Caries Class II
Conditions
Keywords
Low-shrinkage Giomer, Nano-hybrid composite, Revised FDI criteria
Brief summary
A clinical trial, comparing the clinical performance and occlusal wear resistance of two different restorative materials in restoring proximal caries in permanent posterior teeth. One is based on giomer technology and the other is nano-hybrid resin composite.
Detailed description
The aim of this study is to assess clinical performance and occlusal wear resistance of low shrinkage Giomer and Nanohybrid Resin Composite in proximal restorations using revised FDI (World Dental Federation) criteria and digital intra-oral scanner. Two different restorative materials will be evaluated after two years for fracture, retention and occlusal wear. Furthermore, the rest of the revised FDI Criteria including functional (marginal adaptation, proximal contact point, form and contour, occlusion and occlusal wear) , biological (caries at restoration margin (CAR), dental hard tissue defects at restoration margin and postoperative hypersensitivity/pulp status) and esthetic properties (surface luster and surface texture, marginal staining and color match) will be also evaluated. The first material is based on the giomer technology which is a true hybrid between nano-hybrid resin composite and glass ionomer. The comparator will be a nano-hybrid resin composite. Examination and selection of all patients will be done. Teeth with proximal, primary carious lesions will be selected. Rubber dam isolation will be done followed by preparation of Class II cavities and placement of restorative material according to the randomization sequence. Low-shrinkage bioactive material will be applied according to the manufacturer's instructions. For the comparator group, nano-hybrid resin composite will be also applied according to the manufacturer's instructions. Restorations will evaluated at baseline, after six, 12, 18 and 24 months.
Interventions
low shrinkage bioactive material Giomer
DRUG3M Filtek Z250 XT Universal
Universal Nano-hybrid composite
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 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion criteria for patients * Patient's age ranging from 19-30 * Good oral hygiene. * Patients who have stable occlusion. * Patients who could be present for further periodic follow-ups. * Possibility for application of rubber dam during restoration. * Patient compliance. * Inclusion criteria for Teeth * Vital first and second molars, with compound Class II lesions. * The selected teeth should be in occlusion with natural dentition and having proximal contact with adjacent teeth. * Healthy periodontium.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional properties (F1) Fracture of material and retention according to revised FDI (World Dental Federation) criteria. Measured by visual examination and short air drying. | 24 months | Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative occlusal restoration wear by Digital Intra-oral scanner and Geometrical subtraction software. | 24 months. | Method of aggregation is Mean (SD) (parametric) or Median (Range) (Non-parametric). Measuring unit is Microns. |
| Functional properties according to revised FDI (World Dental Federation) criteria. | 24 months. | Functional properties: F2: Marginal adaptation measured by visual examination, short air drying, 250 μm probe. F3:Proximal contact point measured by visual examination and 25/50/100 μm blades. F4: Form and contour measured by visual examination. F5: Occlusion and occlusal wear measured by visual examination and articulation paper. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient). |
| Biological properties according to revised FDI criteria. | 24 months. | Biological properties: B1: Caries at restoration margin (CAR) measured by visual examination, short air drying, and 250 μm probe. B2: Dental hard tissue defects at restoration margin measured by visual examination. B3: Postoperative hypersensitivity reported by patient and pulp status tested with cold stimulus. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient). |
| Aesthetic properties according to revised FDI criteria. | 24 months. | Aesthetic properties: A1: Surface luster and surface texture measured by visual examination and short air drying. A2: Marginal staining measured by visual examination and short air drying. A3: color match measured by visual examination. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient). |
Contacts
Primary ContactMarwa AbdelHafez, MS.C
Outcome results
None listed