RemineralizationNCT04124887
Remineralization Effect of Fluoride Varnishes on Permanent Molars
A study testing Sodium Fluoride, Tricalcium Phosphate and Xylitol-coated calcium and phosphate in people with Remineralization, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate and compare the efficacy of NaF, NaF with TCP, NaF with CPP-ACP, and NaF with CXP varnishes on newly erupted first permanent molar teeth. The study was carried out in 40 healthy, high caries risk children (DMFS >8), aged six to seven years with newly erupted permanent first molars… Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Remineralization
- What is being tested?
- Sodium Fluoride, Tricalcium Phosphate and Xylitol-coated calcium and phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2017to 15 Feb 2018
- 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 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject has at least one fully erupted permanent first molar tooth
Who cannot join
- Subject has a permanent first molar tooth with visible cavitation on the tooth surface Subject has a partially erupted permanent first molar tooth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remineralization Effect of NaF, NaF With TCP, NaF With CPP-ACP, and NaF With CXP Varnishes on Newly Erupted First Permanent Molars: a Randomised Controlled Trial
The aim of this study was to evaluate and compare the efficacy of NaF, NaF with TCP, NaF with CPP-ACP, and NaF with CXP varnishes on newly erupted first permanent molar teeth. The study was carried out in 40 healthy, high caries risk children (DMFS >8), aged six to seven years with newly erupted permanent first molars who referred to the Pediatric Dentistry Clinic of Kırıkkale University Faculty of Dentistry, Kırıkkale, Turkey. A total of 140 teeth were divided randomly into four groups and the varnishes were applied to the determined teeth at baseline, one and three months. The same varnish was used, if there is more than one first molar to be applied of the same patient. The groups were comprised as follows:
Group 1: Duraphat Varnish containing 5% NaF (Colgate-Palmolive, NSW, Australia) (n = 35), Group 2: Clinpro™ White Varnish containing 5% NaF with TCP (3M ESPE, MN, USA) (n = 35), Group 3: Embrace ™ Varnish containing 5% NaF with CXP (Pulpdent, MA, USA) (n = 35), Group 4: MI Varnish containing 5% NaF with CPP-ACP (GC, Tokyo, Japan) (n = 35). All dental treatments of the patients were completed before the varnish application and oral hygiene instructions were given to all children at the start of the study.
Patients were called for follow up appointments at 1, 3 and 6 months, and in the follow-up period DIAGNOdent device (laser fluorescence scanning) was used to monitor mineralization changes. LF measurements were made at baseline (T0), after one month (T1) three months (T2) and six months (T3). Within and between group comparisons were analysed statistically.
- Conditions
- Remineralization
- Being tested
- Sodium Fluoride, Tricalcium Phosphate, Xylitol-coated calcium and phosphate, Casein phosphopeptide amorphous calcium phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium FluorideDrug
Sodium Fluoride varnish was applied to the targeted teeth at baseline, one and three months.
Tricalcium PhosphateDrug
Varnish with Tricalcium Phosphate was applied to the targeted teeth at baseline, one and three months.
Xylitol-coated calcium and phosphateDrug
Varnish with Xylitol-coated calcium and phosphate was applied to the targeted teeth at baseline, one and three months.
Casein phosphopeptide amorphous calcium phosphateDrug
Varnish with Casein phosphopeptide amorphous calcium phosphate was applied to the targeted teeth at baseline, one and three months.
| Study group | Role | What they receive |
|---|---|---|
| Sodium fluoride | Active comparator | Duraphat Varnish containing 5% Sodium fluoride Receives: Drug: Sodium Fluoride |
| Tricalcium phosphate | Experimental | Clinpro™ White Varnish containing 5% NaF with TCP Receives: Drug: Tricalcium Phosphate |
| Xylitol-coated calcium and phosphate | Experimental | Embrace ™ Varnish containing 5% NaF with CXP Receives: Drug: Xylitol-coated calcium and phosphate |
| Casein phosphopeptide amorphous calcium phosphate | Experimental | MI Varnish containing 5% NaF with CPP-ACP Receives: Drug: Casein phosphopeptide amorphous calcium phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring mineralization changes
To monitor mineralization changes on permanent first molars, laser fluorescence scanning method was used with DiagnodentPen device.
Measured: One, three, six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start3 Feb 2017
- Primary completion8 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemineralizationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Erkmen Almaz, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124887
- Sponsor's protocol ID
- Kırıkkale pedodontics
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remineralization Effect of NaF, NaF With TCP, NaF With CPP-ACP, and NaF With CXP Varnishes on Newly Erupted First Permanent Molars: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04124887
- Acronym / sponsor ID
- Kırıkkale pedodontics
- Conditions
- Remineralization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 14 Oct 2019 (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 study was to evaluate and compare the efficacy of NaF, NaF with TCP, NaF with CPP-ACP, and NaF with CXP varnishes on newly erupted first permanent molar teeth. The study was carried out in 40 healthy, high caries risk children (DMFS >8), aged six to seven years with newly erupted permanent first molars who referred to the Pediatric Dentistry Clinic of Kırıkkale University Faculty of Dentistry, Kırıkkale, Turkey. A total of 140 teeth were divided randomly into four groups and the varnishes were applied to the determined teeth at baseline, one and three months. The same varnish was used, if there is more than one first molar to be applied of the same patient. The groups were comprised as follows:
Group 1: Duraphat Varnish containing 5% NaF (Colgate-Palmolive, NSW, Australia) (n = 35), Group 2: Clinpro™ White Varnish containing 5% NaF with TCP (3M ESPE, MN, USA) (n = 35), Group 3: Embrace ™ Varnish containing 5% NaF with CXP (Pulpdent, MA, USA) (n = 35), Group 4: MI Varnish containing 5% NaF with CPP-ACP (GC, Tokyo, Japan) (n = 35). All dental treatments of the patients were completed before the varnish application and oral hygiene instructions were given to all children at the start of the study.
Patients were called for follow up appointments at 1, 3 and 6 months, and in the follow-up period DIAGNOdent device (laser fluorescence scanning) was used to monitor mineralization changes. LF measurements were made at baseline (T0), after one month (T1) three months (T2) and six months (T3). Within and between group comparisons were analysed statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sodium fluoride | Active comparator | Drug: Sodium FluorideDuraphat Varnish containing 5% Sodium fluoride |
| Tricalcium phosphate | Experimental | Drug: Tricalcium PhosphateClinpro™ White Varnish containing 5% NaF with TCP |
| Xylitol-coated calcium and phosphate | Experimental | Drug: Xylitol-coated calcium and phosphateEmbrace ™ Varnish containing 5% NaF with CXP |
| Casein phosphopeptide amorphous calcium phosphate | Experimental | Drug: Casein phosphopeptide amorphous calcium phosphateMI Varnish containing 5% NaF with CPP-ACP |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subject has at least one fully erupted permanent first molar tooth
Key exclusion criteria (1 listed)
- Subject has a permanent first molar tooth with visible cavitation on the tooth surface Subject has a partially erupted permanent first molar tooth.
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 FluorideSodium Fluoride varnish was applied to the targeted teeth at baseline, one and three months. | Drug | Sodium fluoride |
| Tricalcium PhosphateVarnish with Tricalcium Phosphate was applied to the targeted teeth at baseline, one and three months. | Drug | Tricalcium phosphate |
| Xylitol-coated calcium and phosphateVarnish with Xylitol-coated calcium and phosphate was applied to the targeted teeth at baseline, one and three months. | Drug | Xylitol-coated calcium and phosphate |
| Casein phosphopeptide amorphous calcium phosphateVarnish with Casein phosphopeptide amorphous calcium phosphate was applied to the targeted teeth at baseline, one and three months. | Drug | Casein phosphopeptide amorphous calcium phosphate |
Primary outcome
Monitoring mineralization changes
Time frame: One, three, six months
To monitor mineralization changes on permanent first molars, laser fluorescence scanning method was used with DiagnodentPen device.
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 15 Oct 2019.
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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 Sodium Fluoride, Tricalcium Phosphate and Xylitol-coated calcium and phosphate in people with Remineralization, run by Kırıkkale University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 15 Oct 2019. 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 Turkey (Türkiye). 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?
Monitoring mineralization changes (time frame: One, three, six months). 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 15 Oct 2019.