Back to results

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

Primary Purpose

Caries,Dental

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

thermoviscous bulkfill composite (Viscalor)

About this trial

This is an interventional treatment trial for Caries,Dental

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

thermoviscous bulk fill resin composite

conventional bulk fill resin composite

Arm Description

Outcomes

Primary Outcome Measures

modified United States Public Health Service criteria (USPHS)

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

post operative senstivity

Full Information

NCT ID

NCT05276154

First Posted

March 2, 2022

Last Updated

March 10, 2022

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05276154

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 15, 2022 (Anticipated)

Primary Completion Date

May 15, 2023 (Anticipated)

Study Completion Date

October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Caries,Dental

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

thermoviscous bulk fill resin composite

Arm Type

Active Comparator

Arm Title

conventional bulk fill resin composite

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

thermoviscous bulkfill composite (Viscalor)

Intervention Description

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.

Primary Outcome Measure Information:

Title

modified United States Public Health Service criteria (USPHS)

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

post operative senstivity

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed Amr, MDS

Phone

01224406444

drahmedamr999@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mona Riyad, Professor

Phone

01006608683

monariad50@hotmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

31596369

Citation

Balkaya H, Arslan S, Pala K. A randomized, prospective clinical study evaluating effectiveness of a bulk-fill composite resin, a conventional composite resin and a reinforced glass ionomer in Class II cavities: one-year results. J Appl Oral Sci. 2019 Oct 7;27:e20180678. doi: 10.1590/1678-7757-2018-0678. eCollection 2019.

Results Reference

background

PubMed Identifier

21779058

Citation

Rickman LJ, Padipatvuthikul P, Chee B. Clinical applications of preheated hybrid resin composite. Br Dent J. 2011 Jul 22;211(2):63-7. doi: 10.1038/sj.bdj.2011.571.

Results Reference

background

PubMed Identifier

18335736

Citation

Wagner WC, Aksu MN, Neme AM, Linger JB, Pink FE, Walker S. Effect of pre-heating resin composite on restoration microleakage. Oper Dent. 2008 Jan-Feb;33(1):72-8. doi: 10.2341/07-41. Erratum In: Oper Dent. 2009 Mar-Apr;34(2):246. Asku, Mert N [corrected to Aksu, Mert N].

Results Reference

background

PubMed Identifier

21029335

Citation

Rueggeberg FA, Daronch M, Browning WD, DE Goes MF. In vivo temperature measurement: tooth preparation and restoration with preheated resin composite. J Esthet Restor Dent. 2010 Oct;22(5):314-22. doi: 10.1111/j.1708-8240.2010.00358.x.

Results Reference

background

PubMed Identifier

27892839

Citation

Costa T, Rezende M, Sakamoto A, Bittencourt B, Dalzochio P, Loguercio AD, Reis A. Influence of Adhesive Type and Placement Technique on Postoperative Sensitivity in Posterior Composite Restorations. Oper Dent. 2017 Mar/Apr;42(2):143-154. doi: 10.2341/16-010-C. Epub 2016 Nov 28.

Results Reference

background

PubMed Identifier

30938633

Citation

Campbell I, Kang J, Hyde TP. Randomized Controlled Trial of Postoperative Sensitivity with Warm and Room Temperature Composite. JDR Clin Trans Res. 2017 Jul;2(3):295-303. doi: 10.1177/2380084416682934. Epub 2016 Dec 20.

Results Reference

background

PubMed Identifier

30503020

Citation

Lempel E, Ori Z, Szalma J, Lovasz BV, Kiss A, Toth A, Kunsagi-Mate S. Effect of exposure time and pre-heating on the conversion degree of conventional, bulk-fill, fiber reinforced and polyacid-modified resin composites. Dent Mater. 2019 Feb;35(2):217-228. doi: 10.1016/j.dental.2018.11.017. Epub 2018 Nov 28.

Results Reference

background

PubMed Identifier

33268693

Citation

Demirel G, Orhan AI, Irmak O, Aydin F, Buyuksungur A, Bilecenoglu B, Orhan K. Micro-computed tomographic evaluation of the effects of pre-heating and sonic delivery on the internal void formation of bulk-fill composites. Dent Mater J. 2021 Mar 31;40(2):525-531. doi: 10.4012/dmj.2020-071. Epub 2020 Dec 2.

Results Reference

background

PubMed Identifier

33353736

Citation

Loumprinis N, Maier E, Belli R, Petschelt A, Eliades G, Lohbauer U. Viscosity and stickiness of dental resin composites at elevated temperatures. Dent Mater. 2021 Mar;37(3):413-422. doi: 10.1016/j.dental.2020.11.024. Epub 2021 Jan 19.

Results Reference

background

PubMed Identifier

32386715

Citation

Yang J, Silikas N, Watts DC. Pre-heating time and exposure duration: Effects on post-irradiation properties of a thermo-viscous resin-composite. Dent Mater. 2020 Jun;36(6):787-793. doi: 10.1016/j.dental.2020.03.025. Epub 2020 May 5.

Results Reference

background

PubMed Identifier

32888725

Citation

Marcondes RL, Lima VP, Barbon FJ, Isolan CP, Carvalho MA, Salvador MV, Lima AF, Moraes RR. Viscosity and thermal kinetics of 10 preheated restorative resin composites and effect of ultrasound energy on film thickness. Dent Mater. 2020 Oct;36(10):1356-1364. doi: 10.1016/j.dental.2020.08.004. Epub 2020 Sep 1.

Results Reference

background

PubMed Identifier

32994869

Citation

Ebrahimi-Chaharom ME, Safyari L, Safarvand H, Jafari-Navimipour E, Alizadeh-Oskoee P, Ajami AA, Abed-Kahnamouei M, Bahari M. The effect of pre-heating on monomer elution from bulk-fill resin composites. J Clin Exp Dent. 2020 Sep 1;12(9):e813-e820. doi: 10.4317/jced.56989. eCollection 2020 Sep.

Results Reference

background

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/32446504/

Description

Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs