Remineralization Effect of Fluoride Varnishes on Permanent Molars

NCT04124887 | Completed DMC

• 1 other identifier: Kırıkkale pedodontics
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Remineralization

Outcome Measures

Primary Outcomes (1)

• Monitoring mineralization changes

  To monitor mineralization changes on permanent first molars, laser fluorescence scanning method was used with DiagnodentPen device.

  One, three, six months

Study Arms (4)

Sodium fluoride

ACTIVE COMPARATOR

Duraphat Varnish containing 5% Sodium fluoride

Drug: Sodium Fluoride

Tricalcium phosphate

EXPERIMENTAL

Clinpro™ White Varnish containing 5% NaF with TCP

Drug: Tricalcium Phosphate

Xylitol-coated calcium and phosphate

EXPERIMENTAL

Embrace ™ Varnish containing 5% NaF with CXP

Drug: Xylitol-coated calcium and phosphate

Casein phosphopeptide amorphous calcium phosphate

EXPERIMENTAL

MI Varnish containing 5% NaF with CPP-ACP

Drug: Casein phosphopeptide amorphous calcium phosphate

Interventions

Sodium Fluoride DRUG

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

Sodium fluoride

Tricalcium Phosphate DRUG

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

Tricalcium phosphate

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.

Xylitol-coated calcium and phosphate

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.

Casein phosphopeptide amorphous calcium phosphate

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subject has at least one fully erupted permanent first molar tooth

You may not qualify if:

• Subject has a permanent first molar tooth with visible cavitation on the tooth surface Subject has a partially erupted permanent first molar tooth.

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale University

Kırıkkale, 71200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Sodium Fluoride; tricalcium phosphate; Phosphates; casein phosphopeptide-amorphous calcium phosphate nanocomplex

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Anions; Ions; Electrolytes; Phosphorus Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist prof

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 14, 2019
• Study Start: February 3, 2017
• Primary Completion: February 8, 2018
• Study Completion: February 15, 2018
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

TU (1)