Motivational Effect of Choosing Taste of te Fluoride Varnish on Behavior During Dental Visit in Children - RCT
Condition: Child Behavior
Study type: Interventional

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.
    

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.
    

Intervention name(s): effect of choice on cooperation (pseudoalternative); given fluoride varnish (control)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): fake alternative
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cooperation; pediatric dentistry; behavior management; fluoride varnish