Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627790
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Efficacy of a Potassium Nitrate Containing Herbal Mouthwash to a Potassium Oxalate Mouthwash in Dentinal Hypersensitivity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Evaluation of Efficacy of a Potassium Nitrate Containing Herbal Mouthwash to a Potassium Oxalate Mouthwash in Dentinal Hypersensitivity - a Randomised Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the efficacy of potassium nitrate containing herbal mouthwash to potassium oxalate mouthwash in management of dentinal hypersensitivity
Participants will be divided into two groups by computer generated randomization The participants will be divided into two groups Group A and Group B by Simple Random Allocation as both groups each group will involve 20 participants with at least two sites showing dentinal hypersensitivity
The assessment of Dentinal Hypersensitivity will be done after scaling andor root planing if required by subjecting affected sites with Air Blast Test ABT Cold Water Test CWT and Tactile Response assessment will be recorded using Visual Analogue Scale VAS All sensitivity tests will be executed by a single examiner who will be blinded to the randomization and will record DH at baseline and at 4 8 and 12 weeks
Participants will be divided into two groups by computer generated randomization The participants will be divided into two groups Group A and Group B by Simple Random Allocation as both groups each group will involve 20 participants with at least two sites showing dentinal hypersensitivity
The assessment of Dentinal Hypersensitivity will be done after scaling andor root planing if required by subjecting affected sites with Air Blast Test ABT Cold Water Test CWT and Tactile Response assessment will be recorded using Visual Analogue Scale VAS All sensitivity tests will be executed by a single examiner who will be blinded to the randomization and will record DH at baseline and at 4 8 and 12 weeks
Detailed Description:
Mouthwash has become accepted as a preferable delivery vehicle compared to pastes and gels due to ease of their use and access to all the areas of the mouth and ability to circumvent the discomfort that could occur when brushing the sensitive dentin surface because the osmolarity of toothpaste may increase pain sensations
This clinical trial is designed to assess the clinical efficacy of a Potassium nitrate containing Herbal mouthwash Jasmate Klinika Mouthwash compared with Potassium oxalate containing mouthwash Listerine Advance Defense Sensitive Mouthwash The Jasmate Klinika Mouthwash contains Curcumin and Potassium Nitrate as active ingredients The concentration of Potassium Nitrate KN is 5 and Curcumin is 2 The Listerine Advance Defense Sensitive Mouthwash contains Potassium Oxalate KO in 14 concentration
The participants will be divided into two groups Group A and Group B by Simple Random Allocation as both groups each group will involve 20 participants with at least two sites showing dentinal hypersensitivity
The assessment of Dentinal Hypersensitivity will be done after scaling andor root planing if required by subjecting affected sites with Air Blast Test ABT Cold Water Test CWT and Tactile Response assessment will be recorded using Visual Analogue Scale VAS All sensitivity tests will be executed by a single examiner who will be blinded to the randomization and will record DH at baseline and at 4 8 and 12 weeks
After the baseline assessment participants will be instructed for oral hygiene maintenance and the use of 10ml of mouthwash for rinsing twice daily for 60 seconds 30 minutes after brushing the teeth with standard toothpaste and soft bristled toothbrush
Participants will be asked to discontinue the use of mouthwash after 8 weeks and will be assessed at 12 weeks with Air Blast TestABT Cold Water TestCWT and Tactile Response assessment will be done using Visual Analogue ScaleVAS
This clinical trial is designed to assess the clinical efficacy of a Potassium nitrate containing Herbal mouthwash Jasmate Klinika Mouthwash compared with Potassium oxalate containing mouthwash Listerine Advance Defense Sensitive Mouthwash The Jasmate Klinika Mouthwash contains Curcumin and Potassium Nitrate as active ingredients The concentration of Potassium Nitrate KN is 5 and Curcumin is 2 The Listerine Advance Defense Sensitive Mouthwash contains Potassium Oxalate KO in 14 concentration
The participants will be divided into two groups Group A and Group B by Simple Random Allocation as both groups each group will involve 20 participants with at least two sites showing dentinal hypersensitivity
The assessment of Dentinal Hypersensitivity will be done after scaling andor root planing if required by subjecting affected sites with Air Blast Test ABT Cold Water Test CWT and Tactile Response assessment will be recorded using Visual Analogue Scale VAS All sensitivity tests will be executed by a single examiner who will be blinded to the randomization and will record DH at baseline and at 4 8 and 12 weeks
After the baseline assessment participants will be instructed for oral hygiene maintenance and the use of 10ml of mouthwash for rinsing twice daily for 60 seconds 30 minutes after brushing the teeth with standard toothpaste and soft bristled toothbrush
Participants will be asked to discontinue the use of mouthwash after 8 weeks and will be assessed at 12 weeks with Air Blast TestABT Cold Water TestCWT and Tactile Response assessment will be done using Visual Analogue ScaleVAS
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