NCT06627790

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

October 3, 2024

Last Update Submit

February 11, 2025

Conditions

Dentin Hypersensitivity

Keywords

dentinal hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • Dentinal Hypersensitivity

    The dentinal hypersensitivity will be assessed using Visual Analogue Scale

    at 4, 8 and 12 week interval

Study Arms (2)

Potassium nitrate containing herbal mouthwash

EXPERIMENTAL

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

Potassium oxalate mouthwash

ACTIVE COMPARATOR

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

Mouthwash preparationDRUG

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

Potassium nitrate containing herbal mouthwashPotassium oxalate mouthwash

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pune, Maharashtra, 411018, India

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Central Study Contacts

Dharamrajan Gopalakrishnan, MDS, PhD

CONTACT

02027805600drgopal@dpu.edu.in

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DEAN PROFESSOR AND HOD

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 4, 2024

Study Start

February 25, 2025

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)