NCT06627790

Efficacy of a Potassium Nitrate Containing Herbal Mouthwash to a Potassium Oxalate Mouthwash in Dentinal Hypersensitivity

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Dr. D. Y. Patil Dental College & Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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 and/or 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 1.4% 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 and/or 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 Test(ABT), Cold Water Test(CWT) and Tactile Response assessment will be done using Visual Analogue Scale(VAS)

Conditions

• Dentin Hypersensitivity

Interventions

Type	Name	Description
DRUG	Mouthwash preparation	Participants will be divided into two groups Group A and Group B Both the groups will receive thorough scaling and root planing at required sites. Use of mouthwash preparation is adviced for 8 weeks and discontinue after for 4 weeks. The Visual analogue scale Hypersensitivity will be assessed via Visual Analogue Scale at 4, 8 and 12 week interval

Timeline

• Start date: 2025-02-25
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-10-04
• Last updated: 2025-02-13

Locations

1 site across 1 country: India