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

Last updated: February 11, 2025
Sponsor: Dr. D. Y. Patil Dental College & Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Allergy

Allergies & Asthma

Allergy (Pediatric)

Treatment

Mouthwash preparation

Clinical Study ID

NCT06627790
DYPDCH/DPU/EC/582/130/2023
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with at least two DH sites with VAS score ≥4

  • Participants with teeth showing cervical abrasion, erosion, gingival recession

  • Participants >18 years in general good health

  • Participants self-reporting with history of dentinal hypersensitivity to variousstimuli.

  • Participants with minimum 20 natural teeth

Exclusion

Exclusion Criteria:

  • Teeth with severe caries, faulty restoration, prosthetic crown, chipping, fracture,symptoms of pulpal damage

  • Participants who has taken long term analgesic therapy within 30 days before thestart of the study

  • Participants who have undergone any treatment for dentinal hypersensitivity in past 3 months

  • Participants with ongoing orthodontic therapy

  • Participants with history or presence kidney disorder, kidney stones, eatingdisorders, uncontrolled gastro-oesophageal reflux disease, excessive exposure toacids or any other systemic condition that predisposes to dentinal hypersensitivity

  • Severe Periodontal disease characterized by extensive tooth mobility and orextensive alveolar bone loss involving 10 or more teeth

  • Women who are pregnant or lactating

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Mouthwash preparation
Phase: 3
Study Start date:
February 25, 2025
Estimated Completion Date:
May 31, 2025

Study 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)

Connect with a study center

  • Dr. D Y Patil dental College and Hospital, Pimpri, Pune

    Pune, Maharashtra 411018
    India

    Active - Recruiting

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