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Completed

NCT Number: NCT03153969

Clinical Evaluation of 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.

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Key information

Conditions

Non-carious Cervical Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHOFU Beautifil II LS

Device

Placed under manufacturer's instructions

3M/ESPE Filtek Supreme

Device

Placed under manufacturer's instructions

Primary outcomes

  1. Hickel Criteria

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Shofu Inc.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 15, 2017
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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