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NCT Number: NCT06627790

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Pune, Maharashtra, 411018, India

Location status: Recruiting

Location contact

Dharmarajan Gopalakrishnan, Ph.D

CONTACT

[email protected]

9822046667

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 various stimuli.
  • Participants with minimum 20 natural teeth

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 the start 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, eating disorders, uncontrolled gastro-oesophageal reflux disease, excessive exposure to acids or any other systemic condition that predisposes to dentinal hypersensitivity
  • Severe Periodontal disease characterized by extensive tooth mobility and or extensive alveolar bone loss involving 10 or more teeth
  • Women who are pregnant or lactating

Treatment and study plan

Mouthwash preparation

Drug

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

Primary outcomes

  1. Dentinal Hypersensitivity

    Time frame: at 4, 8 and 12 week interval

    The dentinal hypersensitivity will be assessed using Visual Analogue Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Dharamrajan Gopalakrishnan, MDS, PhD

CONTACT

[email protected]

02027805600 ext. 00

Sponsors and collaborators

Lead sponsor

Dr. D. Y. Patil Dental College & Hospital

Other

Collaborators

  • Jasberry Healthcare Pvt. Ltd

Registry information

Official study title

Comparative Evaluation of Efficacy of a Potassium Nitrate Containing Herbal Mouthwash to a Potassium Oxalate Mouthwash in Dentinal Hypersensitivity - a Randomised Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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