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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Clinical Trial to Evaluate a New Giomer Restorative System in Class V Restorations

Conditions
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Non-carious Cervical Lesions

Intervention / Treatment
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* Device: SHOFU Beautifil II LS
* Device: 3M/ESPE Filtek Supreme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHOFU Beautifil II LS<br>Composite: SHOFU Beautifil II LS, Bonding Agent: SHOFU BeautiBond | Device: SHOFU Beautifil II LS<br>* Placed under manufacturer's instructions<br>|
| Active Comparator: 3M/ESPE Filtek Supreme<br>Composite: 3M/ESPE Filtek Supreme, Bonding Agent: 3M/ESPE Scotchbond Universal | Device: 3M/ESPE Filtek Supreme<br>* Placed under manufacturer's instructions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hickel Criteria | Clinical assessments (Esthetic properties: surface luster, surface staining, marginal staining, color match, anatomical form, Functional properties: marginal adaptation, fracture of material and retention, radiographic examination, patient's view, and Biological Properties: postoperative hypersensitivity, recurrence of caries, tooth integrity and adjacent mucosa) will be performed by two trained examiners other than the operating clinician using modified Hickel criteria at baseline and follow-up visits. Differences between the two groups for Hickel criteria items will be examined with the Wilcoxon signed-rank test. | Up to 18 months |