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RecruitingNCT06627790Updated Feb 13, 2025

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

A Phase 3 interventional study of Mouthwash preparation in Dentin Hypersensitivity, sponsored by Dr. D. Y. Patil Dental College & Hospital. Recruiting at 1 site in India. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Dr. D. Y. Patil Dental College & Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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
Read the 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)
02

Conditions studied

  • Dentin Hypersensitivity

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Keywords

  • dentinal hypersensitivity
03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Dr. D. Y. Patil Dental College & Hospital is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to various stimuli.
  • Participants with minimum 20 natural teeth

Exclusion criteria

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Potassium nitrate containing herbal mouthwash

    Group A: Participants will be adviced to use mouthwash twice daily in 10ml volume for 60 seconds, 30 minutes after brushing and not to eat anything for 45 minutes

    Drug: Mouthwash preparation

  • Active comparator
    Potassium oxalate mouthwash

    Group B: Participants will be adviced to use mouthwash twice daily in 10ml volume for 60 seconds, 30 minutes after brushing and not to eat anything for 45 minutes.

    Drug: Mouthwash preparation

Interventions

  • DrugMouthwash 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

06

What researchers measure

Primary outcomes

  1. Dentinal Hypersensitivity

    The dentinal hypersensitivity will be assessed using Visual Analogue Scale

    Time frame: at 4, 8 and 12 week interval

07

Study locations

1 of 1 sites recruiting
  • Dr. D Y Patil dental College and Hospital, Pimpri, Pune
    Pune, Maharashtra 411018, India
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06627790
Lead sponsor
Dr. D. Y. Patil Dental College & Hospital
Collaborators
Jasberry Healthcare Pvt. Ltd
Responsible party
D. Gopalakrishnan (DEAN PROFESSOR AND HOD, Dr. D. Y. Patil Dental College & Hospital) — Principal investigator
First posted
Oct 4, 2024
Start date
Feb 25, 2025 (estimated)
Primary completion
May 2025 (estimated)
Completion
May 2025 (estimated)
Last update
Feb 13, 2025

Study contacts

Dharamrajan Gopalakrishnan, MDS, PhD
Contact
drgopal@dpu.edu.in
02027805600 ext. 00

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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