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OpenTrials
Completed

NCT Number: NCT03716349

Esthetics of Dental Composite and Adhesive System

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sensible tooth -responds to cold or electric pulp testing (done at screening)
  • Patient 18years of age or old
  • Current radiograph available (done at screening as needed)
  • A pair of the same type of restorations needed in the anterior esthetic/facial region (tooth #4-#13).

Exclusion criteria

  • Fewer than 20 teeth
  • Advanced untreated periodontal disease or recent periodontal surgery
  • Rampant uncontrolled caries activity
  • Bruxism or clenching and visible wear facets on the occlusal surface
  • Undergoing or in need of TMJ therapy
  • Known allergy to methacrylate-based materials or product ingredients
  • History of poor dental visit attendance
  • Not available for recall for at least 3 years
  • Fractured or visibly cracked tooth
  • Poor oral hygiene
  • Sensitive tooth or currently using desensitizing treatments, pastes or medicaments
  • Pregnant
  • Abutment teeth for prostheses
  • Teeth considered for restoration are non-vital, have had root canal therapy or been pulp capped
  • Teeth or supporting structures with any symptomatic pathology or extensive caries lesion
  • Individual supervised by PI or supervised by member of research team
  • Individual subordinate to the PI or subordinate to any member of the research team
  • Student or trainee under the direction of the PI or under the direction of a member of the research team

Treatment and study plan

Pulp vitality testing

Diagnostic Test

each tooth will be tested to determine if the pulp of the tooth responds to cold

Photos

Other

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

local and/or topical anesthetic

Drug

Local and/or topical anesthetic will be applied as necessary to the teeth or gingiva

rubber dam

Device

The area will be isolated with rubber dam isolation

tooth surface cleaned

Other

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.

enamel margins

Procedure

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).

Adhesive Systems

Procedure

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)

cavity preparation

Procedure

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.

Shade selection using Easy Shade 5

Other

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

Light Curing

Procedure

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.

Contoured and polished

Procedure

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)

Consent

Other

The consent form will be signed, copy will be provided to the patient

Health Questionnaire

Other

The health questionnaire will be completed at initial visit and updated at each follow-up visit

Xray

Radiation

When necessary a radiograph (xray) will be obtained

Release of medical information signed

Other

The release of medical information form will be signed

Oral Exam

Other

An Oral Exam will be completed

Teeth Assessment

Other

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.

Clinical Assessment

Other

A clinical assessment will be completed by the evaluators

Tokuyama Universal Bond

Device

Tokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system with Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan)

ScotchBond

Device

Scotch Bond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M)

Primary outcomes

  1. Patient Satisfaction of the Restoration's Appearance (Esthetics) Using the Visual Analog Scale

    Time frame: 5 years

    For each system, the Visual Analog Scale of 0-100 with 0 being a poor result and 100 being an excellent result will be used for the subject to voluntarily assess their satisfaction with each restoration's appearance.

Secondary outcomes

  1. Patient Satisfaction of the Restoration Appearance (Esthetics) Using the Verbal Rating Scale

    Time frame: 5 years

    For each system, the Verbal Rating Scale with 1 being a "Not at all Satisfied", 2 being "Somewhat Satisfied", 3 being "Satisfied" and 4 being "Very Satisfied" will be used for the subject to voluntarily assess their satisfaction with each restoration's appearance.

Sponsors and collaborators

Lead sponsor

Erica Teixeira

Other

Collaborators

  • Tokuyama Dental Corporation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2018
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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