Study: NCT03716349

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Pulp vitality testing
Description: each tooth will be tested to determine if the pulp of the tooth responds to cold

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Pulp vitality testing
Description: each tooth will be tested to determine if the pulp of the tooth responds to cold

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Photos
Description: 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

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Photos
Description: 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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: local and/or topical anesthetic
Description: Local and/or topical anesthetic will be applied as necessary to the teeth or gingiva

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: local and/or topical anesthetic
Description: Local and/or topical anesthetic will be applied as necessary to the teeth or gingiva

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: rubber dam
Description: The area will be isolated with rubber dam isolation

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: rubber dam
Description: The area will be isolated with rubber dam isolation

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: tooth surface cleaned
Description: 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.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: tooth surface cleaned
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: enamel margins
Description: 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).

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: enamel margins
Description: 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).

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Adhesive Systems
Description: 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)

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Adhesive Systems
Description: 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)

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: cavity preparation
Description: 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.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: cavity preparation
Description: 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.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Shade selection using Easy Shade 5
Description: 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

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Shade selection using Easy Shade 5
Description: 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

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Light Curing
Description: 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.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Light Curing
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Contoured and polished
Description: 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)

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Contoured and polished
Description: 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)

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Consent
Description: The consent form will be signed, copy will be provided to the patient

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Consent
Description: The consent form will be signed, copy will be provided to the patient

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Health Questionnaire
Description: The health questionnaire will be completed at initial visit and updated at each follow-up visit

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Health Questionnaire
Description: The health questionnaire will be completed at initial visit and updated at each follow-up visit

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: xray
Description: When necessary a radiograph (xray) will be obtained

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: xray
Description: When necessary a radiograph (xray) will be obtained

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Release of medical information signed
Description: The release of medical information form will be signed

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Release of medical information signed
Description: The release of medical information form will be signed

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Oral Exam
Description: An Oral Exam will be completed

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Oral Exam
Description: An Oral Exam will be completed

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Teeth Assessment
Description: 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.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Teeth Assessment
Description: 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.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Clinical Assessment
Description: A clinical assessment will be completed by the evaluators

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Clinical Assessment
Description: A clinical assessment will be completed by the evaluators

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Tokuyama Universal Bond
Description: Tokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system with Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan)

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: ScotchBond
Description: Scotch Bond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M)