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

NCT06097143 | Completed

• 1 other identifier: Giomer Based Class I Cavities
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Occlusal Caries

Outcome Measures

Primary Outcomes (1)

• Fracture and Retention of Material

  World Dental Federation (FDI) criteria (Hickel et al.,2010) Scores: 1. Clinically excellent/ very good 1.1 No fractures/cracks 2. Clinically good 2.1 Small hairline crack 3. Clinically sufficient/ satisfactory 3.1 Two or more larger hairline cracks and/or material chip not affecting the marginal integrity or approximal contact 4. 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) 5. 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 Outcomes (6)

• Occlusion and wear

  T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up

• Marginal Adaptation

  T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up

• Form and contour

  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

  T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up

• Postoperative hypersensitivity/pulp status

  T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up

Study Arms (3)

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).

Other: Flowable Giomer

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.

Other: Flowable Nano-filled composite with S-PRG barrier coat

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.

Other: Flowable Nano-filled composite

Interventions

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.

Flowable Giomer

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.

Nano-filled Flowable Composite with S-PRG barrier coat

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.

Nano-Filled Flowable Composite

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Unilateral or Bilateral small Class I carious lesions
• Patients with good oral health
• Small Class I carious lesion in occlusal pits and fissures

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, Egypt

Location

Related Publications (10)

• 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.

  PMID: 36278658 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.

  PMID: 26266238 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.

  PMID: 21998768 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.

  PMID: 27651887 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.

  PMID: 20628774 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.

  PMID: 32802769 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.

  PMID: 36504246 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.

  PMID: 24578706 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.

  PMID: 25740308 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

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: Principle Investigator

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: December 15, 2023
• Primary Completion: June 19, 2025
• Study Completion: June 21, 2025
• Last Updated: September 29, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)