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

Cairo University (CU)

Status: Completed

Conditions: Occlusal Caries

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06097143

Giomer Based Class I Cavities

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 3 patient groups

Flowable Giomer

Experimental group

Description:

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).

Treatment:

Other: Flowable Giomer

Nano-filled Flowable Composite with S-PRG barrier coat

Experimental group

Description:

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.

Treatment:

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

Nano-Filled Flowable Composite

Active Comparator group

Description:

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.

Treatment:

Other: Flowable Nano-filled composite