Status:
COMPLETED
The Preventive Effect of 2-years Use of Hydroxyapatite Containing Toothpastes in Children.
Lead Sponsor:
Università degli Studi di Sassari
Conditions:
Caries
Eligibility:
All Genders
4-8 years
Phase:
NA
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 tota...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT04906291
Start Date
February 1 2018
End Date
October 31 2020
Last Update
May 28 2021
Active Locations (1)
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1
University of Sassari, Dept of Surgery, Microsurtgery and Medicine Sciences
Sassari, SS, Italy, 07100