Clinical Performance of Thermoviscous Bulk Fill Resin Composites in Comparison to Conventional Packable Bulk Fills

March 10, 2022 updated by: Ahmed Amr Kamal, Minia University

Clinical Performance of Thermo-Viscous Bulk-Fill Resin Composite Restorations in Comparison to Conventional Bulk-Fill Resin Composite Restorations in Posterior Teeth A Randomized Control Clinical Trial

This clinical trial will be conducted to compare the clinical performance of the thermo-viscous preheated bulk fill composite in the management of carious lesions in posterior teeth in adult patients over 12 months.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have at least two molars supported permanent dentition free of any clinically significant occlusal interference and require posterior restoration and fulfilled the inclusion criteria, patients will be informed about the study and will be given an informed consent.

    • The two studied materials restorations should be used in approximately the same sized lesions or within the same extensions.
    • The patient will be reimbursed for attending for the clinical evaluation(s) of their restorations.
    • Be a regular dental attender who agree to return for assessments.

Exclusion Criteria:

  • There is history of any adverse reaction to clinical materials of the type to be used in the study.
  • There was evidence of occlusal parafunction and/or pathological tooth wear.
  • Patients whose history revealed parafunctional habits or use of medications that potentially could cause hyposalivation.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: thermoviscous bulk fill resin composite
Other: thermoviscous bulkfill composite (Viscalor)
a relatively new product of composite resin which is transformed from high viscosity to low viscosity by the action of head produced by a heating device.
Active Comparator: conventional bulk fill resin composite
Other: thermoviscous bulkfill composite (Viscalor)
a relatively new product of composite resin which is transformed from high viscosity to low viscosity by the action of head produced by a heating device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified United States Public Health Service criteria (USPHS)
Time Frame: 1 year
scores A,B,C ( A highest score) (C the lowest score) and overall evaluation for the restorations ( Alpha , bravo, charlie, delta) Alpha for the highest score and delta for the lowest scores
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
post operative senstivity
Time Frame: 1 week
1 week

Collaborators and Investigators

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

Sponsor

Minia University

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

Helpful Links

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 (Anticipated)

April 15, 2022

Primary Completion (Anticipated)

May 15, 2023

Study Completion (Anticipated)

October 15, 2023

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USPHS for TV bulkfill RC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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