NCT05276154

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

March 2, 2022

Last Update Submit

March 10, 2022

Conditions

Caries,Dental

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • post operative senstivity

    1 week

Study Arms (2)

thermoviscous bulk fill resin composite

ACTIVE COMPARATOR
Other: thermoviscous bulkfill composite (Viscalor)

conventional bulk fill resin composite

ACTIVE COMPARATOR
Other: thermoviscous bulkfill composite (Viscalor)

Interventions

thermoviscous bulkfill composite (Viscalor)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 compositethermoviscous bulk fill resin composite

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 31596369BACKGROUND

  • 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.

    PMID: 21779058BACKGROUND

  • 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.

    PMID: 18335736BACKGROUND

  • 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.

    PMID: 21029335BACKGROUND

  • 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.

    PMID: 27892839BACKGROUND

  • 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.

    PMID: 30938633BACKGROUND

  • 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.

    PMID: 30503020BACKGROUND

  • 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.

    PMID: 33268693BACKGROUND

  • 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.

    PMID: 33353736BACKGROUND

  • 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.

    PMID: 32386715BACKGROUND

  • 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.

    PMID: 32888725BACKGROUND

  • 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.

    PMID: 32994869BACKGROUND

Related Links

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Ahmed Amr, MDS

CONTACT

01224406444drahmedamr999@gmail.com

Mona Riyad, Professor

CONTACT

01006608683monariad50@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer (misr university for sciences and technology)

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 11, 2022

Study Start

April 15, 2022

Primary Completion

May 15, 2023

Study Completion

October 15, 2023

Last Updated

March 25, 2022

Record last verified: 2022-03