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

Not Applicable

Not yet recruiting

• Conditions: Occlusal Caries
• Interventions: Other: Flowable Giomer; Other: Flowable Nano-filled composite; Other: Flowable Nano-filled composite with S-PRG barrier coat

• Registration Number: NCT06097143
• Lead Sponsor: Cairo University

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.

Detailed 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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-20
• Study First Posted: 2023-10-24
• Last Update Posted: 2023-10-24
• Study Start: 2023-11
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flowable Giomer	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).
Nano-Filled Flowable Composite	Flowable Nano-filled 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.
Nano-filled Flowable Composite with S-PRG barrier coat	Flowable Nano-filled 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.

Primary Outcome Measures

Name	Time	Method
Fracture and Retention of Material	T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up	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

Secondary Outcome Measures

Name	Time	Method
Occlusion and wear	T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up	World Dental Federation (FDI) criteria
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	World Dental Federation (FDI) criteria
Postoperative hypersensitivity/pulp status	T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up	World Dental Federation (FDI) criteria
Form and contour	T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up	World Dental Federation (FDI) criteria
Marginal Adaptation	T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up	World Dental Federation (FDI) criteria
Incidence of new carious lesions	T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up	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