Clinical trial NCT03716349: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cavities of Teeth
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Tokuyama Dental Corporation
First posted: 2018-10-23
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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; 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.

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

Primary outcomes:
measure: Patient satisfaction of the restoration appearance (esthetics) VAS
timeFrame: 3 years and 5 years
Secondary outcomes:
measure: Patient satisfaction of the restoration appearance (esthetics) VRS
timeFrame: 3 years and 5 years
measure: Percent success of the restoration according to the esthetic appearance
timeFrame: baseline, 1 year, 3 years, 5 years
measure: Percent success of the restoration according to biological aspects
timeFrame: baseline, 1 year, 3 years, 5 years
measure: Percent success of the restoration according to functional aspects
timeFrame: baseline, 1 year, 3 years, 5 years
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa College of Dentistry
name: Erica Teixeira, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: