Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04899440
Status:
COMPLETED
Last Update Posted:
2022-08-01
First Post:
2021-05-19
Brief Title:
Measuring Efficacy of an Oral-Irrigator After Three Weeks of Use
Sponsor:
Procter and Gamble
Organization:
Procter and Gamble
Study Overview
Official Title:
An Experimental Clinical Study to Assess the Gingivitis and Plaque Reduction Efficacy of an Oral-Irrigator After Three Weeks of Use
Status:
COMPLETED
Status Verified Date:
2022-07
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:
None
Brief Summary:
The primary objective of this exploratory study is to evaluate the efficacy of an Oral Irrigator in the reduction of gingivitis compared to a negative control over a 3 week period by using the Modified Gingival Index and the Gingival Bleeding Index The secondary objective is to evaluate the efficacy of an Oral Irrigator in the reduction of plaque compared to a negative control using the extended Turesky Modified Quigley-Hein Index TQHPI after 3 weeks of use
Detailed Description:
This is a single-center examiner-blind three 3 week two 2 treatment parallel group randomized study design Thirty 30 subjects who have shown evidence of gingivitis and plaque will be enrolled in this study Subjects will be evaluated for gingivitis using the Modified Gingival Index MGI and the Gingival Bleeding Index GBI and evaluated for plaque using the Turesky Modified Quigley-Hein Plaque Index TQHPI at two 2 time points Baseline and after three 3 weeks of product use Qualified subjects will be stratified and randomly assigned to one of the two treatment groups toothbrushing on conjunction with an Oral Irrigator or toothbrushing without an Oral Irrigator N15treatment Subjects will be instructed to brush twice a day for approximately three 3 weeks with their assigned products and return for plaque and gingivitis measures at approximately three 3 weeks after the Baseline visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None