Remineralization Effect of Fluoride Varnishes on Permanent Molars

Remineralization Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124887
• Other study ID #: Kirikkale pedodontics
• Status: Completed
• Phase: N/A
• Start date: February 3, 2017
• Est. completion date: February 15, 2018

Study information

• Verified date: October 2019
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 15, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Remineralization

Intervention

Drug:
• Sodium Fluoride
Sodium Fluoride varnish was applied to the targeted teeth at baseline, one and three months.
• Tricalcium Phosphate
Varnish with Tricalcium Phosphate was applied to the targeted teeth at baseline, one and three months.
• Xylitol-coated calcium and phosphate
Varnish with Xylitol-coated calcium and phosphate was applied to the targeted teeth at baseline, one and three months.
• Casein phosphopeptide amorphous calcium phosphate
Varnish with Casein phosphopeptide amorphous calcium phosphate was applied to the targeted teeth at baseline, one and three months.

Locations

Country	Name	City	State
Turkey	Kirikkale University	Kirikkale

Sponsors (1)

Lead Sponsor	Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring mineralization changes	To monitor mineralization changes on permanent first molars, laser fluorescence scanning method was used with DiagnodentPen device.	One, three, six months