Child BehaviorNCT05285228
Motivational Effect of Choosing Taste of te Fluoride Varnish on Behavior During Dental Visit in Children - RCT
A study testing effect of choice on cooperation (pseudoalternative) in people with Child Behavior, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior
- What is being tested?
- effect of choice on cooperation (pseudoalternative)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 17 Feb 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 5 - 10 years.
- Clinical presentation due to a dental appointment, in which an application of fluoride varnish is planned.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motivational Effect of Choosing the Taste of te Fluoride Varnish on Acceptance and Behavior During Dental Visit in Children - a Single Blind RCT
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.
Read the detailed description
The main assumption of the study is giving the child the option to choose e.g. their preferred taste of the fluoride varnish possibly moves the focus away from not being willing to receive the fluoride varnish application to rather accepting it (pseudoalternative).
The aim of this study is to investigate the impact of participation via choosing the taste of the fluoride varnish (locus of control and pseudo-alternative) on the acceptance and cooperation during dental visit in schoolchildren aged 5 to 10 years.
This two-parallel arm single-blind randomized controlled clinical trial will be undertaken at the Department of Preventive and Pediatric Dentistry at the University of Greifswald from approximately January 2022 to Autumn 2022. The child will be randomly allocated using simple random sampling with the use of random table method, in which 35 randomly generated serial numbers for each group will be generated by Windows Microsoft Excel (2010, USA) to ensure equal randomization of each group.
The test group will receive a previously allocated flavor of fluoride varnish (Profluorid VOCO, Germany) ranging from (Melon, Caramel, Cherry, Bubble gum, Mint) containing 22,500 ppm fluoride. However the test group will be receiving the choosing the taste of the previously mentioned fluoride varnish r with flavor ranging from (Melon, Caramel, Cherry, Bubble gum, Mint). After allocation an independent observer enters the dental treatment room for blinded assessment. After the dental visit, the participating child, the accompanying parent or caregiver, the dental operator and the blinded assessor receive a short questionnaire to be filled out.
Patients presenting with acute pain or with signs and symptoms, which should be treated will not be asked to participate. Moreover Systemic diseases that require special attention during their dental treatment or Parents/children who refused to participate in the study, and reported allergy against ingredients of the toothpaste are excluded from participation.
Assessment would be done firstly by observing participants' behavior and then categorized using the Frankl's behavior rating scale-FRS (Frankl, 1962) by an independent blinded observer, and the accompanying parent.
Secondly, The dental anxiety level of the child using the facial image scale (FIS) consists of a row of five gray scale faces ranging from very happy to very unhappy, moreover a questionnaire will be filled out by the caregivers (including questions on demographic issues) on their acceptance and preference regarding the choice of the taste of the fluoride varnish.
Further data of the child for better description of the baseline characteristics of the participants will be taken from the documentation in the patient's file: e.g. age, sex, dmft / DMFT, history of dental anxiety, history of invasive dental treatment e.g. nitrous oxide sedation or dental general anesthesia.
- Conditions
- Child Behavior
- Being tested
- effect of choice on cooperation (pseudoalternative), given fluoride varnish (control)
- Keywords
- cooperation, pediatric dentistry, behavior management, fluoride varnish
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
effect of choice on cooperation (pseudoalternative)Behavioural
Also called fake alternative
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.
given fluoride varnish (control)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group: allocation to specific taste of fluoride varnish | Active comparator | allocation to specific taste of fluoride varnish Receives: Behavioral: given fluoride varnish (control) |
| Test group: child chooses taste of fluoride varnish | Experimental | child chooses taste of fluoride varnish before dental treatment Receives: Behavioral: effect of choice on cooperation (pseudoalternative) |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptance of dental treatment
measurement via Frankl behavioral scale;
Measured: 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
patient rates the acceptance of the taste of the fluoride varnish with a facial image scale (from definitely negative to definitely positive: codes 1 to 5)
Measured: assessment right after the end dental visit by the child; immediately, this means within about 1 minute after the application of the varnish
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start17 Feb 2022
- Primary completion15 Jul 2022
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Ramiar, Principal investigator, University of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285228
- Sponsor's protocol ID
- BB 180/21
- Status last verified
- Jan 2024
- First submitted
- 15 Feb 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39898776
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Effect of Choosing the Taste of te Fluoride Varnish on Acceptance and Behavior During Dental Visit in Children - a Single Blind RCT
- ClinicalTrials.gov ID
- NCT05285228
- Acronym / sponsor ID
- BB 180/21
- Conditions
- Child Behavior
- Keywords
- cooperation, pediatric dentistry, behavior management, fluoride varnish
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main assumption of the study is giving the child the option to choose e.g. their preferred taste of the fluoride varnish possibly moves the focus away from not being willing to receive the fluoride varnish application to rather accepting it (pseudoalternative).
The aim of this study is to investigate the impact of participation via choosing the taste of the fluoride varnish (locus of control and pseudo-alternative) on the acceptance and cooperation during dental visit in schoolchildren aged 5 to 10 years.
This two-parallel arm single-blind randomized controlled clinical trial will be undertaken at the Department of Preventive and Pediatric Dentistry at the University of Greifswald from approximately January 2022 to Autumn 2022. The child will be randomly allocated using simple random sampling with the use of random table method, in which 35 randomly generated serial numbers for each group will be generated by Windows Microsoft Excel (2010, USA) to ensure equal randomization of each group.
The test group will receive a previously allocated flavor of fluoride varnish (Profluorid VOCO, Germany) ranging from (Melon, Caramel, Cherry, Bubble gum, Mint) containing 22,500 ppm fluoride. However the test group will be receiving the choosing the taste of the previously mentioned fluoride varnish r with flavor ranging from (Melon, Caramel, Cherry, Bubble gum, Mint). After allocation an independent observer enters the dental treatment room for blinded assessment. After the dental visit, the participating child, the accompanying parent or caregiver, the dental operator and the blinded assessor receive a short questionnaire to be filled out.
Patients presenting with acute pain or with signs and symptoms, which should be treated will not be asked to participate. Moreover Systemic diseases that require special attention during their dental treatment or Parents/children who refused to participate in the study, and reported allergy against ingredients of the toothpaste are excluded from participation.
Assessment would be done firstly by observing participants' behavior and then categorized using the Frankl's behavior rating scale-FRS (Frankl, 1962) by an independent blinded observer, and the accompanying parent.
Secondly, The dental anxiety level of the child using the facial image scale (FIS) consists of a row of five gray scale faces ranging from very happy to very unhappy, moreover a questionnaire will be filled out by the caregivers (including questions on demographic issues) on their acceptance and preference regarding the choice of the taste of the fluoride varnish.
Further data of the child for better description of the baseline characteristics of the participants will be taken from the documentation in the patient's file: e.g. age, sex, dmft / DMFT, history of dental anxiety, history of invasive dental treatment e.g. nitrous oxide sedation or dental general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: allocation to specific taste of fluoride varnish | Active comparator | Behavioral: given fluoride varnish (control)allocation to specific taste of fluoride varnish |
| Test group: child chooses taste of fluoride varnish | Experimental | Behavioral: effect of choice on cooperation (pseudoalternative)child chooses taste of fluoride varnish before dental treatment |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged between 5 - 10 years.
- Clinical presentation due to a dental appointment, in which an application of fluoride varnish is planned.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| effect of choice on cooperation (pseudoalternative)Also: fake alternativeFor 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. | Behavioural | Test group: child chooses taste of fluoride varnish |
| given fluoride varnish (control)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. | Behavioural | Control group: allocation to specific taste of fluoride varnish |
Primary outcome
acceptance of dental treatment
Time frame: 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
measurement via Frankl behavioral scale;
1 secondary outcome
acceptance of taste of fluoride varnish
Time frame: assessment right after the end dental visit by the child; immediately, this means within about 1 minute after the application of the varnish
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 39898776Karim 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.
- Individual participant dataSharing planned: No
Related trials for Child Behavior
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
Study of Psychoeducation and Reading for Kids (SPARK)
Reading Difficulties, Behavioral Problems
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Ramiar principal investigator
University of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing effect of choice on cooperation (pseudoalternative) in people with Child Behavior, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acceptance of dental treatment (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05285228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.