Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079307
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-18
First Post:
2023-05-19
Brief Title:
Effect of Oxygenated Mouthwash and Mouth Foam
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Effect of Oxygenated Mouthwash and Mouth Foam on Oral Health and Quality of Life
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
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 Aim of this independent parallel twelve-week clinical study is to assess the efficacy of a commercially available oxygenated mouth rinse and mouth foam on both plaque level and gingival status in addition to assessing the oral health related quality of life
Detailed Description:
Participants in all groups will be examined for gingival inflammation and plaque accumulation The difference between three trial arms lies in the product used control oxygenated mouth wash oxygenated mouth foam A comparison against no intervention was disregarded due to ethical concerns children only examined without informing them about their oral problems After examination at baseline participants will be assigned to one arm of intervention All participants will be provided an oral health education and gingival scaling to remove any underlining predisposing factor for gingival inflammation as well as fluoridated toothpaste and a toothbrush Participants within intervention arms will also be provided the product package and informed how to use it oxygenated mouth wash oxygenated mouth foam
All three arms will be followed after 1week 2 weeks 4 weeks 8 weeks and 12 weeks from baseline examination
1 Control group Wont receive an oxygenated mouthwash nor oxygenated mouth foam 20 participants 2 Intervention Group A 20 participants - 2 oxygenated mouthwash bottle per individual for 3 months 40 bottles in total
3 Intervention Group B Oxygenated mouth foam day 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months 40 bottles in total
All three arms will be followed after 1week 2 weeks 4 weeks 8 weeks and 12 weeks from baseline examination
1 Control group Wont receive an oxygenated mouthwash nor oxygenated mouth foam 20 participants 2 Intervention Group A 20 participants - 2 oxygenated mouthwash bottle per individual for 3 months 40 bottles in total
3 Intervention Group B Oxygenated mouth foam day 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months 40 bottles in total
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None