Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-04-19 @ 5:56 AM
Study NCT ID:
NCT03153969
Status:
COMPLETED
Last Update Posted:
2022-11-16
First Post:
2017-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of a New Giomer Restorative System in Class V Restorations
Sponsor:
Tufts University
Organization:
Study Overview
Official Title:
A Clinical Trial to Evaluate a New Giomer Restorative System in Class V Restorations
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: