NCT04906291

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

Completed NA Last updated 28 May 2021

What this trial tests

NA trial testing Toothpaste use in Caries in 610 participants. Completed in 31 October 2020.

Timeline

1 February 2018

Primary endpoint
30 June 2020

31 October 2020

Quick facts

Lead sponsor	Università degli Studi di Sassari
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	610
Start date	1 February 2018
Primary completion	30 June 2020
Estimated completion	31 October 2020
Sites	1 location across Italy

Drugs / interventions tested

• Toothpaste use

Conditions studied

• Caries — all drugs for Caries →

Sponsor

Università degli Studi di Sassari

Who can join

Adults 4 to 8, any sex, with Caries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies.
   Domingues C, Jarak I, Veiga F, Dourado M, et al · · 2023 · cited 33× · PMID 37896191 · DOI 10.3390/pharmaceutics15102431
2. Hydroxyapatite-Fluoride Toothpastes on Caries Activity: A Triple-Blind Randomized Clinical Trial.
   Cocco F, Salerno C, Wierichs RJ, Wolf TG, et al · · 2025 · cited 4× · PMID 39971658 · DOI 10.1016/j.identj.2024.09.037
3. Effects of Hydroxyapatite-Containing Toothpastes on Some Caries-Related Variables: A Randomised Clinical Trial.
   Campus G, Cocco F, Wierichs RJ, Wolf TG, et al · · 2024 · cited 4× · PMID 38453554 · DOI 10.1016/j.identj.2024.01.028