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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-carious Cervical Lesions
• Intervention / Treatment: Device: SHOFU Beautifil II LS; Device: 3M/ESPE Filtek Supreme

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Shofu Inc.
• Investigators: Principal Investigator: Gerard Kugel, DMD, MS, PhD, Tufts University School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 12486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No