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

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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries
• Intervention / Treatment: Combination product: Self-Adhesive Flowable Composite

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fusio™ Flowable Self-Adhesive Flowable Composite; 2-Cavity preparation steps: patients will be given local anesthesia as required,the operative field will be isolated with rubber dam before starting.; Conventional design Class V cavity will be prepared on the buccal surface of tooth by No. #330 bur (0.8 mm in diameter and 1.6 mm in length) , tooth surfaces will be kept moist to protect them against dehydration.; 2% chlorhexidine gluconate disinfecting solution .; wash the dentin surface with water spray and air dry with maximum air pressure for 5 s. A) Intervention: Fusio™ Flowable (Self adhesive flowable composite): Simply syringe into the preparation 1 mm increments, agitate with tip or brush for 20 s, and light-cure.No need for an etchant or an adhesive.	Combination product: Self-Adhesive Flowable Composite; Fusio Self-Adhesive Flowable Composite combines the benefits of adhesive and restorative technology into one product . Immediately upon application Fusio conditions, bonds, and seals without the need for an etchant or an adhesive. 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.; Other Names: Fusio™ Flowable Self-Adhesive Flowable Composite
Active Comparator: Conventional flowable composite [Tetric Evo Flow (FF)].; Tetric Evo Flow (Conventional flowable composite): After cleaning cavities, apply conditioning material (phosphoric acid etching 37% ) and apply bonding agent (ExciTE® F) according to the instructions for use of the product.; Apply Tetric EvoFlow in layers of 1mm. Polymerize each layer separately following the instructions for use of this product. . Hold the light emission window as closely as possible to the surface of the restorative material. All 20 Class V restorations will be prepared, restored, finished, and polished by one operator. Each of the 10 patients had one (FL) restoration and the other restoration will be filled with (FF).	Combination product: Self-Adhesive Flowable Composite; Fusio Self-Adhesive Flowable Composite combines the benefits of adhesive and restorative technology into one product . Immediately upon application Fusio conditions, bonds, and seals without the need for an etchant or an adhesive. 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.; Other Names: Fusio™ Flowable Self-Adhesive Flowable Composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal integrity of Class V restorations	clinical evaluation according to Modified USPHS Criteria (Bayne and Schmalz, 2005) unit of measurement :Alfa, Bravo,charlie and Delta	Clinical Evaluation of Marginal integrity after 6 months after starting treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative sensitivity	clinical evaluation according to Modified United States Public Health Service Criteria (Bayne and Schmalz, 2005)	at baseline and 3 months after starting treatment .

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: ECPSAFCsCFC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No