Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT06082869
Status:
COMPLETED
Last Update Posted:
2023-10-13
First Post:
2023-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal
Sponsor:
Protegera, Inc.
Organization:
Study Overview
Official Title:
Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal
Status:
COMPLETED
Status Verified Date:
2023-10
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:
To evaluate and compare plaque removal efficacy and safety of a novel dentifrice formulation immediately after the first supervised use and following one week of twice, daily use at home.
Detailed Description:
Study participants brushed their teeth for one minute, two times daily, for seven days.
Participants who met study entry criteria were randomized to either the test (Protegera™) or control (Crest™ Cavity Protection) toothpaste, and each were given the same straight, soft bristled toothbrush to use throughout the study.
On Day 1, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded.
On Day 7, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded.
Participants who met study entry criteria were randomized to either the test (Protegera™) or control (Crest™ Cavity Protection) toothpaste, and each were given the same straight, soft bristled toothbrush to use throughout the study.
On Day 1, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded.
On Day 7, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: