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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04906291

Enrollment

610

Registered

2021-05-28

Start date

2018-02-01

Completion date

2020-10-31

Last updated

2021-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries

Keywords

Toothpaste, hydroxyapatite, Fluoride, Dental Caries, RCT, Children

Brief 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).

Interventions

OTHERToothpaste use

Brushing three times a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 8 Years

Healthy volunteers

Yes

Inclusion criteria

* Written declaration of informed consent signed by parents/guardians; * Age between 4-5 years and 6-7 years; Good general health, as assessed by the examiners; * Agreement of not to use any oral hygiene products except for the toothpastes provided for the duration of the study.

Exclusion criteria

* Ongoing oral or dental treatment except for emergency treatment; * Known allergic reaction to an oral hygiene product and/or medication and/or dental material previously used in the mouth or pharynx; * Allergy to one of the components of the test products or the standard toothpaste; * Participation in another clinical trial either currently or within the last 30 days; * Antibiotic therapy within the past 3 months.

Design outcomes

Primary

Measure	Time frame	Description
Caries Progression rate	2 year	. Caries incidence rate was calculated on each tooth (primary and permanent) as the unit of analysis

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026