Remineralization Effect of Fluoride Varnishes on Permanent Molars

October 11, 2019 updated by: Merve Erkmen Almaz, Kırıkkale University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kırıkkale, Turkey, 71200
        • Kırıkkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subject has at least one fully erupted permanent first molar tooth

Exclusion Criteria:

Subject has a permanent first molar tooth with visible cavitation on the tooth surface Subject has a partially erupted permanent first molar tooth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sodium fluoride
Duraphat Varnish containing 5% Sodium fluoride
Drug: Sodium Fluoride
Sodium Fluoride varnish was applied to the targeted teeth at baseline, one and three months.
Experimental: Tricalcium phosphate
Clinpro™ White Varnish containing 5% NaF with TCP
Drug: Tricalcium Phosphate
Varnish with Tricalcium Phosphate was applied to the targeted teeth at baseline, one and three months.
Experimental: Xylitol-coated calcium and phosphate
Embrace ™ Varnish containing 5% NaF with CXP
Drug: Xylitol-coated calcium and phosphate
Varnish with Xylitol-coated calcium and phosphate was applied to the targeted teeth at baseline, one and three months.
Experimental: Casein phosphopeptide amorphous calcium phosphate
MI Varnish containing 5% NaF with CPP-ACP
Drug: Casein phosphopeptide amorphous calcium phosphate
Varnish with Casein phosphopeptide amorphous calcium phosphate was applied to the targeted teeth at baseline, one and three months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One, three, six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kırıkkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Kırıkkale pedodontics

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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