Ignite Creation Date:
2024-05-06 @ 1:25 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04019145
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2019-07-10
Brief Title:
Clinical Evaluation of Fiber Reinforced Resin Composite Base Versus Incremental Packing of Nanohybrid Resin Composite
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
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
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 23 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
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 23 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None