2016 updated by: Nicola Barabanti, BNM Clinic and Research

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

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,

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Astralis 10 HPM
Polymerization High-power mode: 1300 mW/cm2 for 10 s
Device: Astralis 10 RM
The cavity to be filled is in quadrant II or IV
EXPERIMENTAL: Astralis 10 RM
Polymerisation regular mode: 650 mW/cm2 for 20
Device: Astralis 10 HPM
The cavity to be filled is in quadrant I or III

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BNM Clinic and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

April 8, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (ESTIMATE)

May 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TEX-10y-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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