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

NCT ID: NCT03153969

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-28
• Study Completion Date: 2022-11-15

Brief Summary

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

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

Conditions

Non-carious Cervical Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SHOFU Beautifil II LS

Composite: SHOFU Beautifil II LS, Bonding Agent: SHOFU BeautiBond

Group Type: EXPERIMENTAL

SHOFU Beautifil II LS

Intervention Type: DEVICE

Placed under manufacturer's instructions

3M/ESPE Filtek Supreme

Composite: 3M/ESPE Filtek Supreme, Bonding Agent: 3M/ESPE Scotchbond Universal

Group Type: ACTIVE_COMPARATOR

3M/ESPE Filtek Supreme

Intervention Type: DEVICE

Placed under manufacturer's instructions

Interventions

SHOFU Beautifil II LS

Placed under manufacturer's instructions

Intervention Type: DEVICE

3M/ESPE Filtek Supreme

Placed under manufacturer's instructions

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shofu Inc.

INDUSTRY

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Gerard Kugel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerard Kugel, DMD, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Dental Medicine

Locations

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

12486

Identifier Type: -

Identifier Source: org_study_id