Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05238246 |
| Other study ID # |
2014/461 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2017 |
| Est. completion date |
December 3, 2018 |
Study information
| Verified date |
February 2022 |
| Source |
Istanbul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Dental anxiety causes unwanted distresses in children. The present study is aimed to analyze
using both technological and psychological distraction in children aged 4-10 with a humanoid
robot.
Materials and Methods: One hundred and two children (fifty two girls, fifty boys; mean age:
6.71±1.43 years) were included. Fifty children were participated in robot group and fifty two
children were participated in control. Salivary alpha amylase were analyzed before, after,
and 10 min after treatment. Frankl Behaviour Rating Scale (FBRS), Facial Image Scale (FIS),
salivary amylase levels, and physiological pulse rate were used to assess the stress related
changes. Statistical tests were used with p value fixed at 0.05.
Description:
Selection and description of participants: 115 healthy children aged between 4 and 10 years,
having their first dental visit and requiring a pulpotomy for a primary molar were selected
from Istanbul University, Department of Pediatric Dentistry. The children accepting to
response questionnaires and informed consent, were accompanied by at least one parent was
obtained. Children having any history of systemic diseases or medically compromised were not
included to the study. The study protocol was approved by the Ethical Committee of Istanbul
University (2014/461).
Inclusion criteria were (a) healthy children, (b) no previous dental experience, (c) need
pulpotomy in at least one mandibular primary molar. Exclusion criteria were (a) children
showing definitely negative behaviour (Frankl 1) during dental prophylaxis at the first
visit.
Randomization: A total of 115 patients who met the inclusion criteria were examined. Six
children didn't want to participate for the treatment and five children couldn't spit enough
for saliva collection. From the eligible 104 children were randomly selected and equally
allocated into two groups.
Treatment procedure: The study protocol was explained to parents and their and written
consent was obtained. Pre-treatment questionnaires were asked to the participants. All
children were treated under local anaesthesia. The treatments were performed by the same
dentist (YK). The robot group (RG) were treated with the robot accompaniment (n=50). The
control group (CG) were treated with positive reinforcement and tell-show-do (n=52).
Treatments were completed in the same session. One calibrated pediatric dentist [intra-class
correlation coefficient (ICC) score = 0.87] performed pulpotomy treatment with inferior
alveolar block. In the robot group, distraction and tell-show-do techniques were used by the
humanoid robot. The robot used in experiments is NAO, manufactured by Softbank Robotics. NAO
is a 58-cm tall robot allowing it to perform the targeted motor tasks. The robot was
programmed to perform the same series of instructions for every patient to guarantee that all
children had the same experience with the robot. The movements of the robot can be controlled
wirelessly from a computer by using Choregraphe software. The investigators prepared the
transactions to let the operator run the corresponding commands for each period of the
treatment in real time to create sequences of behaviours. After each task is defined
individually, it is assigned to a keyboard event. Some combinations of robot movements are
achieved by pressing a single key. With this keyboard interface, the learning time of the
operator has been minimized. At the same time, the effort to control the robot has been
simplified and mistakes have been reduced.
Anxiety status: A series of questionnaires measuring anxiety were administered to each child,
before treatment and after treatment. Facial Image Scale (FIS) is a commonly used scale to
determine the dental anxiety levels of children. Children were asked to point at FIS before
treatment. It consists five faces numbered from 1 to 5 and ranging between "very happy" and
"very unhappy". Each child is asked to point to the face that they feel most closely,
according to their feelings at that moment. The questionnaire was repeated after treatment.
The Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) is used in the assessment of
dental anxiety in children. It consists of 15 questions. Children are asked to give scores
from 1 (not afraid) to 5 (very afraid) for each question. The total score is between 15 and
75 points. Children with CFSS-DS ≥38 were defined as dentally anxious. After the dental
intervention, the children were asked would participants like to see the NAO again in their
next appointment, who participated in robot group.
Behaviour assessment: Frankl's Behaviour Rating Scale (FBRS) were used by the dentist to
assess each children's behaviour. The child's behaviour is classified by one of the
following: definitely negative, negative, positive and definitely positive. Child's behaviour
was evaluated at his/her first visit. Children with FBRS score 1 were excluded from the
study. FBRS was repeated at the end of the treatment session.
Physiologic monitoring:
Pulse oximeter were used to measure physiological pulse rate (bpm) before, during and after
treatment. Saliva was collected using the 'spitting method'. Each subject rinsed their mouth
with water to reduce contamination of saliva with food debris and waited 5 minutes prior to
sampling. Whole mouth saliva from the oral cavity was collected by asking the subjects to sit
comfortably in an upright position and drop down their heads, let the saliva run naturally to
the front of mouth without stimulating flow by oro-facial movements. Saliva that accumulates
in the floor of mouth was expectorated into a graduated a polypropylene test tube every 30 s,
for a total of 2 min. The amount of collected saliva in mL divided by the duration of the
collection period, yielding ml/min was recorded as the mean salivary flow rate. Saliva
samples were collected at three time points as follows: First saliva samples of children were
collected 5 min before the dental intervention (pre-5, measuring the stress of being at the
clinic). The patients then underwent dental procedures which lasted around 30 minutes. Right
after dental care and after 10 minutes of resting (post-10), two new saliva samples were
collected. Collection of at least 1 ml was required. After collection, the unprocessed
samples were stored at -20°C until they were analyzed.
