Remineralization Effect of Fluoride Varnishes on Permanent Molars

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: Completed
• Conditions: Remineralization
• Intervention / Treatment: Drug: Sodium Fluoride; Drug: Tricalcium Phosphate; Drug: Xylitol-coated calcium and phosphate; Drug: Casein phosphopeptide amorphous calcium phosphate

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kırıkkale, Turkey, 71200
    • Kırıkkale University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Kırıkkale University

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2017
• Primary Completion (Actual): February 8, 2018
• Study Completion (Actual): February 15, 2018

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Cariostatic Agents; Chelating Agents; Sequestering Agents; Calcium; Listerine; Fluorides; Sodium Fluoride; Calcium, Dietary; Caseins
• Other Study ID 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