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

NCT03153969 | Completed FDA Device

• 1 other identifier: 12486
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-carious Cervical Lesions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SHOFU Beautifil II LS

EXPERIMENTAL

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

Device: SHOFU Beautifil II LS

3M/ESPE Filtek Supreme

ACTIVE COMPARATOR

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

Device: 3M/ESPE Filtek Supreme

Interventions

SHOFU Beautifil II LS DEVICE

Placed under manufacturer's instructions

SHOFU Beautifil II LS

3M/ESPE Filtek Supreme DEVICE

Placed under manufacturer's instructions

3M/ESPE Filtek Supreme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• Shofu Inc.: collaborator

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Study Officials

• Gerard Kugel, DMD, MS, PhD

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 15, 2017
• Study Start: August 28, 2017
• Primary Completion: September 30, 2022
• Study Completion: November 15, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)