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

Study Overview
=================
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.

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

Conditions
-----------------
Occlusal Caries

Intervention / Treatment
-----------------
* Other: Flowable Giomer
* Other: Flowable Nano-filled composite with S-PRG barrier coat
* Other: Flowable Nano-filled composite


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flowable Giomer<br>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<br>* 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.<br>|
| Experimental: Nano-filled Flowable Composite with S-PRG barrier coat<br>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<br>* 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.<br>|
| Active Comparator: Nano-Filled Flowable Composite<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | 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 | 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 |