Remineralization Effect of Fluoride Varnishes on Permanent Molars

NCT ID: NCT04124887

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-03

Study Completion Date

2018-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Remineralization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sodium fluoride

Duraphat Varnish containing 5% Sodium fluoride

Group Type ACTIVE_COMPARATOR

Sodium Fluoride

Intervention Type DRUG

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

Tricalcium phosphate

Clinpro™ White Varnish containing 5% NaF with TCP

Group Type EXPERIMENTAL

Tricalcium Phosphate

Intervention Type DRUG

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

Xylitol-coated calcium and phosphate

Embrace ™ Varnish containing 5% NaF with CXP

Group Type EXPERIMENTAL

Xylitol-coated calcium and phosphate

Intervention Type 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

MI Varnish containing 5% NaF with CPP-ACP

Group Type EXPERIMENTAL

Casein phosphopeptide amorphous calcium phosphate

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium Fluoride

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

Intervention Type DRUG

Tricalcium Phosphate

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

Intervention Type DRUG

Xylitol-coated calcium and phosphate

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

Intervention Type DRUG

Casein phosphopeptide amorphous calcium phosphate

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kırıkkale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Merve Erkmen Almaz

Asist prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kırıkkale University

Kırıkkale, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Kırıkkale pedodontics

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.