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

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).

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Key information

Conditions

Caries Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sassari, Dept of Surgery, Microsurtgery and Medicine Sciences

Sassari, SS, 07100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Toothpaste use

Other

Brushing three times a day

Primary outcomes

Caries Progression rate

Time frame: 2 year

. Caries incidence rate was calculated on each tooth (primary and permanent) as the unit of analysis

Sponsors and collaborators

Lead sponsor

Università degli Studi di Sassari

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: May 28, 2021
Registry last updated: May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed