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Clinical Trials/NCT04475172
NCT04475172
Unknown
Not Applicable

Evaluation Of Clinical Performance of Self-adhering Flowable Composite vs Conventional Flowable Composite in Cervical Carious Lesions: A Randomized Clinical Trial

Cairo University0 sites20 target enrollmentOctober 2020
ConditionsDental Caries

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries
Sponsor
Cairo University
Enrollment
20
Primary Endpoint
Marginal integrity of Class V restorations
Last Updated
5 years ago

Overview

Brief Summary

This clinical trial will be conducted to compare the clinical performance of a new self-adhering flowable composite in restoring CLs compared to conventional flowable composite in geriatric patients over 12 months.

Detailed Description

Recently, self-adhesive flowable composites (SAFCs) have been introduced as a new class of restorative material in adhesive dentistry. Today, there are only two available products in the market for clinical use: Vertise Flow and Fusio Liquid Dentin. Self-adhering flowable composite was introduced to address the time-consuming procedure used with traditional materials Their resin matrix contains acidic functional adhesive monomers mediating bonding with dental hard tissues and, therefore, separate etching and additional bonding are not required. SAFCs have been mainly advertised for the restoration of small Class I, Class III and V cavities, for cavity lining, and for use as a pit and fissure sealant. Self-adhering flowable composite combines the merits of both adhesive and restorative material technologies in one product, bringing novel horizons to restorative techniques, as it is a direct composite resin restorative material that has an adhesive resin together with a flowable composite resin. It is based on the bonding technology that uses glycerophosphate dimethacrylate(GPDM)to etch enamel and dentin, and hydroxyethyl methacrylate (HEMA) to enhance wetting and penetration by resin into dentin. This resin bonds chemically between the phosphate groups of a GPDM monomer and the hydroxyapatite of tooth structure and, also, micromechanically between the polymerized monomers of the self-adhering flowable composite resin and the collagen fibers and smear layer of dentin.

Registry
clinicaltrials.gov
Start Date
October 2020
End Date
October 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatheya Mansour Atifa Elshnawy

principal investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Cervical Class V carious lesions in anterior and premolars teeth.
  • Age above 60 years.
  • Males and females.

Exclusion Criteria

  • • patient less than 60 years with disabilities, systemic disease, severe medical conditions, rampant caries, and xerostomia.
  • In addition, teeth with potential prosthodontics restoration and nonvital or endodontically treated teeth.

Outcomes

Primary Outcomes

Marginal integrity of Class V restorations

Time Frame: Clinical Evaluation of Marginal integrity after 6 months after starting treatment.

clinical evaluation according to Modified USPHS Criteria (Bayne and Schmalz, 2005) unit of measurement :Alfa, Bravo,charlie and Delta

Secondary Outcomes

  • Postoperative sensitivity(at baseline and 3 months after starting treatment .)

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