NCT05623761

Toothpastes With Thermal Water for Oral Health

The Effect of Toothpastes Based on Alkaline Thermal Water With and Without Fluorinated Derivative on Gingivitis, Dentin Hypersensitivity, and Oral Hygiene: a Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare the effect of toothpastes containing thermal water of Castera-Verduzan with 1450 ppm fluoride and without fluorinated derivatives on oral hygiene, gingivitis, and dentin hypersensitivity in young adults.

Detailed description

This will be a double-blind, randomized, two-arm parallel-group study of the effect of toothpastes containing thermal water of Castera-Verduzan with 1450 ppm fluoride and without fluorinated derivatives. The groups will include adults with gingivitis and dentinal hypersensitivity (DH) diagnosed clinically. To assess the effect of the toothpastes, the following parameters will be used: gingival health (modified gingival index, MGI; gingival bleeding index, BI), dentin sensitivity (Shiff's index, VAS), oral hygiene level (Navi-Rustogi index), and salivary pH.

Conditions

• Gingivitis
• Dentin Hypersensitivity

Interventions

Type	Name	Description
DRUG	BUCCOTHERM® Sensitive Gums with Fluoride	Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums with Fluoride twice daily for 1 month.
DRUG	BUCCOTHERM® Sensitive Gums Fluoride-Free	Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums Fluoride-Free twice daily for 1 month.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-01-30
• Completion: 2023-02-15
• First posted: 2022-11-21
• Last updated: 2023-03-01

Locations

1 site across 1 country: Russia