Remineralization Effect of Fluoride Varnishes on Permanent Molars

Kırıkkale University

Status: Completed

Conditions: Remineralization

Treatments: Drug: Xylitol-coated calcium and phosphate; Drug: Casein phosphopeptide amorphous calcium phosphate; Drug: Sodium Fluoride; Drug: Tricalcium Phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT04124887

Kırıkkale pedodontics

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 6 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups

Sodium fluoride

Active Comparator group

Description:

Duraphat Varnish containing 5% Sodium fluoride

Treatment:

Drug: Sodium Fluoride

Tricalcium phosphate

Experimental group

Description:

Clinpro™ White Varnish containing 5% NaF with TCP

Treatment:

Drug: Tricalcium Phosphate

Xylitol-coated calcium and phosphate

Experimental group

Description:

Embrace ™ Varnish containing 5% NaF with CXP

Treatment:

Drug: Xylitol-coated calcium and phosphate

Casein phosphopeptide amorphous calcium phosphate

Experimental group

Description:

MI Varnish containing 5% NaF with CPP-ACP

Treatment:

Drug: Casein phosphopeptide amorphous calcium phosphate