Esthetics of Dental Composite and Adhesive System

NCT03716349 | Completed Results FDA Device

• 1 other identifier: 201809844
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  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.

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (2)

System A

EXPERIMENTAL

Tokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system w/Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan), informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. teeth assessment, clinical assessment

Diagnostic Test: Pulp vitality testing; Other: Photos; Drug: local and/or topical anesthetic; Device: rubber dam; Other: tooth surface cleaned; Procedure: enamel margins; Procedure: Adhesive Systems; Procedure: cavity preparation; Other: Shade selection using Easy Shade 5; Procedure: Light Curing; Procedure: Contoured and polished; Other: Consent; Other: Health Questionnaire; Radiation: xray; Other: Release of medical information signed; Other: Oral Exam; Other: Teeth Assessment; Other: Clinical Assessment; Device: Tokuyama Universal Bond

System B

ACTIVE COMPARATOR

ScotchBond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M) will randomly be applied to the other tooth informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. teeth assessment and clinical assessment at periodic timepoints.

Diagnostic Test: Pulp vitality testing; Other: Photos; Drug: local and/or topical anesthetic; Device: rubber dam; Other: tooth surface cleaned; Procedure: enamel margins; Procedure: Adhesive Systems; Procedure: cavity preparation; Other: Shade selection using Easy Shade 5; Procedure: Light Curing; Procedure: Contoured and polished; Other: Consent; Other: Health Questionnaire; Radiation: xray; Other: Release of medical information signed; Other: Oral Exam; Other: Teeth Assessment; Other: Clinical Assessment; Device: ScotchBond

Interventions

Pulp vitality testing DIAGNOSTIC_TEST

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

System A; System B

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

System A; System B

local and/or topical anesthetic DRUG

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

System A; System B

rubber dam DEVICE

The area will be isolated with rubber dam isolation

System A; System B

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.

System A; System B

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).

System A; System B

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)

System A; System B

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.

System A; System B

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

System A; System B

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.

System A; System B

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)

System A; System B

Consent OTHER

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

System A; System B

Health Questionnaire OTHER

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

System A; System B

xray RADIATION

When necessary a radiograph (xray) will be obtained

System A; System B

Release of medical information signed OTHER

The release of medical information form will be signed

System A; System B

Oral Exam OTHER

An Oral Exam will be completed

System A; System B

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.

System A; System B

Clinical Assessment OTHER

A clinical assessment will be completed by the evaluators

System A; System B

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)

System A

ScotchBond DEVICE

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

System B

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Erica Teixeira: lead
• Tokuyama Dental Corporation: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Anesthetics, Local; Rubber Dams; Consent Forms; Patient Health Questionnaire; X-Rays; Diagnosis, Oral

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Dental Equipment; Dentistry; Equipment and Supplies; Informed Consent; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations; Records; Organization and Administration; Health Services Administration; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Surveys and Questionnaires; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Public Health; Environment and Public Health; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Results Point of Contact

• Title: Erica Teixeira
• Organization: University of Iowa College of Dentistry

erica-teixeira@uiowa.edu

(319) 335-7270

Study Officials

• Erica Teixeira, DDS, MS, PhD

  University of Iowa College of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The statistician will prepare a randomization list of A-B and B-A pairs to be applied sequentially as subjects receive restorations. 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 random sequence will be individually placed in opaque, consecutively numbered and sealed envelopes, which should be opened by the operator immediately before the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Simple randomization will be used for assignment of the treatment groups. Randomization: Two restorations will be placed in each subject, one using system A and one using system B.

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 23, 2018
• Study Start: January 1, 2019
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)