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

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04906291
• Other study ID #: USassari02.2017
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: May 2021
• Source: Università degli Studi di Sassari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: October 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries

Intervention

Other:
• Toothpaste use
Brushing three times a day

Locations

Country	Name	City	State
Italy	University of Sassari, Dept of Surgery, Microsurtgery and Medicine Sciences	Sassari	SS

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Sassari

Country where clinical trial is conducted

Italy, 

Outcome

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