NCT04590040

Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity

Randomized Non-inferiority Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Subjects will be enrolled into 3 balanced groups each using a different strength toothpaste. Dental hypersensitivity (DHS) will be assessed at study start, midway and study end.

Detailed description

This study is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group clinical trial. The three groups will be randomly assigned to use one of three test toothpastes having an identical base formulation but containing respectively either 0% nano-hydroxyapatite (HAP) (placebo), 15% nano-HAP or 5% KNO3 (positive control). All dental examinations for data collection will be conducted by the same Clinical Examiner.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
OTHER	Placebo	0% nano-HAP toothpaste
DEVICE	15% nano-HAP toothpaste	Toothpaste with identical base formulation as the placebo containing 15% nano-HAP
DEVICE	5% KNO3 toothpaste	Toothpaste with identical base formulation as the placebo containing 5% KNO3

Timeline

• Start date: 2020-07-28
• Primary completion: 2022-02-05
• Completion: 2023-03-01
• First posted: 2020-10-19
• Last updated: 2023-08-16
• Results posted: 2023-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study