Actively Recruiting

Phase 3
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID06627790

Comparative Evaluation of Potassium Nitrate Herbal Mouthwash Versus Potassium Oxalate Mouthwash in Dentinal Hypersensitivity - Randomized Clinical Trial

Led by Dr. D. Y. Patil Dental College & Hospital · Updated on 2025-02-13

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Dr. D. Y. Patil Dental College & Hospital

Lead Sponsor

J

Jasberry Healthcare Pvt. Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a potassium nitrate containing herbal mouthwash compared to a potassium oxalate mouthwash for managing dentinal hypersensitivity. This randomized clinical trial aims to find which mouthwash better reduces sensitivity at affected tooth sites. The study involves adults aged 18 to 60 years with at least two sensitive teeth sites, assessing pain responses using various tests and a visual scale over 12 weeks. Participants will be randomly assigned to one of two groups: one using the herbal mouthwash containing 5% potassium nitrate and 2% curcumin, and the other using a potassium oxalate mouthwash with 1.4% concentration. Both groups will receive scaling and root planing if needed, then use 10 ml of their assigned mouthwash twice daily for 60 seconds, 30 minutes after brushing, over an 8-week period. After stopping mouthwash use at 8 weeks, participants will be followed until 12 weeks for final sensitivity assessment. Throughout the study, dentinal hypersensitivity will be measured at baseline, 4, 8, and 12 weeks using air blast, cold water, and tactile response tests scored on a visual analogue scale. Tests will be conducted by a blinded examiner. Participants will maintain oral hygiene and avoid eating for 45 minutes after rinsing. The trial will monitor changes in sensitivity over time to evaluate which mouthwash best reduces symptoms.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with at least two dentinal hypersensitivity sites scoring 4 or higher on the visual analogue scale
  • Teeth showing cervical abrasion, erosion, or gingival recession
  • Adults older than 18 years in generally good health
  • Participants reporting a history of dentinal hypersensitivity to various stimuli
  • Participants with at least 20 natural teeth
Not Eligible

You will not qualify if you...

  • Teeth with severe caries, faulty restoration, prosthetic crown, chipping, fracture, or pulpal damage symptoms
  • Participants who took long-term analgesic therapy within 30 days before the study
  • Participants treated for dentinal hypersensitivity in the past 3 months
  • Participants undergoing orthodontic therapy
  • Participants with kidney disorders, kidney stones, eating disorders, uncontrolled gastro-oesophageal reflux disease, or other systemic conditions causing dentinal hypersensitivity
  • Severe periodontal disease with extensive tooth mobility or bone loss involving 10 or more teeth
  • Women who are pregnant or breastfeeding

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants use mouthwash twice daily in 10ml volume for 60 seconds, 30 minutes after brushing their teeth, for 8 weeks. They are instructed to maintain oral hygiene and avoid eating for 45 minutes after rinsing.

Visits at baseline, Week 4, and Week 8 for sensitivity assessments

Follow-up

Duration - 4 weeks

Participants discontinue mouthwash use and are assessed for dentinal hypersensitivity at Week 12.

1 visit (in-person) at Week 12

Trial Site Locations

Total: 1 location

1

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

Pune, Maharashtra, India, 411018

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Research Team

D

Dharamrajan Gopalakrishnan, MDS, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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