Efficacy of Film Modelling in Paediatric Dentistry

Dental Anxiety Clinical Trial

Official title:

The Effect of Filmed Modelling on the Anxious and Cooperative Behaviour of 4-6 Years Old Children During Dental Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908127
• Other study ID #: 1382
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: December 17, 2013
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: December 2013
• Source: Zahedan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Cooperative Behaviour
• Dental Anxiety

Intervention

Behavioral:
• tell- show- do
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.
• film modelling
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. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.

Drug:
• injection of local anesthesia solution
A topical anesthesia and injection of local anesthesia solution using mandibular alveolar nerve block technique was performed by the dentist

Procedure:
• occlusal cavity preparation
the occlusal cavity was prepared for pulpotomy and restoration of the teeth

Locations

Country	Name	City	State
Iran, Islamic Republic of	Zahedan Dental School	Zahedan

Sponsors (1)

Lead Sponsor	Collaborator
Zahedan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behaviors of Children	A video-camera was focused started to record child's behavior. The recorded video tapes were independently evaluated by 2 paediatric dentists who were blind to the grouping of the children. Children's anxiety reactions and cooperative behaviours were scored based on venham scale and Frankle Index ,respectively. quantification was performed at the injection of local anaesthesia and at the beginning of the tooth preparation. An average of both two time points scoring was used.; Table 1: Venham 6-point Index 0 = Relaxed: 1 = Uneasy: 2 = Tense: 3 = Reluctant: 4 = Interference: 5 = Out of contact; Table 2: Frankle 4-point Index; 1:Definitely Negative ( uncooperative,Refusal of treatment ) , 2:Negative ( some evidence of negative attitude but not pronounced) , 3:Positive ( Acceptance of treatment, at times cautious) , 4:Definitely Positive( Good rapport with the dentist)	participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks	No
Secondary	Index of Heart Rate	The heart rate of children was measured before the injection of local anesthesia solution to save a baseline data and it was also measured after the injection to assess the effect of this dental stress.	before and after the injection of local anesthesia solution	No