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

Sponsor
Minia University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05276154
Collaborator
(none)
32
Enrollment
2
Arms
18
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: thermoviscous bulkfill composite (Viscalor)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Apr 15, 2022
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
Oct 15, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. modified United States Public Health Service criteria (USPHS) [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

Secondary Outcome Measures

  1. post operative senstivity [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Ahmed Amr Kamal, Assistant lecturer (misr university for sciences and technology), Minia University
ClinicalTrials.gov Identifier:
NCT05276154
Other Study ID Numbers:
  • USPHS for TV bulkfill RC
First Posted:
Mar 11, 2022
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dental Caries

Study Results

No Results Posted as of Mar 25, 2022