Clinical Evaluation of a New Giomer Restorative System in Class V Restorations

Tufts University

Status

Completed

Conditions

Non-carious Cervical Lesions

Treatments

Device: SHOFU Beautifil II LS

Device: 3M/ESPE Filtek Supreme

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03153969

12486

Details and patient eligibility

About

The objective of this study is to evaluate the clinical effectiveness of a new composite resin (SHOFU Beautifil II LS) vs a control (3M/ESPE Filtek Supreme) for use in restoring non carious cervical lesions Class V lesions.

3M ESPE FiltekTM Supreme is one of the composite resin materials that will be used in this study (Group 1). This is a light-activated, flowable restorative composite.

Shofu Beautifil II LS (SI R21204) is a new type of filling material called a Giomer. This is the second composite that will be used in this study (Group 2) Giomer is a collective term for dental materials that will release ions, such as fluoride. Results from previous studies show that the released ions may have beneficial effects on the tooth, including strengthening the tooth.

In each participant, one tooth with a class V lesion will be randomized to group 1, and a second tooth with a class V lesion will be randomized to group 2. The restorations will be observed over 18 months to determine clinical acceptability.

Full description

This is a single-center, non-blinded, controlled, split mouth, clinical trial 18 months in duration.

The purpose of this clinical trial is to evaluate the effectiveness of a new Giomer restorative system (Shofu Beautifil LS) for use in restoring non carious Class V lesions by comparing it to 3M ESPE FiltekTM Supreme in the following categories:

Clinical Assessments (Documentation at baseline, 6months and 18months):

Surface Luster
Surface Staining
Marginal Staining
Color Match
Anatomical Form
Marginal Adaptation
Fracture of Material and Retention
Radiographic Examination
Patient's View
Postoperative Hypersensitivity
Recurrence of Caries
Tooth Integrity
Adjacent Mucosa

Sensitivity interview- assessed preoperatively (prior to anesthesia, if needed) at baseline and after restoration placement

Dentin Sclerosis Rating- assessed at baseline

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18 years or older, in general health
Must have a minimum of 2 cervical lesions in need of restoration
Cervical lesions must provide for a minimum of 1mm thickness of restorative material while maintaining natural tooth contour
At least 50% of lesion must be in dentin
Coronal margin of lesion must be in enamel

Exclusion criteria

Rampant uncontrolled caries
Systemic or local disorders that contra-indicate the dental procedures included in this study
Evidence of xerostomia
Evidence of severe bruxing or clenching or in need of TMJ related therapy
Women who are pregnant or breast feeding (self-reported).
Known allergy to resin composites or local anesthetics
Abnormal oral soft tissue findings (e.g., open sores, lesions)
Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome)
Teeth with periapical pathology or exhibiting symptoms of pulpal pathology
Teeth that are non-vital or have had root canal therapy
Teeth that have been pulp capped
Teeth with near exposures on pre-operative radiographs
Hypersensitive teeth
Teeth with a periodontal pocket of more than 4mm with bleeding on probing
Teeth that are used as abutments for removable partial dentures