Clinical Performance of Flowable Giomer Versus Nanofilled Composite in Conservative Occlusal Cavities

Occlusal Caries Clinical Trial

Official title:

Performance of Flowable Giomer Versus Nanofilled Flowable Composite With or Without Giomer Coat In Conservative Occlusal Cavities: 18 Months Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06097143
• Other study ID #: Giomer Based Class I Cavities
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

• Unilateral or Bilateral small Class I carious lesions

• Patients with good oral health

• Small Class I carious lesion in occlusal pits and fissures

Exclusion Criteria:

• Existing systemic diseases

• 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

Related Conditions & MeSH terms

• Occlusal Caries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Clin Oral Investig. 2023 Jan 6;: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture and Retention of Material	World Dental Federation (FDI) criteria (Hickel et al.,2010) Scores: Clinically excellent/ very good 1.1 No fractures/cracks; Clinically good 2.1 Small hairline crack; Clinically sufficient/ satisfactory 3.1 Two or more larger hairline cracks and/or material chip not affecting the marginal integrity or approximal contact; Clinically unsatisfactory (but repairable) 4.1 Material chip fractures which damage marginal quality or approximal contacts 4.2 Bulk fractures with partial loss (less than half of the restoration); Clinically poor (replacement necessary) 5.1 Partial or complete loss of restoration or multiple fractures	T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up
Secondary	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
Secondary	Marginal Adaptation	World Dental Federation (FDI) criteria	T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up
Secondary	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
Secondary	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
Secondary	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
Secondary	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