Esthetics of Dental Composite and Adhesive System

N/AActive Not RecruitingNCT03716349

Erica Teixeira37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cavities of Teeth

Interventions

Pulp vitality testingDIAGNOSTIC_TEST

each tooth will be tested to determine if the pulp of the tooth responds to cold

PhotosOTHER

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

local and/or topical anestheticDRUG

Local and/or topical anesthetic will be applied as necessary to the teeth or gingiva

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Iowa

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Patient satisfaction of the restoration appearance (esthetics) VAS

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

Time frame: 3 years and 5 years

Secondary Outcomes

Patient satisfaction of the restoration appearance (esthetics) VRS

Patient satisfaction- VRS (Verbal Rating Scale - very satisfied to not at all satisfied)

Time frame: 3 years and 5 years

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

Time frame: baseline, 1 year, 3 years, 5 years

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

Time frame: baseline, 1 year, 3 years, 5 years

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

Time frame: baseline, 1 year, 3 years, 5 years

Data from ClinicalTrials.gov

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