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

NCT04906291 | Completed DMC

• 1 other identifier: USassari02.2017
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Caries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Caries Progression rate

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

  2 year

Study Arms (4)

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

EXPERIMENTAL

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

Other: Toothpaste use

Fluoridated toothpaste (1000 ppm F-)

ACTIVE COMPARATOR

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

Other: Toothpaste use

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

EXPERIMENTAL

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

Other: Toothpaste use

Fluoridated toothpaste (1450 ppm F-)

ACTIVE COMPARATOR

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

Other: Toothpaste use

Interventions

Toothpaste use OTHER

Brushing three times a day

Fluoridated toothpaste (1000 ppm F-); Fluoridated toothpaste (1450 ppm F-); H.A.F. toothpaste (1000 ppm F-); H.A.F. toothpaste (1450 ppm F-)

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (1)

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

Sassari, SS, 07100, Italy

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Preventive Dentistry

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 28, 2021
• Study Start: February 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: October 31, 2020
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)