NCT05285228

Brief Summary

To assess the influence of the choice of fluoride varnish flavor on the acceptance and cooperation in schoolchildren between (5-10) years during the dental visit, in which an application of fluoride varnish is indicated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

February 17, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

February 15, 2022

Last Update Submit

January 8, 2024

Conditions

Child Behavior

Keywords

cooperationpediatric dentistrybehavior managementfluoride varnish

Outcome Measures

Primary Outcomes (1)

  • acceptance of dental treatment

    measurement via Frankl behavioral scale;

    assessment during the dental visit via independent observer; usually the dental visit does not exceed more than 30 minutes; the overall behavior is rated during this time period

Secondary Outcomes (1)

  • acceptance of taste of fluoride varnish

    assessment right after the end dental visit by the child; immediately, this means within about 1 minute after the application of the varnish

Other Outcomes (1)

  • parental acceptance regarding the use of the fluoride varnish

    questionnaire is filled out right after the end of the dental visit by the parent, immediately, this means within about 1 minute after the application of the varnish

Study Arms (2)

Control group: allocation to specific taste of fluoride varnish

ACTIVE COMPARATOR

allocation to specific taste of fluoride varnish

Behavioral: given fluoride varnish (control)

Test group: child chooses taste of fluoride varnish

EXPERIMENTAL

child chooses taste of fluoride varnish before dental treatment

Behavioral: effect of choice on cooperation (pseudoalternative)

Interventions

effect of choice on cooperation (pseudoalternative)BEHAVIORAL

For the test group, before the standard check-up starts, the participant is given the choice of selecting the taste of the fluoride varnish (Profluorid VOCO, Germany) from a range of about five flavors (Melon, Caramel, Cherry, Bubble gum, Mint), which will be applied at the end of the visit. Post-placement instructions provided by the manufacturer will be given to the caregiver and the child and questionnaires will be handed out.

Also known as: fake alternative
Test group: child chooses taste of fluoride varnish
given fluoride varnish (control)BEHAVIORAL

For the control group the participant is provided with a given taste of the fluoride varnish (Profluorid VOCO, Germany) from a range of about five flavors (Melon, Caramel, Cherry, Bubble gum, Mint) according to the randomization list.

Control group: allocation to specific taste of fluoride varnish

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 5 - 10 years.
  • Clinical presentation due to a dental appointment, in which an application of fluoride varnish is planned.

You may not qualify if:

  • Patients presented with acute pain/ patients with signs or symptoms to be treated.
  • Patients reported with systemic diseases that require special attention during their dental treatment.
  • Parents or children, who refuse participation in the study.
  • Reported Allergy against ingredients of the toothpaste or the fluoride varnish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Clinics University of Greifswald

Greifswald, 17475, Germany

Location

Related Publications (1)

  • Karim R, Splieth CH, Schmoeckel J. Effect of Choice of Flavor of Fluoride Varnish on Behavior in Dental Visits in Schoolchildren. Clin Exp Dent Res. 2025 Feb;11(1):e70069. doi: 10.1002/cre2.70069.

    PMID: 39898776DERIVED

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Karim Ramiar

    University of Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor enters the room to observe the dental treatment after the allocation to the group when the fluoride varnish is placed ready.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2022

First Posted

March 17, 2022

Study Start

February 17, 2022

Primary Completion

July 15, 2022

Study Completion

October 1, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)