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| Name | Class |
|---|---|
| Tokuyama Dental Corporation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulp vitality testing | Diagnostic Test | each tooth will be tested to determine if the pulp of the tooth responds to cold |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction of the Restoration Appearance (Esthetics) Using the Verbal Rating Scale | 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. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica Teixeira, DDS, MS, PhD | University of Iowa College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | System A | Tokuyama Universal Single Component Self-Etching 1-step adhesive system with Tokuyama supra-nanofilled dental composite was randomly assigned to the left or right side maxillary tooth in a split-mouth randomized design. |
| FG001 | System B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2025 |
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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.
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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.
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| 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 |
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| local and/or topical anesthetic | Drug | Local and/or topical anesthetic will be applied as necessary to the teeth or gingiva |
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| rubber dam | Device | The area will be isolated with rubber dam isolation |
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| 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. |
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| 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) |
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| 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. |
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| 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) |
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| Consent | Other | The consent form will be signed, copy will be provided to the patient |
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| Health Questionnaire | Other | The health questionnaire will be completed at initial visit and updated at each follow-up visit |
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| xray | Radiation | When necessary a radiograph (xray) will be obtained |
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| Release of medical information signed | Other | The release of medical information form will be signed |
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| Oral Exam | Other | An Oral Exam will be completed |
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| 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. |
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| Clinical Assessment | Other | A clinical assessment will be completed by the evaluators |
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| 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) |
|
ScotchBond Universal one-step adhesive system with Filtek Supreme Ultra, nanofilled dental composite (3M) was randomly assigned to the left or right side maxillary tooth in a split-mouth randomized design. |
| COMPLETED | Completion of the 5-Year Visit |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomization of Participants' Teeth to System A or System B | 1 Participant has 2 teeth that were enrolled in the study. System A was randomly assigned to one of the teeth, and System B was randomly assigned to the other tooth in this split-mouth model study design. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The discrepancy is that for System A, one participant needed to have treatment performed on a tooth that had been assigned to System A. Therefore, this tooth needed to be removed from the study, which resulted in a decrease by one in the number of participants analyzed for system A and the number of teeth analyzed for System A. | Posted | Mean | Standard Deviation | units on a scale | 5 years | Teeth | Teeth |
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| Secondary | Patient Satisfaction of the Restoration Appearance (Esthetics) Using the Verbal Rating Scale | 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. | The discrepancy is that for System A, one participant needed to have treatment performed on a tooth that had been assigned to System A. Therefore, this tooth needed to be removed from the study, which resulted in a decrease by one in the number of participants analyzed for system A and the number of teeth analyzed for System A. | Posted | Mean | Standard Deviation | units on a scale | 5 years |
|
5 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | System A | 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 and clinical assessment at periodic timepoints. | 0 | 36 | 0 | 36 | 0 | 36 |
| EG001 | System B | 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. | 0 | 36 | 0 | 36 | 0 | 36 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erica Teixeira | University of Iowa College of Dentistry | (319) 335-7270 | erica-teixeira@uiowa.edu |
| Feb 12, 2026 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D016733 | Rubber Dams |
| D032962 | Consent Forms |
| D000073222 | Patient Health Questionnaire |
| D014965 | X-Rays |
| D003945 | Diagnosis, Oral |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D003748 | Dental Equipment |
| D003813 | Dentistry |
| D004864 | Equipment and Supplies |
| D007258 | Informed Consent |
| D007603 | Jurisprudence |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D003625 | Data Collection |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011795 | Surveys and Questionnaires |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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| >=65 years |
|
| System B |
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. |
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