Clinical trial NCT01908127: Efficacy of Film Modelling in Paediatric Dentistry
Official title: The Effect of Filmed Modelling on the Anxious and Cooperative Behaviour of 4-6 Years Old Children During Dental Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cooperative Behaviour
Dental Anxiety
Keywords: film modelling
dental anxiety
cooperative behaviour
children
Lead sponsor: Zahedan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to evaluate the effect of Filmed modelling in comparison with commonly used Tell-Show-Do technique on the anxious and cooperative behaviour of 4-6 years old children during dental practice.

Detailed description: This randomized clinical trial study was approved by ethics committee of Zahedan University of Medical Sciences and conducted in pediatric clinic of Zahedan dental school in 2010.

Among the patients referred to the clinic, forty six children aged 4-6 years (±2 months) were selected according to the inclusion criteria. They had caries lesion in one of the primary mandibular molars needed the pulpotomy and restoration treatment. It was confirmed that they have no previous experience of hospitalization and dental visit. The children with systemic diseases and developmental disorders were excluded from the study. The examination was completed and the necessary radiographies were prescribed.

Each child's parent was asked to complete the informed consent and a questionnaire gathering demographic characteristics of the child and family. Then, the child was enrolled in one of the study groups based on simple random sampling model as follow:

Group I (Tell- Show- Do Group): Children came in the operation room. Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant to increase their familiarity with dental procedures. The duration of the appointment was about 20 minutes and constant for all children. At the end of the first visit, the child was rewarded and the date of the second treatment visit was set for one week later.

In the second session, the child was entered the operating room alone. A video-camera located on the top of the dental unit light pole under a covering cloth was focused on the child's head and hands and started to record child's behavior.

The required injection including a mandibular alveolar nerve block technique was performed by the dentist. The heart beat rate of each child was recorded manually before and following the injection by the dentist. Then, the occlusal cavity was prepared for pulpotomy and restoration of the teeth. The treatment protocol was the same for all the participants.

In all children, parameters such as the attending dentist, his assistant, the working environment, time and duration (30 minutes for each child) of work, and the type of dialogues were all the same. Care was taken to make sure that the children were not tired, hungry, or did not have a common cold.

Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes which was cooperative and reinforced by a reward at the end of the procedure. The produced film had been approved by 3 pediatric dentists.

The second treatment session was set for one week later. Dental procedures, measurement of the heart rate and recording of the behaviors were all performed as in Group I.

The recorded video tapes of all children were independently evaluated by 2 pediatric dentists who were blind to the grouping of the children. Children's anxiety reactions and cooperative behaviors were scored based on Venham Scale and Frankle Index, respectively .The viewers were asked to rate the child's responses in two stages: At the injection of local anesthesia and at the beginning of the tooth preparation.

Statistical analysis Mean of heart rate measurements and behavioral ratings were used for statistical analyses. Data analysis was performed applying t-test method in package of statistical software (SPSS- 15). All statistical references were made at 0.05.

Eligibility criteria: Inclusion Criteria:

* children aged 4-6 years
* caries lesion in one of the primary mandibular molars needs to pulpotomy and restoration treatment.

Exclusion Criteria:

* children with systemic diseases and developmental disorders
* previous experience of hospitalization

Primary outcomes:
measure: Behaviors of Children
timeFrame: participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks
Secondary outcomes:
measure: Index of Heart Rate
timeFrame: before and after the injection of local anesthesia solution
Other outcomes:
Locations:
city: Zahedan
country: Iran, Islamic Republic of
facility: Zahedan Dental School
Study officials:
affiliation: dental school, tehran university of medical sciences
name: mehrsa paryab, Dr
role: PRINCIPAL_INVESTIGATOR
References: