NCT03716349

Esthetics of Dental Composite and Adhesive System

Esthetic Outcomes of a Newly Developed Dental Composite and Adhesive System: a Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Erica Teixeira · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To compare a newly developed filling composite to a current filling composite system. Two restorations will be placed in each subject, one using system A and one using system B. The first system listed in the randomization pair will be placed on first tooth (#4-#13), and the second system on 2nd tooth (#4-#13). The same three researchers will be responsible for placement of all the restorations.

Detailed description

The aim of this (12-month; 36-month; 60-month) randomized controlled clinical trial is to evaluate and compare the esthetic outcomes and patient satisfaction of a simplified newly developed dental composite system (system A)for the esthetic region to a nanohybrid composite system (Filtek Supreme Ultra-system B) placed in class III, IV and V lesions. Even though dental composite systems have been used extensively for the anterior region, clinicians face challenges with shade selection and longevity of the material over the years. This new system has been developed to improve the esthetic outcomes and patient satisfaction by enhancing the blending capability of the material. Dental composite systems have been used for 50 years as state of art materials to restore the anterior region. Significant development has occurred regarding the composition and structure of dental composites, improving the longevity of these restorations; however, clinicians are faced with the challenge of selecting the most adequate shade and restorative technique to reproduce missing tooth structure. Depending on the size of the cavity preparation, a single layer of material or multiple layers might be needed to reproduce dentin and enamel. Different dental composite systems offer multiple body, dentin, and enamel shades. Therefore, clinicians are faced with the challenge of recreating nature using this material. Different devices, such as spectrophotometers have been introduced on the market for shade selection. However, one of the most important aspects when placing anterior composites is the esthetic outcome based on the patient's assessment. Therefore, this study will evaluate the esthetic outcomes of a simplified and a conventional dental composite system based on the provider's and patient's assessment.

Conditions

• Cavities of Teeth

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pulp vitality testing	each tooth will be tested to determine if the pulp of the tooth responds to cold
OTHER	Photos	Photos of teeth (Photos will be taken with a DSLR camera settings will be determined with optimal settings) and captured periodically throughout the study. Photographs will be made of the cavity preparation. Photographs will be made post-operatively
DRUG	local and/or topical anesthetic	Local and/or topical anesthetic will be applied as necessary to the teeth or gingiva
DEVICE	rubber dam	The area will be isolated with rubber dam isolation
OTHER	tooth surface cleaned	The tooth surface will be cleaned with flour of pumice on a prophy cup only, cavity preparation will be performed as usual for caries removal.
PROCEDURE	enamel margins	Enamel margins will be beveled with a long flame diamond bur (8863.314.012 Komet) at 45 degrees to the external tooth surface to achieve the desired bevel length. Along with the use of the diamond bur, infinite invisible margins will be created by contouring and smoothing with a dark orange Sof-LexTM extra-thin contouring and polishing disc (3M).
PROCEDURE	Adhesive Systems	Adhesive systems will be applied according to manufacturer's instructions and selective etching of the enamel will be performed. The dental composite will be incrementally placed using a two- layer or one-layer technique based on the cavity size and light-cured (detailed adhesive instruction sheet will be chairside for reference)
PROCEDURE	cavity preparation	The technique to be used will be determined by the size of the final cavity preparation. For small preparations a one-layer technique will be used. No backing material is necessary for the Tokuyama system, Filtek Supreme Ultra will be determined by manufacturer's wheel. A two-layer technique will be used for a large cavity preparation. Large cavity preparation is defined as being 4mm in length or more and/or at least 2mm in depth.
OTHER	Shade selection using Easy Shade 5	A1 (shade determined by Easy Shade 5), ECM-001/Backing material, A1E/A2D (shade will be selected by shade wheel) A4 (shade determined by Easy shade5), ECM-001/Backing material, A3E/A6D (shade will be selected by shade wheel
PROCEDURE	Light Curing	A Valo Grand curing unit (Ultradent) with an exitant irradiance with no less than 500 and no greater than 1500 mW/cm2 as measured with MARC Light Collector will be used in standard mode to deliver the required radiant exposure J/cm2 for adhesive and dental composite increments.
PROCEDURE	Contoured and polished	The restoration will be contoured and polished with - Long flame diamond bur (8863.314.012 Komet), Sof-Lex Medium (orange) Contouring and Polishing Discs (3M), Green Jiffy cup pre-polisher (Ultradent Products, Inc.), Blue and grey silicone points composite polisher gloss plus finisher (Kerr Hawe)
OTHER	Consent	The consent form will be signed, copy will be provided to the patient
OTHER	Health Questionnaire	The health questionnaire will be completed at initial visit and updated at each follow-up visit
RADIATION	xray	When necessary a radiograph (xray) will be obtained
OTHER	Release of medical information signed	The release of medical information form will be signed
OTHER	Oral Exam	An Oral Exam will be completed
OTHER	Teeth Assessment	The teeth assessment by subject will be completed using the Visual Analog Scale (VAS) and Verbal Rating Scale (VRS) at the follow-up visits 1 month after restoration, 1 year, 2 years and 3 years post restoration.
OTHER	Clinical Assessment	A clinical assessment will be completed by the evaluators
DEVICE	Tokuyama Universal Bond	Tokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system with Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan)
DEVICE	ScotchBond	Scotch Bond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M)

Timeline

• Start date: 2019-01-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2018-10-23
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study