Comparison of Efficacy of 5% Fluorocalcium Phosphosilicate Dentifrice and Potassium Nitrate Dentifrice on Dentinal Hypersensitivity

Comparison Of Efficacy Of Dentifrice Containing 5% Fluorocalcium Phosphosilicate With Dentifrice Containing Potassium Nitrate And Placebo On Dentinal Hypersensitivity: A Triple Masked Randomized Controlled Clinical Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03738514

Enrollment

120

Registered

2018-11-13

Start date

2017-12-22

Completion date

2018-02-22

Last updated

2018-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentinal Hypersensitivity

Keywords

Dentinal Hypersensitivity, Visual Analogue Score

Brief summary

Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro calcium phosphosilicate and dentifrice containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.

Detailed description

A total of 120 subjects were divided into 3 groups randomly. Group 1 was given the dentifrice containing 5% fluoro calcium phosphosilicate ,Group 2 was given the dentifrice containing potassium nitrate and group 3 was given placebo. Sensitivity scores (VAS score) were recorded at baseline, 2 weeks, 6 weeks.

Interventions

OTHER5% fluorocalcium phosphosilicate dentifrice

dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks

OTHER5% potassium nitrate dentifrice

5% potassium nitrate dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.

OTHERPlacebo dentrifice

placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* The volunteers selected at baseline were in good general health and should have at least 20 natural permanent teeth and history of hypersensitivity to hot, cold, sour stimuli on at least two teeth with a VAS score of ≥4.

Exclusion criteria

* Patients with active cervical caries or deep abrasion requiring cervical filling, chipped teeth or fractured cusps, tender tooth in same quadrant as the hypersensitive teeth, Subjects using any type of desensitizing paste or desensitizing therapy for last 6 months, Pregnant/ lactating women or subjects with history of chronic use of anti-inflammatory and analgesic medications were excluded.

Design outcomes

Primary

Measure	Time frame	Description
Visual Analogue Scale score for Dentinal Hypersensitivity	Change in VAS score from Baseline to 12 weeks	Based on a 10-cm VAS score which was used to measure tooth sensitivity, a pain-free response was allotted a score of zero whereas a score of 10 was given to subjects with excruciating pain or discomfort.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026