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Esthetics of Dental Composite and Adhesive System

Primary Purpose

Cavities of Teeth

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulp vitality testing
Photos
local and/or topical anesthetic
rubber dam
tooth surface cleaned
enamel margins
Adhesive Systems
cavity preparation
Shade selection using Easy Shade 5
Light Curing
Contoured and polished
Consent
Health Questionnaire
xray
Release of medical information signed
Oral Exam
Teeth Assessment
Clinical Assessment
Tokuyama Universal Bond
ScotchBond
Sponsored by
Erica Teixeira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cavities of Teeth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

System A

System B

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Patient satisfaction of the restoration appearance (esthetics) VAS
Patient satisfaction-VAS (Visual Analog Scale of 0-10 with 0 poor and 10 excellent result)

Secondary Outcome Measures

Patient satisfaction of the restoration appearance (esthetics) VRS
Patient satisfaction- VRS (Verbal Rating Scale - very satisfied to not at all satisfied)
Percent success of the restoration according to the esthetic appearance
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
Percent success of the restoration according to biological aspects
using the World Dental Federation instrument (FDI criteria- 5-likert scale criteria 1-best to 5 worst score) by the clinician's evaluator
Percent success of the restoration according to functional aspects
using the World Dental Federation instrument (FDI criteria- 5-likert scale criteria 1-best to 5 worst score) by the clinician's evaluator

Full Information

First Posted
October 1, 2018
Last Updated
July 6, 2023
Sponsor
Erica Teixeira
Collaborators
Tokuyama Dental Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03716349
Brief Title
Esthetics of Dental Composite and Adhesive System
Official Title
Esthetic Outcomes of a Newly Developed Dental Composite and Adhesive System: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erica Teixeira
Collaborators
Tokuyama Dental Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cavities of Teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
System A
Arm Type
Experimental
Arm Description
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
Arm Title
System B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pulp vitality testing
Intervention Description
each tooth will be tested to determine if the pulp of the tooth responds to cold
Intervention Type
Other
Intervention Name(s)
Photos
Intervention 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
Intervention Name(s)
local and/or topical anesthetic
Intervention Description
Local and/or topical anesthetic will be applied as necessary to the teeth or gingiva
Intervention Type
Device
Intervention Name(s)
rubber dam
Intervention Description
The area will be isolated with rubber dam isolation
Intervention Type
Other
Intervention Name(s)
tooth surface cleaned
Intervention 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
Intervention Name(s)
enamel margins
Intervention 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
Intervention Name(s)
Adhesive Systems
Intervention 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
Intervention Name(s)
cavity preparation
Intervention 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
Intervention Name(s)
Shade selection using Easy Shade 5
Intervention 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
Intervention Name(s)
Light Curing
Intervention 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
Intervention Name(s)
Contoured and polished
Intervention 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
Intervention Name(s)
Consent
Intervention Description
The consent form will be signed, copy will be provided to the patient
Intervention Type
Other
Intervention Name(s)
Health Questionnaire
Intervention Description
The health questionnaire will be completed at initial visit and updated at each follow-up visit
Intervention Type
Radiation
Intervention Name(s)
xray
Intervention Description
When necessary a radiograph (xray) will be obtained
Intervention Type
Other
Intervention Name(s)
Release of medical information signed
Intervention Description
The release of medical information form will be signed
Intervention Type
Other
Intervention Name(s)
Oral Exam
Intervention Description
An Oral Exam will be completed
Intervention Type
Other
Intervention Name(s)
Teeth Assessment
Intervention 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
Intervention Name(s)
Clinical Assessment
Intervention Description
A clinical assessment will be completed by the evaluators
Intervention Type
Device
Intervention Name(s)
Tokuyama Universal Bond
Intervention 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
Intervention Name(s)
ScotchBond
Intervention Description
Scotch Bond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M)
Primary Outcome Measure Information:
Title
Patient satisfaction of the restoration appearance (esthetics) VAS
Description
Patient satisfaction-VAS (Visual Analog Scale of 0-10 with 0 poor and 10 excellent result)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Patient satisfaction of the restoration appearance (esthetics) VRS
Description
Patient satisfaction- VRS (Verbal Rating Scale - very satisfied to not at all satisfied)
Time Frame
3 years
Title
Percent success of the restoration according to the esthetic appearance
Description
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
Time Frame
baseline, 1 year, 3 years
Title
Percent success of the restoration according to biological aspects
Description
using the World Dental Federation instrument (FDI criteria- 5-likert scale criteria 1-best to 5 worst score) by the clinician's evaluator
Time Frame
baseline, 1 year, 3 years
Title
Percent success of the restoration according to functional aspects
Description
using the World Dental Federation instrument (FDI criteria- 5-likert scale criteria 1-best to 5 worst score) by the clinician's evaluator
Time Frame
baseline, 1 year, 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica Teixeira, DDS, MS, PhD
Organizational Affiliation
University of Iowa College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Esthetics of Dental Composite and Adhesive System

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