NCT06627790 Efficacy of a Potassium Nitrate Containing Herbal Mouthwash to a Potassium Oxalate Mouthwash in Dentinal Hypersensitivity
| NCT ID | NCT06627790 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Dr. D. Y. Patil Dental College & Hospital |
| Condition | Dentin Hypersensitivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2025-02-25 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06627790 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Dentin Hypersensitivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06627790 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT06627790 currently recruiting?
Yes, NCT06627790 is actively recruiting participants. Contact the research team at drgopal@dpu.edu.in for enrollment information.
Where is the NCT06627790 trial being conducted?
This trial is being conducted at Pune, India.
Who is sponsoring the NCT06627790 clinical trial?
NCT06627790 is sponsored by Dr. D. Y. Patil Dental College & Hospital. The trial plans to enroll 40 participants.