Remineralization Effect of Fluoride Varnishes on Permanent Molars

Not Applicable

Completed

• Conditions: Remineralization
• Interventions: Drug: Casein phosphopeptide amorphous calcium phosphate; Drug: Xylitol-coated calcium and phosphate; Drug: Tricalcium Phosphate; Drug: Sodium Fluoride

• Registration Number: NCT04124887
• Lead Sponsor: Kırıkkale University

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-03
• Primary Completion: 2018-02-08
• Study Completion: 2018-02-15
• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Last Update Submitted: 2019-10-11
• Study First Posted: 2019-10-14
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Casein phosphopeptide amorphous calcium phosphate	Casein phosphopeptide amorphous calcium phosphate	MI Varnish containing 5% NaF with CPP-ACP
Xylitol-coated calcium and phosphate	Xylitol-coated calcium and phosphate	Embrace ™ Varnish containing 5% NaF with CXP
Tricalcium phosphate	Tricalcium Phosphate	Clinpro™ White Varnish containing 5% NaF with TCP
Sodium fluoride	Sodium Fluoride	Duraphat Varnish containing 5% Sodium fluoride

Primary Outcome Measures

Name	Time	Method
Monitoring mineralization changes	One, three, six months	To monitor mineralization changes on permanent first molars, laser fluorescence scanning method was used with DiagnodentPen device.

Trial Locations

Locations (1)

Kırıkkale University; 🇹🇷 Kırıkkale, Turkey