Esthetics of Dental Composite and Adhesive System

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.

Conditions

• Cavities of Teeth

Interventions

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)

Sponsors & Collaborators

• Tokuyama Dental Corporation

  collaborator UNKNOWN

• Erica Teixeira

  lead OTHER

Principal Investigators

• Erica Teixeira, DDS, MS, PhD · University of Iowa College of Dentistry

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2025-11-20

Completion

2025-11-20

FDA Device

Yes

Countries

• United States

Study Locations