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The Preventive Effect of 2-years Use of Hydroxyapatite Containing Toothpastes in Children.

Caries Clinical Trial

Official title:
The Caries Preventive Effect of 2-years Use of Hydroxyapatite Containing Toothpastes in Children. A Triple-blind Randomized Placebo-controlled Clinical Trial.

Clinical Trial Summary

The aim of this RCT was to verify the caries preventive efficacy of toothpastes containing biomimetic hydroxyapatite (H.A.) complex in children compared to traditional fluoridated toothpastes. In total 610 children of two age groups (4-5 years and 6-7 years at baseline) were enrolled. Four toothpastes, two containing fluoride-substituted hydroxyapatite (H.A.F.) (1000 and 1450 ppm F-) and magnesium-, strontium-, carbonate-substituted hydroxyapatite, in a chitosan matrix and two traditional fluoridated toothpastes (1000 and 1450 ppm F-) without other active components were administered randomly to two groups with younger children (Gyoung) and to two groups with older children those containing1450 ppm F (GOLD) during 24 months. A standardized questionnaire was administered to parents/caregivers to gain information regarding caries risk factors. Caries evaluation was performed at school using ICDAS, scoring lesions as initial (up to score 2), moderate (scores 3-4) and severe (scores 5-6).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04906291
Study type Interventional
Source Università degli Studi di Sassari
Contact
Status Completed
Phase N/A
Start date February 1, 2018
Completion date October 31, 2020
View Details
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