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Completed

NCT Number: NCT04124887

Remineralization Effect of Fluoride Varnishes on Permanent Molars

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.

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Key information

Conditions

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırıkkale University

Kirikkale, 71200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Fluoride

Drug

Sodium Fluoride varnish was applied to the targeted teeth at baseline, one and three months.

Tricalcium Phosphate

Drug

Varnish with Tricalcium Phosphate was applied to the targeted teeth at baseline, one and three months.

Xylitol-coated calcium and phosphate

Drug

Varnish with Xylitol-coated calcium and phosphate was applied to the targeted teeth at baseline, one and three months.

Casein phosphopeptide amorphous calcium phosphate

Drug

Varnish with Casein phosphopeptide amorphous calcium phosphate was applied to the targeted teeth at baseline, one and three months.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 14, 2019
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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