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

NCT ID: NCT04906291

Last Updated: 2021-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

610 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Caries

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

Toothpaste use

Intervention Type OTHER

Brushing three times a day

Fluoridated toothpaste (1000 ppm F-)

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

Group Type ACTIVE_COMPARATOR

Toothpaste use

Intervention Type OTHER

Brushing three times a day

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

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

Group Type EXPERIMENTAL

Toothpaste use

Intervention Type OTHER

Brushing three times a day

Fluoridated toothpaste (1450 ppm F-)

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

Group Type ACTIVE_COMPARATOR

Toothpaste use

Intervention Type OTHER

Brushing three times a day

Interventions

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Toothpaste use

Brushing three times a day

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Università degli Studi di Sassari

OTHER

Sponsor Role lead

Responsible Party

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Guglielmo Campus

Associate Professor in Preventive Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Sassari, SS, Italy

Site Status

Countries

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Italy

Other Identifiers

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USassari02.2017

Identifier Type: -

Identifier Source: org_study_id