NCT04019145

Clinical Evaluation of Fiber Reinforced Resin Composite Base Versus Incremental Packing of Nanohybrid Resin Composite

Clinical Evaluation of Fiber Reinforced Bulk Fill Resin Composite Versus Incremental Packing of Nanohybrid Resin Composite in Restoration of Deep Proximal Lesions of Permanent Posterior Molars: A Randomized Controlled Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Caries Class II

Interventions

Type	Name	Description
DRUG	EverX Posterior	fiber reinforced bulk fill resin composite
DRUG	Resins, Composite	incremental packing of Nanohybrid Resin composite

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-09-01
• Completion: 2021-09-30
• First posted: 2019-07-15
• Last updated: 2021-11-09

Locations

1 site across 1 country: Egypt