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

Università degli Studi di Sassari

Status: Completed

Conditions: Caries

Treatments: Other: Toothpaste use

Study type: Interventional

Funder types: Other

Identifiers

NCT04906291

USassari02.2017

Details and patient eligibility

About

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).

Enrollment: 610 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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610 participants in 4 patient groups

H.A.F. toothpaste (1000 ppm F-)

Experimental group

Description:

The children were instructed to brush their teeth for at least two minutes after each main meal (three times/day).

Treatment:

Other: Toothpaste use

Fluoridated toothpaste (1000 ppm F-)

Active Comparator group

Description:

The subjects were instructed to brush their teeth for at least two minutes after each main meal (three times/day).

Treatment:

Other: Toothpaste use

H.A.F. toothpaste (1450 ppm F-)

Experimental group

Description:

The subjects were instructed to brush their teeth for at least two minutes after each main meal (three times/day).

Treatment:

Other: Toothpaste use

Fluoridated toothpaste (1450 ppm F-)

Active Comparator group

Description:

The subjects were instructed to brush their teeth for at least two minutes after each main meal (three times/day).

Treatment:

Other: Toothpaste use