Clinical Performance of Flowable Giomer Versus Nanofilled Composite in Conservative Occlusal Cavities
NCT ID: NCT06097143
Last Updated: 2025-09-29
Study Results
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Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2023-12-15
2025-06-21
Brief Summary
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Detailed Description
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Teeth that meet the inclusion criteria will be selected. The occlusal surfaces will be cleaned by pumice and a low speed polishing brush. Baseline recording of carious lesions will be carried out using DIAGNOdent pen. Cavity preparation will be carried out using number 330 (Mani, Inc., Japan) bur.
All the tested materials Shofu™ Beautifil Injectable X, (Shofu Dental Corp., Japan flowable composite) and Filtek™ Z350 XT (3M ESPE, USA) Flowable composite: Conventional resin-based nano-filled flowable composite which will then be coated with Shofu™ PRG Barrier Coat, (Shofu Dental Corp., Japan) will be used according to manufacturer instructions and comparator restorative material Filtek™ Z350 XT (3M ESPE, USA) Flowable composite.
All restorations will be finished using flame-shaped finishing stone (Mani, Inc., Japan) and polished using rubber cups (Kerr Corporation, Orange, CA, USA).
The primary and secondary outcomes will be measured at four intervals 1 week after placement, 6 months follow up, 12 months follow up and 18 months follow up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Flowable Giomer
Patients with conservative carious class I occlusal cavities will be treated with Shofu™ Beautifil Injectable X, Shofu Dental Corp., Japan flowable composite Novel bio-active flowable resin containing nano S-PRG (Surface Pre-Reacted Glass ionomer).
Flowable Giomer
Pre-reacted Glass Ionomer (PRG) filler is added to resin to create giomer, a dental adhesive material. Fluoride release and recharge, acid resistance, an anti-plaque effect, dentin remineralization, and acid buffering capacity are some of the benefits of giomer.
Nano-filled Flowable Composite with S-PRG barrier coat
Patients with conservative carious class I occlusal cavities will be treated with Filtek™ Z350 XT 3M ESPE, USA Flowable composite: Conventional resin-based nano-filled flowable composite which will then be coated with Shofu™ PRG Barrier Coat, Shofu Dental Corp., Japan.
Flowable Nano-filled composite with S-PRG barrier coat
Flowable composites are claimed to have a higher wetting ability of the tooth surface and thus ensure penetration into all surface irregularities in layers of minimal thickness. As a result of the higher amount of filler particles, it is noted that flowable composites have less porosity than conventional resin-based sealants. Moreover, flowable composite materials have better mechanical properties which lead to increased durability and longevity of the restoration.
The PRG Barrier Coat is a resinous coating substance that shields the enamel surface from demineralization brought on by acidic attack. Near the coated surface, S PRG filler ions in PRG Barrier Coat have been found to have an acid-neutralizing effect. F and Sr released by PRG Barrier Coat can be effectively absorbed by the tooth substrate to prevent demineralization thus hindering the progression of caries.
Nano-Filled Flowable Composite
Patients with conservative carious class I occlusal cavities will be treated with Filtek™ Z350 XT 3M ESPE, USA Flowable composite: Conventional resin-based nano-filled flowable composite.
Flowable Nano-filled composite
Flowable composites are claimed to have a higher wetting ability of the tooth surface and thus ensure penetration into all surface irregularities in layers of minimal thickness. As a result of the higher amount of filler particles, it is noted that flowable composites have less porosity than conventional resin-based sealants. Moreover, flowable composite materials have better mechanical properties which lead to increased durability and longevity of the restoration.
Interventions
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Flowable Giomer
Pre-reacted Glass Ionomer (PRG) filler is added to resin to create giomer, a dental adhesive material. Fluoride release and recharge, acid resistance, an anti-plaque effect, dentin remineralization, and acid buffering capacity are some of the benefits of giomer.
Flowable Nano-filled composite with S-PRG barrier coat
Flowable composites are claimed to have a higher wetting ability of the tooth surface and thus ensure penetration into all surface irregularities in layers of minimal thickness. As a result of the higher amount of filler particles, it is noted that flowable composites have less porosity than conventional resin-based sealants. Moreover, flowable composite materials have better mechanical properties which lead to increased durability and longevity of the restoration.
The PRG Barrier Coat is a resinous coating substance that shields the enamel surface from demineralization brought on by acidic attack. Near the coated surface, S PRG filler ions in PRG Barrier Coat have been found to have an acid-neutralizing effect. F and Sr released by PRG Barrier Coat can be effectively absorbed by the tooth substrate to prevent demineralization thus hindering the progression of caries.
Flowable Nano-filled composite
Flowable composites are claimed to have a higher wetting ability of the tooth surface and thus ensure penetration into all surface irregularities in layers of minimal thickness. As a result of the higher amount of filler particles, it is noted that flowable composites have less porosity than conventional resin-based sealants. Moreover, flowable composite materials have better mechanical properties which lead to increased durability and longevity of the restoration.
Eligibility Criteria
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Inclusion Criteria
* Patients with good oral health
* Small Class I carious lesion in occlusal pits and fissures
Exclusion Criteria
* Severe medical complications
* Allergy history concerning methacrylates
* Pregnancy
* Heavy smoking
* Evidence of severe bruxism, clenching or temporomandibular joint disorders
* Presence of existing occlusal restoration
* Periapical or pulpal pathology
* Tooth hypersensitivity
* Possible prosthodontic restoration of teeth
* Endodontically treated teeth
* Severe periodontal affection
19 Years
40 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Amina Ahmed Abdellatif Hassan Gaafar
Principle Investigator
Locations
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Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, Egypt
Countries
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References
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Ogawa Y, Sayed M, Hiraishi N, Al-Haj Husain N, Tagami J, Ozcan M, Shimada Y. Effect of Surface Pre-Reacted Glass Ionomer Containing Dental Sealant on the Inhibition of Enamel Demineralization. J Funct Biomater. 2022 Oct 14;13(4):189. doi: 10.3390/jfb13040189.
Baroudi K, Rodrigues JC. Flowable Resin Composites: A Systematic Review and Clinical Considerations. J Clin Diagn Res. 2015 Jun;9(6):ZE18-24. doi: 10.7860/JCDR/2015/12294.6129. Epub 2015 Jun 1.
Jafarzadeh M, Malekafzali B, Tadayon N, Fallahi S. Retention of a Flowable Composite Resin in Comparison to a Conventional Resin-Based Sealant: One-year Follow-up. J Dent (Tehran). 2010 Winter;7(1):1-5. Epub 2010 Mar 31.
Asefi S, Eskandarion S, Hamidiaval S. Fissure sealant materials: Wear resistance of flowable composite resins. J Dent Res Dent Clin Dent Prospects. 2016;10(3):194-9. doi: 10.15171/joddd.2016.031. Epub 2016 Aug 17.
Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
Jaafar N, Ragab H, Abedrahman A, Osman E. An In Vivo Investigation of Diagnostic Performance of DIAGNOdent Pen and the Canary System for Assessment and Monitoring Enamel Caries under Fissure Sealants. J Int Soc Prev Community Dent. 2020 Jun 15;10(3):246-254. doi: 10.4103/jispcd.JISPCD_480_19. eCollection 2020 May-Jun.
Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.
Kawasaki K, Kambara M. Effects of ion-releasing tooth-coating material on demineralization of bovine tooth enamel. Int J Dent. 2014;2014:463149. doi: 10.1155/2014/463149. Epub 2014 Jan 21.
Funato Y, Matsuda Y, Okuyama K, Yamamoto H, Komatsu H, Sano H. A new technique for analyzing trace element uptake by human enamel. Dent Mater J. 2015;34(2):240-5. doi: 10.4012/dmj.2014-127. Epub 2015 Feb 25.
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.
Other Identifiers
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Giomer Based Class I Cavities
Identifier Type: -
Identifier Source: org_study_id
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