Esthetics of Dental Composite and Adhesive System

Erica Teixeira

Status

Active, not recruiting

Conditions

Cavities of Teeth

Treatments

Other: Photos

Procedure: enamel margins

Other: Shade selection using Easy Shade 5

Procedure: Light Curing

Radiation: xray

Other: Clinical Assessment

Procedure: Adhesive Systems

Diagnostic Test: Pulp vitality testing

Procedure: cavity preparation

Device: Tokuyama Universal Bond

Other: Oral Exam

Procedure: Contoured and polished

Other: tooth surface cleaned

Device: rubber dam

Other: Teeth Assessment

Drug: local and/or topical anesthetic

Other: Release of medical information signed

Other: Consent

Device: ScotchBond

Other: Health Questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT03716349

201809844

Details and patient eligibility

About

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.

Full description

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

37 participants in 2 patient groups

System A

Experimental group

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

Treatment:

Other: Health Questionnaire

Other: Release of medical information signed

Other: Consent

Drug: local and/or topical anesthetic

Other: Teeth Assessment

Device: rubber dam

Other: tooth surface cleaned

Other: Oral Exam

Procedure: Contoured and polished

Device: Tokuyama Universal Bond

Procedure: cavity preparation

Diagnostic Test: Pulp vitality testing

Procedure: Adhesive Systems

Other: Clinical Assessment

Radiation: xray

Procedure: Light Curing

Other: Shade selection using Easy Shade 5

Procedure: enamel margins

Other: Photos

System B

Active Comparator group

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.

Treatment:

Other: Health Questionnaire

Device: ScotchBond

Other: Release of medical information signed

Other: Consent

Drug: local and/or topical anesthetic

Other: Teeth Assessment

Device: rubber dam

Other: tooth surface cleaned

Other: Oral Exam

Procedure: Contoured and polished

Procedure: cavity preparation