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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04475172
• Other study ID #: ECPSAFCsCFC
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: October 2021

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 .