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

NCT ID: NCT05276154

Last Updated: 2022-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2023-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Caries,Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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thermoviscous bulk fill resin composite

Group Type ACTIVE_COMPARATOR

thermoviscous bulkfill composite (Viscalor)

Intervention Type OTHER

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.

conventional bulk fill resin composite

Group Type ACTIVE_COMPARATOR

thermoviscous bulkfill composite (Viscalor)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Amr Kamal

Assistant lecturer (misr university for sciences and technology)

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ahmed Amr, MDS

Role: CONTACT

01224406444

Mona Riyad, Professor

Role: CONTACT

01006608683

References

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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.

Reference Type BACKGROUND
PMID: 31596369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21779058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18335736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21029335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27892839 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30938633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30503020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33268693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33353736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32386715 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32888725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32994869 (View on PubMed)

Related Links

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Other Identifiers

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USPHS for TV bulkfill RC

Identifier Type: -

Identifier Source: org_study_id

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