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A clinical trial, comparing two different incrementation techniques in the restoration of proximal caries in permanent posterior teeth . One utilizes a fiber reinforced bulk fill base material, followed by an occlusal nanohybrid capping layer. The other utilizes incremental packing of nanohybrid resin composite material to fill the whole cavity.
The aim of this study is to conduct an RCT to evaluate the clinical performance of the fiber reinforced bulk fill resin composite in comparison to incremental packing of nanohybrid resin composite.
Examination and selection of all patients will be done according to inclusion and exclusion criteria. Diagnosis of patients' chief complaint and teeth that will be involved in this study will be done. Teeth are to be chosen according to standardized radiographic examination. Teeth should have proximal, primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber.
A Class II cavity will be prepared after local anesthesia has been given as required. The cavity will be prepared using a high-speed hand-piece with air and water coolant and diamond burs of different sizes. Sharp excavators will allow accessible removal of soft carious lesions will be used. Any tooth that will suffer from pulpal exposure will be excluded from the study. Finishing of the cavity walls will be done using a fine-grit, yellow coded, diamond bur.
Rubber dam isolation will be done.
Sectional matricing and wedging will be done. Followed by, placement of restorative material according to the randomization sequence.
A closed centripetal technique will be utilized, where a proximal wall will be built using nanohyrbid resin composite first, followed by filling of cavity with bulk-fill fiber reinforced resin composite material in increments of 3-4mm, as required to end up with leaving an occlusal space on top of at least 2mm. Then, an occlusal increment of nanohybrid resin composite will be applied. Finally finishing and occlusal adjustment will be done under water spray by using superfine diamond burs. Polishing will be done using pre-impregnated rubber cups. Materials will be manipulated according to manufacturer instructions.
A closed centripetal, oblique incrementation technique will be used to completely fill the whole cavity. Increments should be of 2mm thickness or less and should be placed obliquely from the cavity walls. Then finishing and occlusal adjustment will be done under water spray by using superfine diamond burs. Polishing will be done using pre-impregnated rubber cups. Materials will be manipulated according to manufacturer instructions
Outcome Measuring Device: modified USPHS criteria .
Primary Outcomes:
Mechanical evaluation:
Fracture and Retention Marginal integrity Marginal Discoloration Anatomic Form Surface Texture Proximal Contact Radiographic Examination
Secondary Outcomes:
Biological evaluation:
Postoperative Sensitivity Recurrent Caries
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber Reinforced bulk fill resin composite | Experimental | Fiber reinforced bulk fill resin composite dentine substitute, capped occlusally and proximally (closed centripetal technique) by nanohybrid resin composite. |
|
| nanohybrid resin composite incrementation | Active Comparator | Nanohybrid resin composite layering to fill the whole cavity, using closed centripetal technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EverX Posterior | Drug | fiber reinforced bulk fill resin composite |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical outcome according to USPHS criteria | fracture or retention, marginal integrity, marginal discoloration, anatomic form, proximal contact, radiographic examination and surface texture | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biological outcome according to USPHS criteria | postoperative sensitivity and recurrent caries | 12 months |
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Inclusion Criteria:
Patient-related criteria:
Tooth related criteria:
Exclusion Criteria:
Patient-related criteria:
Tooth related criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olfat Hassanein, Professor | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
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| ID | Term |
|---|---|
| C000618653 | EverX Posterior |
| D003188 | Composite Resins |
| ID | Term |
|---|---|
| D012117 | Resins, Synthetic |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Resins, Composite | Drug | incremental packing of Nanohybrid Resin composite |
|
|
| D003764 |
| Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |