Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Esthetics of Dental Composite and Adhesive System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716349
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
Tokuyama Dental Corporation
Information provided by (Responsible Party):
Erica Teixeira, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Cavities of Teeth 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 Device: ScotchBond Not Applicable

Detailed Description:

The aim of this (12-month; 36-month; and possible 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Esthetic Outcomes of a Newly Developed Dental Composite and Adhesive System: a Randomized Clinical Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2023

Arm Intervention/treatment
Experimental: 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, clinical assessment
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)

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




Primary Outcome Measures :
  1. Patient satisfaction of the restoration appearance (esthetics) VAS [ Time Frame: 3 years ]
    Patient satisfaction-VAS (Visual Analog Scale of 0-10 with 0 poor and 10 excellent result)


Secondary Outcome Measures :
  1. Patient satisfaction of the restoration appearance (esthetics) VRS [ Time Frame: 3 years ]
    Patient satisfaction- VRS (Verbal Rating Scale - very satisfied to not at all satisfied)

  2. Percent success of the restoration according to the esthetic appearance [ Time Frame: baseline, 1 year, 3 years ]
    Esthetic outcomes using the World Dental Federation instrument (FDI criteria- 5-likert scale criteria 1-best to 5 worst score) measured by the clinician's evaluators

  3. Percent success of the restoration according to biological aspects [ Time Frame: baseline, 1 year, 3 years ]
    using the World Dental Federation instrument (FDI criteria- 5-likert scale criteria 1-best to 5 worst score) by the clinician's evaluator

  4. Percent success of the restoration according to functional aspects [ Time Frame: baseline, 1 year, 3 years ]
    using the World Dental Federation instrument (FDI criteria- 5-likert scale criteria 1-best to 5 worst score) by the clinician's evaluator



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716349


Contacts
Layout table for location contacts
Contact: Erica Teixeira, DDS, MS, PhD 319-335-7270 Erica-teixeira@uiowa.edu
Contact: Karen Kluesner, RN 319-335-7377 karen-kluesner@uiowa.edu

Locations
Layout table for location information
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Erica Teixeira, DDS    319-335-7270    erica-teixeira@uiowa.edu   
Contact: Karen Kluesner, RN    3193357377    karen-kluesner@uiowa.edu   
Sponsors and Collaborators
Erica Teixeira
Tokuyama Dental Corporation
Investigators
Layout table for investigator information
Principal Investigator: Erica Teixeira, DDS, MS, PhD University of Iowa College of Dentistry

Layout table for additonal information
Responsible Party: Erica Teixeira, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03716349     History of Changes
Other Study ID Numbers: 201809844
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents