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Clinical Trials/NCT05499494
NCT05499494
Unknown
Not Applicable

Clinical Evaluation of Bioactive Injectable Resin Composite Versus Conventional Nanohybrid Composite in Posterior Restorations, 18 m Randomized Controlled Clinical Trial

Cairo University1 site in 1 country26 target enrollmentAugust 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Restoration Failure
Sponsor
Cairo University
Enrollment
26
Locations
1
Primary Endpoint
Change in the clinical performance
Last Updated
3 years ago

Overview

Brief Summary

The aim of the study is to evaluate the clinical performance of new bioactive injectable composite compared to nanohybrid composite during the restoration of posterior cavities

Detailed Description

Statement of the problem: Marginal defects of composite fillings are often thought to be caused by poor adaptation of the restorative material to the cavity wall. To avoid these defects, particularly in posterior teeth, the use of flowable composites has been advocated because of their ability to 'wet' and adapt well to cavity margins and walls. However, flowable composites have a lower filler content and usually weaker mechanical properties than conventional composites. The continued development of resin composites has led to formulations designed to further simplify the filling procedure, provide better mechanical properties, reduce the effect of polymerization shrinkage stresses and improve aesthetics. Recently, a new type of highly filled flowable composite has been developed. It is characterized by its high viscosity and is claimed to have improved mechanical properties not dissimilar from conventional composite restorative materials. This composite contains nano-sized filler particles, and due to its consistency, the material has been referred to as an 'injectable composite'. Rationale for carrying out the trial: The rationale of this study is to evaluate the mechanical performance of injectable composite resin against nanohybrid composites, because of its easy handling, time-saving, better margin adaptation, and the gain of extra mechanical properties at the same time.

Registry
clinicaltrials.gov
Start Date
August 2022
End Date
March 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hazem Mohamed El Deriny

Assistant lecturer at operative dentistry

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Participants:
  • Age range 20-50 years.
  • Males Or females .
  • Co-operative patients approving to participate in the trial.
  • class I or II carious lesions premolars and molars.
  • Vital upper or lower teeth with no signs of irreversible pulpitis and pulpal necrosis.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria

  • Participants:
  • Patients with general systemic illness.
  • Allergic history against any component of used material.
  • Disabilities.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of parafunctional habits.
  • Temporomandibular joint disorders.
  • Periapical pathology or signs of pulpal pathology.
  • Endodontically treated teeth.

Outcomes

Primary Outcomes

Change in the clinical performance

Time Frame: From baseline to 18 months

Measured using modified USPHS criteria

Study Sites (1)

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