CariesNCT04906291
The Preventive Effect of 2-years Use of Hydroxyapatite Containing Toothpastes in Children.
A study testing Toothpaste use in people with Caries, run by Università degli Studi di Sassari at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Toothpaste use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2018to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Sassari, Dept of Surgery, Microsurtgery and Medicine Sciences
Sassari, SS, 07100
About this study
Official title: 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).
- Conditions
- Caries
- Being tested
- Toothpaste use
- Keywords
- Toothpaste, hydroxyapatite, Fluoride, Dental Caries, RCT, Children
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste useOther
Brushing three times a day
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Other: Toothpaste use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries Progression rate
. Caries incidence rate was calculated on each tooth (primary and permanent) as the unit of analysis
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Feb 2018
- Primary completion30 Jun 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guglielmo Campus, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906291
- Sponsor's protocol ID
- USassari02.2017
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Caries Preventive Effect of 2-years Use of Hydroxyapatite Containing Toothpastes in Children. A Triple-blind Randomized Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04906291
- Acronym / sponsor ID
- USassari02.2017
- Conditions
- Caries
- Keywords
- Toothpaste, hydroxyapatite, Fluoride, Dental Caries, RCT, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| H.A.F. toothpaste (1000 ppm F-) | Experimental | Other: Toothpaste useThe children were instructed to brush their teeth for at least two minutes after each main meal (three times/day). |
| Fluoridated toothpaste (1000 ppm F-) | Active comparator | Other: Toothpaste useThe subjects were instructed to brush their teeth for at least two minutes after each main meal (three times/day). |
| H.A.F. toothpaste (1450 ppm F-) | Experimental | Other: Toothpaste useThe subjects were instructed to brush their teeth for at least two minutes after each main meal (three times/day). |
| Fluoridated toothpaste (1450 ppm F-) | Active comparator | Other: Toothpaste useThe subjects were instructed to brush their teeth for at least two minutes after each main meal (three times/day). |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothpaste useBrushing three times a day | Other | Fluoridated toothpaste (1000 ppm F-), Fluoridated toothpaste (1450 ppm F-), H.A.F. toothpaste (1000 ppm F-), H.A.F. toothpaste (1450 ppm F-) |
Primary outcome
Caries Progression rate
Time frame: 2 year
. Caries incidence rate was calculated on each tooth (primary and permanent) as the unit of analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste use in people with Caries, run by Università degli Studi di Sassari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries Progression rate (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.