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

Not Applicable

Completed

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

• Registration Number: NCT03153969
• Lead Sponsor: Tufts University

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

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Study Start: 2017-08-28
• Primary Completion: 2022-09-30
• Status Verified: 2022-11
• Study Completion: 2022-11-15
• Last Update Submitted: 2022-11-15
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHOFU Beautifil II LS	SHOFU Beautifil II LS	Composite: SHOFU Beautifil II LS, Bonding Agent: SHOFU BeautiBond
3M/ESPE Filtek Supreme	3M/ESPE Filtek Supreme	Composite: 3M/ESPE Filtek Supreme, Bonding Agent: 3M/ESPE Scotchbond Universal

Primary Outcome Measures

Name	Time	Method
Hickel Criteria	Up to 18 months	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.

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States