NCT04896294

Ca-hydroxyapatite, Fluoroapatite, and Mg-Zn-hydroxyapatite for Dentin Hypersensitivity Management

Completed Phase 4 Last updated 1 October 2021

What this trial tests

Phase 4 trial testing Hygienic procedure (toothbrushing using HAP-containing toothpaste) in Dentin Hypersensitivity in 30 participants. Completed in 19 July 2021.

Timeline

24 April 2021

Primary endpoint
21 June 2021

19 July 2021

Quick facts

Lead sponsor	I.M. Sechenov First Moscow State Medical University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	24 April 2021
Primary completion	21 June 2021
Estimated completion	19 July 2021
Sites	1 location across Russia

Drugs / interventions tested

• Hygienic procedure (toothbrushing using HAP-containing toothpaste)
• Hygienic procedure (toothbrushing using Zn Mg HAP-containing)
• Hygienic procedure (toothbrushing using FAP-containing toothpaste)

Conditions studied

• Dentin Hypersensitivity — all drugs for Dentin Hypersensitivity →

Sponsor

I.M. Sechenov First Moscow State Medical University

Who can join

Adults 35 to 45, any sex, with Dentin Hypersensitivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This will be a double-blind, randomized, three-arm parallel groups study of the effect of toothpastes containing Ca-hydroxyapatite (HAP), Mg-Zn-hydroxyapatite (Zn-Mg-HAP), or fluoroapatite (FAP).

The aim of the study is to compare the effect of toothpastes containing Ca-hydroxyapatite (HAP), fluoroapatite (FAP), and Mg-Zn-hydroxyapatite (Mg-Zn-HAP) on dentin hypersensitivity associated with dental abrasion.

Materials and methods. Thirty consent patients aged 35-45 with dentin hypersensitivity associated with abrasion will be recruited for the study. The study will have 2 phases: preparatory phase (recruitment of the patients, standardization of their oral hygiene protocols, wash-out period, calibration of the researchers and training) and the main part (double-blind, randomized, parallel groups study of toothpastes effect). Patients will be randomly divided into 3 groups (group 1 - toothpastes with Ca-HAP, group 2 - toothpastes with Zn-Mg-HAP, group 3 - toothpastes with FAP). Clinical examination will be performed at the baseline, after 2 and 4 weeks, and will include patient's interview, oral hygiene level assessment (OHI-S), and dentin sensitivity testing (Shiff's index).

The null hypothesis is that there will be no statistically significant differences in dentin sensitivity level between the study groups.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Effect of Toothpastes Containing Hydroxyapatite, Fluoroapatite, and Zn-Mg-hydroxyapatite Nanocrystals on Dentin Hypersensitivity: A Randomized Clinical Trial.
   Polyakova M, Sokhova I, Doroshina V, Arakelyan M, et al · · 2022 · cited 13× · PMID 35462739 · DOI 10.4103/jispcd.jispcd_333_21