Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT01496456
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2011-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Radiographic Progression of Infiltrated Caries Lesions In-vivo
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Radiographic Progression of Infiltrated Caries Lesions In-vivo
Status:
COMPLETED
Status Verified Date:
2017-07
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:
ICON
Brief Summary:
This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.
Detailed Description:
A 3-year longitudinal, prospective, randomized control clinical trial (RCT) is designed incorporating a split-mouth intra-oral design. Young volunteers (14-35 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by infiltrating the lesions. The infiltration protocol included application of on-market materials and applicators, and was performed in one session.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10-PAF03721 | OTHER | U-Michigan | View |