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

NCT04475172 | Unknown

• 1 other identifier: ECPSAFCsCFC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative sensitivity

  at baseline and 3 months after starting treatment .

Study Arms (2)

Fusio™ Flowable Self-Adhesive Flowable Composite

EXPERIMENTAL

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

Conventional flowable composite [Tetric Evo Flow (FF)].

ACTIVE COMPARATOR

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

Interventions

Self-Adhesive Flowable Composite COMBINATION_PRODUCT

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.

Also known as: Fusio™ Flowable Self-Adhesive Flowable Composite

Conventional flowable composite [Tetric Evo Flow (FF)].; Fusio™ Flowable Self-Adhesive Flowable Composite

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 17, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 17, 2020

Record last verified: 2020-07