Remineralization Effect of Fluoride Varnishes on Permanent Molars

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Remineralization

Intervention / Treatment
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* Drug: Sodium Fluoride
* Drug: Tricalcium Phosphate
* Drug: Xylitol-coated calcium and phosphate
* Drug: Casein phosphopeptide amorphous calcium phosphate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium fluoride<br>Duraphat Varnish containing 5% Sodium fluoride | Drug: Sodium Fluoride<br>* Sodium Fluoride varnish was applied to the targeted teeth at baseline, one and three months.<br>|
| Experimental: Tricalcium phosphate<br>Clinpro™ White Varnish containing 5% NaF with TCP | Drug: Tricalcium Phosphate<br>* Varnish with Tricalcium Phosphate was applied to the targeted teeth at baseline, one and three months.<br>|
| Experimental: Xylitol-coated calcium and phosphate<br>Embrace ™ Varnish containing 5% NaF with CXP | Drug: Xylitol-coated calcium and phosphate<br>* Varnish with Xylitol-coated calcium and phosphate was applied to the targeted teeth at baseline, one and three months.<br>|
| Experimental: Casein phosphopeptide amorphous calcium phosphate<br>MI Varnish containing 5% NaF with CPP-ACP | Drug: Casein phosphopeptide amorphous calcium phosphate<br>* Varnish with Casein phosphopeptide amorphous calcium phosphate was applied to the targeted teeth at baseline, one and three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring mineralization changes | To monitor mineralization changes on permanent first molars, laser fluorescence scanning method was used with DiagnodentPen device. | One, three, six months |