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

NCT04896294 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-10-01

No results posted yet for this study

Summary

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.

Conditions

  • Dentin Hypersensitivity

Interventions

COMBINATION_PRODUCT

Hygienic procedure (toothbrushing using HAP-containing toothpaste)

Toothbrushing using standardised technique and pear-sized amount of HAP-containing toothpaste twice daily for 1 month.

COMBINATION_PRODUCT

Hygienic procedure (toothbrushing using Zn Mg HAP-containing)

Toothbrushing using standardised technique and pear-sized amount of Zn Mg HAP-containing toothpaste twice daily for 1 month.

COMBINATION_PRODUCT

Hygienic procedure (toothbrushing using FAP-containing toothpaste)

Toothbrushing using standardised technique and pear-sized amount of FAP-containing toothpaste twice daily for 1 month.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Maria Polyakova, PhD · Sechenov University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-24
Primary Completion
2021-06-21
Completion
2021-07-19

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04896294 on ClinicalTrials.gov