Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03160560
Status:
COMPLETED
Last Update Posted:
2021-01-07
First Post:
2017-05-10
Brief Title:
Controlling Oral Malodor by ClōSYS Oral Rinse
Sponsor:
Rowpar Pharmaceuticals Inc
Organization:
Rowpar Pharmaceuticals Inc
Study Overview
Official Title:
Efficacy of ClōSYS Oral Rinse Products in Human Subjects in Controlling Oral Malodor
Status:
COMPLETED
Status Verified Date:
2020-12
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 assess the efficacy of two ClōSYS Oral Rinse products in human subjects in controlling oral malodor in partial fulfillment of the requirements for American Dental Associations ADA requirement for obtaining ADA Seal for malodor
Detailed Description:
Study Design
The products used in the study are ClōSYS Alcohol-Free Oral Rinse also referred as ClōSYS Unflavored Oral Rinse and ClōSYS justRIGHT MILD MINT Oral Rinse also referred as ClōSYS Flavored Oral Rinse or Gentle Mint Flavored Oral Rinse This is an in-vivo eight-week a single-center randomized double-blind subjectinvestigator 2-way cross-over design clinical study There are two independent groups Each subject of each group gets crossed over to the other sub-group within a same group after the washout period Each group has their own control group In the first phase 25 subjects 50 of each group are randomly assigned to the active group the other 25 subjects are assigned to the control group In the second phase the participants will be crossed over within sub-group assignment The Study enrolled 100 subjects aged 21 to 65 years with a slight to strong intrinsic oral malodor as determined by a panel of trained odor judges calibrated and standardized using a range of standard odorants sufficient to reflect the different patterns of nose receptors
Study Plan
Subjects will receive verbal and written oral hygiene instructions and either one bottle 16 oz each of ClōSYS Unflavored Oral Rinse ClōSYS Flavored Oral Rinse- or Placebo Oral Rinse each week Subjects will also receive measuring cups for dispensing the rinse and a diary log for recording usage the Oral Hygiene Kit for use during the treatment After a 2-week wash out period each subject will receive another bottle of oral rinse according to their group assignment
Subjects will be instructed to rinse twice a day each in the morning and in the evening with 15 mL mouth rinse for 30 seconds They will note in their patients log the date and time of rinsing
Subjects will be instructed to continue with their normal oral hygiene practices including tooth brushing but omitting any use of oral rinses or mouthwashes except for the Study materials The subjects also will be instructed not to use other non-study related products such as breath mints lozenge gums etc as well as refraining from elective dental procedures during the study period
The products used in the study are ClōSYS Alcohol-Free Oral Rinse also referred as ClōSYS Unflavored Oral Rinse and ClōSYS justRIGHT MILD MINT Oral Rinse also referred as ClōSYS Flavored Oral Rinse or Gentle Mint Flavored Oral Rinse This is an in-vivo eight-week a single-center randomized double-blind subjectinvestigator 2-way cross-over design clinical study There are two independent groups Each subject of each group gets crossed over to the other sub-group within a same group after the washout period Each group has their own control group In the first phase 25 subjects 50 of each group are randomly assigned to the active group the other 25 subjects are assigned to the control group In the second phase the participants will be crossed over within sub-group assignment The Study enrolled 100 subjects aged 21 to 65 years with a slight to strong intrinsic oral malodor as determined by a panel of trained odor judges calibrated and standardized using a range of standard odorants sufficient to reflect the different patterns of nose receptors
Study Plan
Subjects will receive verbal and written oral hygiene instructions and either one bottle 16 oz each of ClōSYS Unflavored Oral Rinse ClōSYS Flavored Oral Rinse- or Placebo Oral Rinse each week Subjects will also receive measuring cups for dispensing the rinse and a diary log for recording usage the Oral Hygiene Kit for use during the treatment After a 2-week wash out period each subject will receive another bottle of oral rinse according to their group assignment
Subjects will be instructed to rinse twice a day each in the morning and in the evening with 15 mL mouth rinse for 30 seconds They will note in their patients log the date and time of rinsing
Subjects will be instructed to continue with their normal oral hygiene practices including tooth brushing but omitting any use of oral rinses or mouthwashes except for the Study materials The subjects also will be instructed not to use other non-study related products such as breath mints lozenge gums etc as well as refraining from elective dental procedures during the study period
Study Oversight
Has Oversight DMC:
None
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?:
None