Comparing two mouthwashes for treating 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
PHASE3 · Dr. D. Y. Patil Dental College & Hospital · NCT06627790
This study is testing which mouthwash works better to relieve tooth sensitivity in people who have it.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Dr. D. Y. Patil Dental College & Hospital (other) |
| Locations | 1 site (Pune, Maharashtra) |
| Trial ID | NCT06627790 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a potassium nitrate containing herbal mouthwash against a potassium oxalate mouthwash in managing dentinal hypersensitivity. Participants will be randomly assigned to one of two groups, each receiving a different mouthwash, and their sensitivity will be assessed using various tests over a 12-week period. The study focuses on individuals with at least two sites of dentinal hypersensitivity, ensuring a controlled and blinded assessment of outcomes. The trial seeks to determine which mouthwash provides better relief from sensitivity symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with at least two sites of dentinal hypersensitivity and a VAS score of 4 or higher.
Not a fit: Patients with severe dental issues, ongoing orthodontic therapy, or systemic conditions affecting dentinal hypersensitivity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective treatment option for dentinal hypersensitivity.
How similar studies have performed: Previous studies have shown varying degrees of success with similar mouthwash formulations, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pune, Maharashtra
- Dr. D Y Patil dental College and Hospital, Pimpri, Pune — Pune, Maharashtra, India (RECRUITING)
Study contacts
- Study coordinator: Dharamrajan Gopalakrishnan, MDS, PhD
- Email: drgopal@dpu.edu.in
- Phone: 02027805600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dentin Hypersensitivity, dentinal hypersensitivity