Clinical Performance of Injectable Universal Flowable Composite in Proximal Cavities of Posterior Teeth.

NCT05263089 | Completed

• 1 other identifier: Universal flowable composite
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the clinical performance of injectable universal flowable composite vs conventional resin composite restorations in proximal cavities of posterior teeth. The null hypothesis is proposed that there will be no difference in the clinical performance of injectable universal flowable composite versus conventional resin composite restorations in proximal cavities of posterior teeth. The design for this randomized controlled clinical trial is a superiority framework with parallel groups with equal allocation ratios. The patients are randomly divided into two groups where one group will receive conventional resin composite and the other group will receive injectable universal flowable resin composite. The restorations will be evaluated for any fracture or loss of retention by using prob following Modified USPHS criteria at baseline, 3, 6, 12 month.

Conditions

Proximal Cavities of Posterior Teeth

Keywords

Injectable universal flowable composite; Conventional resin composite; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Criteria of restoration evaluation indicating clinical performance.

  The restoration will be evaluated for any fracture or loss of retention by using prob following Modified USPHS criteria.

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Injectable Universal flowable resin composite

Other: PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability)

Control

ACTIVE COMPARATOR

Conventional resin composite

Other: ESTELITE® Alpha; Tokuyama, Tokyo, Japan

Interventions

PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability) OTHER

Supplied in L-syringe with nozzle and dispensing Tips. "Super Low" has low flowability, non-slumping, non-running, and precision stacking properties. The layer dispensed will be 2 mm. in thickness and cured for 40 s.

Also known as: Injectable Universal flowable resin composite

Intervention

ESTELITE® Alpha; Tokuyama, Tokyo, Japan OTHER

The composite was inserted using the incremental technique. Each increment of 2 mm was cured for 40 s.

Also known as: Conventional resin composite

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 18-55 years.
• Patients with good oral hygiene (mild to moderate plaque accumulation).
• patients with asymptomatic compound proximal cavities in permanent posterior teeth.
• ICDAS (3 \&4)
• Vital posterior teeth with compound proximal cavities.
• Teeth with no or minimum mobility
• No history of hypersensitivity in the teeth to be restored
• Free from signs and symptoms of pulpitis and pulpal necrosis.

You may not qualify if:

• Patients who are unable to return for recall appointments.
• Patients with poor oral hygiene.
• Presence of abnormal oral, medical, or mental condition
• Patients with untreated extra occlusal stresses
• Patients with TMJ problems.
• Root involvement.
• Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
• Fractured or visibly cracked teeth.
• Presence of any developmental or formative defects.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related Publications (21)

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• Ferracane JL, Lawson NC. Probing the hierarchy of evidence to identify the best strategy for placing class II dental composite restorations using current materials. J Esthet Restor Dent. 2021 Jan;33(1):39-50. doi: 10.1111/jerd.12686. Epub 2020 Nov 18.

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• Frascino S, Fagundes TC, Silva U, Rahal V, Barboza A, Santos PH, Briso A. Randomized Prospective Clinical Trial of Class II Restorations Using Low-shrinkage Flowable Resin Composite. Oper Dent. 2020 Jan/Feb;45(1):19-29. doi: 10.2341/18-230-C. Epub 2019 Apr 29.

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• Irmak O, Yaman BC, Orhan EO, Ozer F, Blatz MB. Effect of rubbing force magnitude on bond strength of universal adhesives applied in self-etch mode. Dent Mater J. 2018 Jan 30;37(1):139-145. doi: 10.4012/dmj.2017-018. Epub 2017 Oct 27.

  PMID: 29081447 BACKGROUND

• Imai A, Takamizawa T, Sugimura R, Tsujimoto A, Ishii R, Kawazu M, Saito T, Miyazaki M. Interrelation among the handling, mechanical, and wear properties of the newly developed flowable resin composites. J Mech Behav Biomed Mater. 2019 Jan;89:72-80. doi: 10.1016/j.jmbbm.2018.09.019. Epub 2018 Sep 17.

  PMID: 30265868 BACKGROUND

• Ikeda I, Otsuki M, Sadr A, Nomura T, Kishikawa R, Tagami J. Effect of filler content of flowable composites on resin-cavity interface. Dent Mater J. 2009 Nov;28(6):679-85. doi: 10.4012/dmj.28.679.

  PMID: 20019418 BACKGROUND

• Jang JH, Park SH, Hwang IN. Polymerization shrinkage and depth of cure of bulk-fill resin composites and highly filled flowable resin. Oper Dent. 2015 Mar-Apr;40(2):172-80. doi: 10.2341/13-307-L. Epub 2014 Aug 19.

  PMID: 25136904 BACKGROUND

• Kramer N, Reinelt C, Frankenberger R. Ten-year Clinical Performance of Posterior Resin Composite Restorations. J Adhes Dent. 2015 Aug;17(5):433-41. doi: 10.3290/j.jad.a35010.

  PMID: 26525008 BACKGROUND

• Kitasako Y, Sadr A, Burrow MF, Tagami J. Thirty-six month clinical evaluation of a highly filled flowable composite for direct posterior restorations. Aust Dent J. 2016 Sep;61(3):366-73. doi: 10.1111/adj.12387.

  PMID: 26573239 BACKGROUND

• Lai G, Zhao L, Wang J, Kunzelmann KH. Surface properties and color stability of dental flowable composites influenced by simulated toothbrushing. Dent Mater J. 2018 Sep 30;37(5):717-724. doi: 10.4012/dmj.2017-233. Epub 2018 Jul 12.

  PMID: 29998939 BACKGROUND

• Loguercio AD, Luque-Martinez I, Lisboa AH, Higashi C, Queiroz VA, Rego RO, Reis A. Influence of Isolation Method of the Operative Field on Gingival Damage, Patients' Preference, and Restoration Retention in Noncarious Cervical Lesions. Oper Dent. 2015 Nov-Dec;40(6):581-93. doi: 10.2341/14-089-C. Epub 2015 Jul 9.

  PMID: 26158415 BACKGROUND

• Stape THS, Wik P, Mutluay MM, Al-Ani AAS, Tezvergil-Mutluay A. Selective dentin etching: A potential method to improve bonding effectiveness of universal adhesives. J Mech Behav Biomed Mater. 2018 Oct;86:14-22. doi: 10.1016/j.jmbbm.2018.06.015. Epub 2018 Jun 8.

  PMID: 29913306 BACKGROUND

• Shaalan OO, Abou-Auf E, El Zoghby AF. Clinical evaluation of flowable resin composite versus conventional resin composite in carious and noncarious lesions: Systematic review and meta-analysis. J Conserv Dent. 2017 Nov-Dec;20(6):380-385. doi: 10.4103/JCD.JCD_226_17.

  PMID: 29430087 BACKGROUND

• Stefanski S, van Dijken JW. Clinical performance of a nanofilled resin composite with and without an intermediary layer of flowable composite: a 2-year evaluation. Clin Oral Investig. 2012 Feb;16(1):147-53. doi: 10.1007/s00784-010-0485-8. Epub 2010 Nov 23.

  PMID: 21104100 BACKGROUND

• Sumino N, Tsubota K, Takamizawa T, Shiratsuchi K, Miyazaki M, Latta MA. Comparison of the wear and flexural characteristics of flowable resin composites for posterior lesions. Acta Odontol Scand. 2013 May-Jul;71(3-4):820-7. doi: 10.3109/00016357.2012.734405.

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• Rocha Gomes Torres C, Rego HM, Perote LC, Santos LF, Kamozaki MB, Gutierrez NC, Di Nicolo R, Borges AB. A split-mouth randomized clinical trial of conventional and heavy flowable composites in class II restorations. J Dent. 2014 Jul;42(7):793-9. doi: 10.1016/j.jdent.2014.04.009. Epub 2014 Apr 25.

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• van Dijken JW, Pallesen U. A six-year prospective randomized study of a nano-hybrid and a conventional hybrid resin composite in Class II restorations. Dent Mater. 2013 Feb;29(2):191-8. doi: 10.1016/j.dental.2012.08.013. Epub 2012 Oct 9.

  PMID: 23063254 BACKGROUND

• Veloso SRM, Lemos CAA, de Moraes SLD, do Egito Vasconcelos BC, Pellizzer EP, de Melo Monteiro GQ. Clinical performance of bulk-fill and conventional resin composite restorations in posterior teeth: a systematic review and meta-analysis. Clin Oral Investig. 2019 Jan;23(1):221-233. doi: 10.1007/s00784-018-2429-7. Epub 2018 Mar 28.

  PMID: 29594349 BACKGROUND

• Wang Y, Li C, Yuan H, Wong MC, Zou J, Shi Z, Zhou X. Rubber dam isolation for restorative treatment in dental patients. Cochrane Database Syst Rev. 2016 Sep 20;9(9):CD009858. doi: 10.1002/14651858.CD009858.pub2.

  PMID: 27648846 BACKGROUND

• Yazici AR, Kutuk ZB, Ergin E, Karahan S, Antonson SA. Six-year clinical evaluation of bulk-fill and nanofill resin composite restorations. Clin Oral Investig. 2022 Jan;26(1):417-426. doi: 10.1007/s00784-021-04015-2. Epub 2021 Jun 10.

  PMID: 34110494 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant, conservative Dentistry Department, Faculty of Dentistry, MSA university

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 2, 2022
• Study Start: April 1, 2022
• Primary Completion: April 2, 2023
• Study Completion: April 2, 2023
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)