Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05285228 |
| Other study ID # |
BB 180/21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 17, 2022 |
| Est. completion date |
October 1, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
University Medicine Greifswald |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
