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With limited evidence-based information in literature the goal of this clinical trial is to learn about Flowable Giomer and compare it to Nanofilled Flowable Composite in Conservative Occlusal Cavities. It is beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that this new flowable giomer (Shofu™ Beautifil Injectable X, Shofu Dental Corp., Japan) and conventional resin-based nano-filled composite (Filtek™ Z350 XT 3M ESPE, USA) which will then be coated with (Shofu™ PRG Barrier Coat, Shofu Dental Corp., Japan) will have the same clinical performance as flowable resin composite as a preventative restorative restoration in permanent molars.
This study will be conducted to clinically evaluate caries prevention and marginal integrity of flowable giomer and flowable resin composite coated with S-PRG in comparison to flowable resin composite as a preventative resin restoration in patients requiring minimally invasive simple class I cavities in permanent molars over 18 months test period.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flowable Giomer | Experimental | 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). |
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| Nano-filled Flowable Composite with S-PRG barrier coat | Experimental | 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. |
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| Nano-Filled Flowable Composite | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flowable Giomer | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fracture and Retention of Material | World Dental Federation (FDI) criteria (Hickel et al.,2010) Scores:
| T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion and wear | World Dental Federation (FDI) criteria | T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up |
| Marginal Adaptation | World Dental Federation (FDI) criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Cairo | Cairo Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36278658 | Background | 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. | |
| 26266238 | Background | 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. |
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|
| Flowable Nano-filled composite with S-PRG barrier coat | Other | 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 | Other | 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. |
|
| T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up |
| Form and contour | World Dental Federation (FDI) criteria | T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up |
| Dental hard tissue defects at restoration margins | World Dental Federation (FDI) criteria | T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up |
| Postoperative hypersensitivity/pulp status | World Dental Federation (FDI) criteria | T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up |
| Incidence of new carious lesions | Intra-oral quantitative light-induced fluorescence applied on the occlusal surface of permanent molars with initial Class I caries using DIAGNOdent pen Scores: 0 - 14 indicate a healthy occlusal surface 15 - 20 indicate the presence of enamel caries, 21 or more indicate the presence of dentinal caries | T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up |
| 21998768 | Background | 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. |
| 27651887 | Background | 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. |
| 20628774 | Background | 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. |
| 32802769 | Background | 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. |
| 36504246 | Background | 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. |
| 24578706 | Background | 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. |
| 25740308 | Background | 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. |
| 29430087 | 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. |