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

Caries,Dental Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05276154
• Other study ID #: USPHS for TV bulkfill RC
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: March 2022
• Source: Minia University
• Contact: Ahmed Amr, MDS
• Phone: 01224406444
• Email: drahmedamr999[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: October 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

References & Publications (12)

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. — View 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. — View 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. — View Citation

Demirel G, Orhan AI, Irmak Ö, 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. — View 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. — View Citation

Lempel E, Ori Z, Szalma J, Lovász BV, Kiss A, Tóth Á, Kunsági-Máté 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. — View 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. — View 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. — View 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. — View 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. — View 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]. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	post operative senstivity		1 week

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