One-year Clinical Evaluation of Bulk-fill Versus Conventional Incremental Posterior Restoration by FDI Criteria

September 7, 2016 updated by: Mary Sabry Tawfik Tadros, Cairo University

One-year Clinical Evaluation of Bulk-fill Resin Composite Using FDI Criteria in Comparison to Conventional Incremental Posterior Restoration

restoring posterior teeth by bulk fll and nanofill composite and clinical evaluation of performance and durability of both restorations during one year follow up

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The treated cavities will be divided into 2 groups, cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (XL 3000; 3M/eSPe), with an energy higher than 450 mW/cm² (±50 mw/cm²) and other group of cavities will be restored by bulk fill composite (3M ESPE) as one increment then will be cured as directed by the manufacturer with the light curing unit.

Articulation will be checked carefully with an articulating paper and occlusal adjustments will be performed using flame shaped carbide and diamond finishing burs (DENTSPLY) using water spray, restorations will be finished occlusally with finishing burs and finally polished with aluminium oxide polishing paste and a rubber cup (DENTSPLY).

Study Type

Interventional

Enrollment (Anticipated)

69

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 38 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Good oral hygiene.Patients must show no signs of orofacial pain. The presence of molar teeth requiring composite restorations for the treatment of primary carious lesions

Exclusion Criteria:

  • Teeth with abnormal periapical anatomy or caries that will be likely to result in very deep restorations. Teeth with old restorations or severely destructed dental crowns.Tempro-mandibular joint problems involving symptomatic pain.Pregnancy or breast feeding, acute and chronic systemic diseases, immune-compromised patients

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Bulk full composite (3M)
bulk fill composite in posterior class one cavities
Other: bulk fill composite
cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (XL 3000; 3M/eSPe), with an energy higher than 450 mW/cm² (±50 mw/cm²)
Other: Nano resin composite (K Z350 xt)
cavities will be restored by bulk fill composite (3M ESPE) as one increment then will be cured as directed by the manufacturer with the light curing unit.
OTHER: Incremental packing composite resin
Nano resin composite (K Z350 xt) restoration in class one cavities
Other: bulk fill composite
cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (XL 3000; 3M/eSPe), with an energy higher than 450 mW/cm² (±50 mw/cm²)
Other: Nano resin composite (K Z350 xt)
cavities will be restored by bulk fill composite (3M ESPE) as one increment then will be cured as directed by the manufacturer with the light curing unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical performance and durability of restoration
Time Frame: one year
Outcome measure is Clinical performance and durability of composite resin restoration, Device for measurement is FDI criteria , Unit of measurement is Ranking system has 5 scores for each different criterion. Either restoration is clinically excellent, or good, or sufficient, or unsatisfactory, or clinically poor.
one year

Collaborators and Investigators

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

Sponsor

Cairo University

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

January 1, 2018

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (ESTIMATE)

September 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-08-184

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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