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.

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).

Study Overview

• Status: Completed
• Conditions: Caries
• Intervention / Treatment: Other: Toothpaste use

• Study Type: Interventional
• Enrollment (Actual): 610
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • SS
    • Sassari, SS, Italy, 07100
      • University of Sassari, Dept of Surgery, Microsurtgery and Medicine Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: Toothpaste use; Brushing three times a day
Active Comparator: 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).	Other: Toothpaste use; Brushing three times a day
Experimental: 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).	Other: Toothpaste use; Brushing three times a day
Active Comparator: 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).	Other: Toothpaste use; Brushing three times a day

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Università degli Studi di Sassari

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Toothpaste, hydroxyapatite, Fluoride, Dental Caries, RCT, Children
• Other Study ID Numbers: USassari02.2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No