Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-09 @ 3:48 AM
Study NCT ID:
NCT03032705
Status:
COMPLETED
Last Update Posted:
2021-12-13
First Post:
2017-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
Sponsor:
Tufts University
Organization:
Study Overview
Official Title:
Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
Status:
COMPLETED
Status Verified Date:
2021-11
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 purpose of this study is to compare esthetic, functional and biological properties of two restoration materials used to fill cavities. One material is called "Filtek™ Supreme" which is a traditional tooth colored resin composite that is placed in the cavity in layers and hardened with UV light. The second material is called "SonicFill™ 2," which is a bulk fill composite that uses an ultrasonic hand piece to change the material from a solid into a liquid in order to place it into the cavity. This material can be placed in the cavity in 1 layer, and is hardened using UV light. Both materials have been FDA approved as non-significant risk devices for filling cavities.
In each subject, one tooth with a cavity will be randomly selected to receive one filling material, and a second tooth with a cavity will be randomly selected to receive the second material. The fillings will be observed over a two year period to determine clinical acceptability.
In each subject, one tooth with a cavity will be randomly selected to receive one filling material, and a second tooth with a cavity will be randomly selected to receive the second material. The fillings will be observed over a two year period to determine clinical acceptability.
Detailed Description:
This study is a randomized, split-mouth, controlled, examiner-blinded clinical evaluation of Class II restorations using a new bulk-fill composite (SonicFill™ 2) and comparing it to Filtek™ Supreme resin composite placed in the traditional incremental technique.
The primary objective of this study is to evaluate the clinical performance of a sonic-activated, bulk fill composite, SonicFill™ 2, by comparing it to Filtek™ Supreme in the following categories:
Esthetic Properties
* Surface luster
* Staining - surface
* Staining - margin
* Color match and translucency
* Esthetic anatomical form
Functional Properties
* Fracture of material and retention
* Marginal adaptation
* Approximate anatomical form - contact point
* Radio-graphic examination (when applicable)
* Patient's view
Biological Properties
* Postoperative (hyper-)sensitivity and tooth vitality
* Recurrence of caries, erosion, abfraction
* Tooth integrity (enamel cracks, tooth fractures)
* Adjacent mucosa
The hypothesis to be tested is that the sonic-activated, bulk fill composite, SonicFill™ 2, will have comparable results to the traditional incremental technique composite, Filtek™ Supreme, in overall clinical acceptability and in all compared categories
The primary objective of this study is to evaluate the clinical performance of a sonic-activated, bulk fill composite, SonicFill™ 2, by comparing it to Filtek™ Supreme in the following categories:
Esthetic Properties
* Surface luster
* Staining - surface
* Staining - margin
* Color match and translucency
* Esthetic anatomical form
Functional Properties
* Fracture of material and retention
* Marginal adaptation
* Approximate anatomical form - contact point
* Radio-graphic examination (when applicable)
* Patient's view
Biological Properties
* Postoperative (hyper-)sensitivity and tooth vitality
* Recurrence of caries, erosion, abfraction
* Tooth integrity (enamel cracks, tooth fractures)
* Adjacent mucosa
The hypothesis to be tested is that the sonic-activated, bulk fill composite, SonicFill™ 2, will have comparable results to the traditional incremental technique composite, Filtek™ Supreme, in overall clinical acceptability and in all compared categories
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?:
None
Is an FDA AA801 Violation?: