Occlusal Caries
Conditions
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.
Interventions
OTHERFlowable 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.
OTHERFlowable 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.
OTHERFlowable 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Egypt
Outcome results
None listed