NCT06166745

Efficacy of Sensi-IP Toothpaste in the Treatment of Dentinal Hypersensitivity Compared to a Sodium Fluoride Toothpaste

A Prospective, Randomized, Clinical Trial Comparing the Efficacy of Sensi-IP Toothpaste With a Sodium Fluoride Toothpaste in the Treatment of Dentinal Hypersensitivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: IR Scientific Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The study is designed as a prospective, randomized, parallel arm, double blinded, pilot clinical trial.The primary objective is to evaluate the efficacy of Sensi-IP +NaF as compared to a NaF toothpaste in the reduction of dentin hypersensitivity in adult participants over 14 days. Study endpoints include Evaporative Air blast Stimuli (Schiff Airblast Sensitivity Score), Tactile Stimuli (Yeaple probe Assessment), Visual Analogue Scale Evaporative Stimuli and the occurrence of adverse events. The study will include 2 study arms: 1. Sodium fluoride toothpaste with Sensi IP (N=23) and 2. Sodium fluoride toothpaste (N=23). Total of 46 participants (ages 18-80 years) with at least one hypersensitive tooth in 2 different quadrants which are anterior to the molars will be enrolled.

Detailed description

The Study design is a prospective, randomized, parallel arm, double blinded, single study site, proof of concept clinical trial. The study will include 2 study arms: 1) Brushing with sodium fluoride toothpaste with Sensi IP (N=23) and 2) Brushing with sodium fluoride toothpaste (N=23). A total of 46 adults (18 - 80 years of age) will be included in this clinical trial. To account for the potential of a 15% drop out, as many as 46 participants may be enrolled and treated with the goal of 20 participants per arm. Study procedures will take place at the following timelines shown below: Visit 1: Screening Visit -Informed consent; Screening for eligibility Visit 2: Baseline Day 1: 7 days post screening; (+/- 1 Day) -Confirm eligibility, 1st treatment with allocated product Visit 3 Day 2: 1 Day after Visit 2; (+1 Day) -Study Assessments Visit 4: Day 14 (14 days after Visit 2 ;+/ 2 Days) -Final Study Assessments and Study Exit

Conditions

• Dentinal Hypersensitivity

Interventions

Type	Name	Description
DEVICE	Sensi-IP toothpaste	Brushing daily with the Sensi-IP toothpaste for 14 days for dentinal hypersensitivity.
DEVICE	Sodium Fluoride Toothpaste	Brushing daily with the Sodium Fluoride toothpaste for 14 days for dentinal hypersensitivity.

Timeline

• Start date: 2023-11-06
• Primary completion: 2023-12-23
• Completion: 2024-04-15
• First posted: 2023-12-12
• Last updated: 2024-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study