Early Childhood CariesNCT03625310
Effectiveness Fluoride Varnishes in Children With Early Childhood Caries
A study testing Sodium Fluoride, Sodium Fluoride with TCP and Sodium Fluoride with CXP in people with Early Childhood Caries, run by Merve Erkmen Almaz.
Trial summary
The study was carried out in 88 children with severe early childhood caries (dmfs≥age +1) who were referred to the investigators' clinic. Patients who completed dental treatment under general anesthesia in a single session, were included to the study. Read more about this study
- Who is it for?
- Ages 36 to 72 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Sodium Fluoride, Sodium Fluoride with TCP and Sodium Fluoride with CXP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2017
- 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 36 to 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- clinical diagnosis of healthy children with severe early childhood caries,
- younger than 6 years in the primary dentition
Who cannot join
- history of any chronic disease,
- use of any drugs that reduce salivary flow or antibiotics in the last 4 weeks,
- use of systemic fluoride tablets
About this study
Official title: Effectiveness of Different Fluoride Varnishes on Salivary Bacteria Levels in Children With Early Childhood Caries
The study was carried out in 88 children with severe early childhood caries (dmfs≥age +1) who were referred to the investigators' clinic. Patients who completed dental treatment under general anesthesia in a single session, were included to the study.
Patients were divided randomly into 4 groups and after dental treatment one of the fluoride varnish listed below was applied to each child. The groups were as follows;
Read more
- Duraphat varnish containing 5% Sodium Fluoride (Colgate) (n = 22),
- Clinpro ™ White Varnish containing 5% of Sodium Fluoride tricalcium phosphate (3M ESPE) (n = 22),
- Embrace ™ Varnish containing 5% Sodium Fluoride with CXP ™ (Pulpdent) (n = 22),
- MI Varnish containing 5% Sodium Fluoride casein phosphopeptide amorphous calcium phosphate varnish (GC) (n = 22).
Saliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva samples before general anaesthesia; one month after treatment and three months after treatment.
Read the detailed description
Duraphat (Colgate), which we used as a positive control group in our study, contains only 5% sodium fluoride. It has been reported in studies that Duraphat is effective in remineralization.
Clinpro ™ White Varnish, another topical varnish in this study,was reported to be effective for caries prevention in pre-school children.
One of the varnishes we evaluate in the study, Embrace™ Varnish, contains 5% sodium fluoride with xylitol-coated calcium and phosphate. According to the manufacturer, the xylitol coating prevents the calcium and phosphate salts from reacting until they come in contact with saliva. Saliva dissolves the xylitol and releases the calcium and phosphate ions, which react with the fluoride ions in saliva to form protective fluorapatite on the teeth19 MI Varnish, in the fourth group containing 5% sodium fluoride with casein phosphopeptide amorphous calcium phosphate (CPP-ACP) had a high release of calcium and fluoride ions.
- Conditions
- Early Childhood Caries
- Being tested
- Sodium Fluoride, Sodium Fluoride with TCP, Sodium Fluoride with CXP, Sodium Fluoride with CPP-ACP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium FluorideDrug
Also called Colgate Duraphat varnish
Sodium Fluoride with TCPDrug
Also called Clinpro ™ White Varnish 3M ESPE
Sodium Fluoride with CXPDrug
Also called Embrace ™ Varnish Pulpdent
Sodium Fluoride with CPP-ACPDrug
Also called MI Varnish GC
| Study group | Role | What they receive |
|---|---|---|
| Sodium Fluoride | Active comparator | Varnish containing 5% Sodium Fluoride, was applied to all remaining teeth of each child after dental treatment under general anaesthesia. Receives: Drug: Sodium Fluoride |
| Sodium Fluoride with TCP | Experimental | Varnish containing 5% Sodium Fluoride with tricalcium phosphate (TCP) ,varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia. Receives: Drug: Sodium Fluoride with TCP |
| Sodium Fluoride with CXP | Experimental | Varnish containing 5% Sodium Fluoride with Xylitol-coated Calcium and Phosphate (CXP) ,varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia. Receives: Drug: Sodium Fluoride with CXP |
| Sodium Fluoride with CPP-ACP | Experimental | Varnish containing 5% Sodium Fluoride with casein phosphopeptide amorphous calcium phosphate (CPP-ACP), varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia. Receives: Drug: Sodium Fluoride with CPP-ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of fluoride varnishes on saliva Mutans streptococci (MS) and Lactobacilli (LB) levels were evaluated as colony forming units (CFU).
Saliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva samples using CRT Bacteria (Caries Risk Test, Ivoclar Vivadent)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study startNov 2016
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Childhood 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve Erkmen Almaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merve Erkmen Almaz, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625310
- Sponsor's protocol ID
- Kirikkale University
- Status last verified
- Aug 2018
- First submitted
- 27 Jul 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erkmen Almaz M, Akbay Oba A. Antibacterial activity of fluoride varnishes containing different agents in children with severe early childhood caries: a randomised controlled trial. Clin Oral Investig. 2020 Jun;24(6):2129-2136. doi: 10.1007/s00784-020-03300-w. Epub 2020 Apr 30.
PubMed 32356211
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Fluoride Varnishes on Salivary Bacteria Levels in Children With Early Childhood Caries
- ClinicalTrials.gov ID
- NCT03625310
- Acronym / sponsor ID
- Kirikkale University
- Conditions
- Early Childhood Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Merve Erkmen AlmazUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Aug 2018 (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 study was carried out in 88 children with severe early childhood caries (dmfs≥age +1) who were referred to the investigators' clinic. Patients who completed dental treatment under general anesthesia in a single session, were included to the study.
Patients were divided randomly into 4 groups and after dental treatment one of the fluoride varnish listed below was applied to each child. The groups were as follows;
- Duraphat varnish containing 5% Sodium Fluoride (Colgate) (n = 22),
- Clinpro ™ White Varnish containing 5% of Sodium Fluoride tricalcium phosphate (3M ESPE) (n = 22),
- Embrace ™ Varnish containing 5% Sodium Fluoride with CXP ™ (Pulpdent) (n = 22),
- MI Varnish containing 5% Sodium Fluoride casein phosphopeptide amorphous calcium phosphate varnish (GC) (n = 22).
Saliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva samples before general anaesthesia; one month after treatment and three months after treatment.
Detailed description
Duraphat (Colgate), which we used as a positive control group in our study, contains only 5% sodium fluoride. It has been reported in studies that Duraphat is effective in remineralization.
Clinpro ™ White Varnish, another topical varnish in this study,was reported to be effective for caries prevention in pre-school children.
One of the varnishes we evaluate in the study, Embrace™ Varnish, contains 5% sodium fluoride with xylitol-coated calcium and phosphate. According to the manufacturer, the xylitol coating prevents the calcium and phosphate salts from reacting until they come in contact with saliva. Saliva dissolves the xylitol and releases the calcium and phosphate ions, which react with the fluoride ions in saliva to form protective fluorapatite on the teeth19 MI Varnish, in the fourth group containing 5% sodium fluoride with casein phosphopeptide amorphous calcium phosphate (CPP-ACP) had a high release of calcium and fluoride ions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sodium Fluoride | Active comparator | Drug: Sodium FluorideVarnish containing 5% Sodium Fluoride, was applied to all remaining teeth of each child after dental treatment under general anaesthesia. |
| Sodium Fluoride with TCP | Experimental | Drug: Sodium Fluoride with TCPVarnish containing 5% Sodium Fluoride with tricalcium phosphate (TCP) ,varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia. |
| Sodium Fluoride with CXP | Experimental | Drug: Sodium Fluoride with CXPVarnish containing 5% Sodium Fluoride with Xylitol-coated Calcium and Phosphate (CXP) ,varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia. |
| Sodium Fluoride with CPP-ACP | Experimental | Drug: Sodium Fluoride with CPP-ACPVarnish containing 5% Sodium Fluoride with casein phosphopeptide amorphous calcium phosphate (CPP-ACP), varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia. |
Who may qualify
- Ages
- 36 to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- clinical diagnosis of healthy children with severe early childhood caries,
- younger than 6 years in the primary dentition
Key exclusion criteria (3 listed)
- history of any chronic disease,
- use of any drugs that reduce salivary flow or antibiotics in the last 4 weeks,
- use of systemic fluoride tablets
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 |
|---|---|---|
| Sodium FluorideAlso: Colgate Duraphat varnish | Drug | Sodium Fluoride |
| Sodium Fluoride with TCPAlso: Clinpro ™ White Varnish 3M ESPE | Drug | Sodium Fluoride with TCP |
| Sodium Fluoride with CXPAlso: Embrace ™ Varnish Pulpdent | Drug | Sodium Fluoride with CXP |
| Sodium Fluoride with CPP-ACPAlso: MI Varnish GC | Drug | Sodium Fluoride with CPP-ACP |
Primary outcome
Effect of fluoride varnishes on saliva Mutans streptococci (MS) and Lactobacilli (LB) levels were evaluated as colony forming units (CFU).
Time frame: 3 months
Saliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva samples using CRT Bacteria (Caries Risk Test, Ivoclar Vivadent)
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 10 Aug 2018.
- Derived from this study: PubMed 32356211Erkmen Almaz M, Akbay Oba A. Antibacterial activity of fluoride varnishes containing different agents in children with severe early childhood caries: a randomised controlled trial. Clin Oral Investig. 2020 Jun;24(6):2129-2136. doi: 10.1007/s00784-020-03300-w. Epub 2020 Apr 30.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Fluoride, Sodium Fluoride with TCP and Sodium Fluoride with CXP in people with Early Childhood Caries, run by Merve Erkmen Almaz.
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 2 inclusion and 3 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 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Effect of fluoride varnishes on saliva Mutans streptococci (MS) and Lactobacilli (LB) levels were evaluated as colony forming units (CFU). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03625310, which also lists 1 linked publication.
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 10 Aug 2018.