Skip to content

Efficacy of Film Modelling in Paediatric Dentistry

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01908127
Enrollment
50
Registered
2013-07-25
Start date
2010-09-30
Completion date
2011-04-30
Last updated
2014-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cooperative Behaviour, Dental Anxiety

Keywords

film modelling, dental anxiety, cooperative behaviour, children

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.

Interventions

BEHAVIORALtell- 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.

BEHAVIORALfilm 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.

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

PROCEDUREocclusal cavity preparation

the occlusal cavity was prepared for pulpotomy and restoration of the teeth

Sponsors

Zahedan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Behaviors of Childrenparticipants followed for the duration of examination and treatment appointment, an expected average of 3 weeksA 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)

Secondary

MeasureTime frameDescription
Index of Heart Ratebefore and after the injection of local anesthesia solutionThe 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.

Countries

Iran

Participant flow

Recruitment details

September 2010- December 2010 paediatric clinic of dental school, Zahedan University of Medical Sciences

Pre-assignment details

The parents of four the enrolled children declined the participation in the study

Participants by arm

ArmCount
Tell- Show- do Procedure
Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room. In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed.
23
Film Modelling
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. The child in the film was cooperative and was reinforced by a reward at the end of the procedure. In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed.
23
Total46

Baseline characteristics

CharacteristicFilm ModellingTell- Show- do ProcedureTotal
Age, Categorical
<=18 years
23 Participants23 Participants46 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous5 years
STANDARD_DEVIATION 1.17
4.9 years
STANDARD_DEVIATION 1.17
4.95 years
STANDARD_DEVIATION 1.17
Region of Enrollment
Iran, Islamic Republic of
23 participants23 participants46 participants
Sex: Female, Male
Female
14 Participants10 Participants24 Participants
Sex: Female, Male
Male
9 Participants13 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 220 / 23
serious
Total, serious adverse events
0 / 220 / 23

Outcome results

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)

Time frame: participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Tell- Show- do ProcedureBehaviors of Childrencooperative behaviour quantification2.95 units on a scaleStandard Deviation 0.64
Tell- Show- do ProcedureBehaviors of Childrenanxious behaviour quantification0.97 units on a scaleStandard Deviation 0.73
Film ModellingBehaviors of Childrenanxious behaviour quantification1.09 units on a scaleStandard Deviation 0.99
Film ModellingBehaviors of Childrencooperative behaviour quantification2.98 units on a scaleStandard Deviation 0.67
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.

Time frame: before and after the injection of local anesthesia solution

ArmMeasureGroupValue (MEAN)Dispersion
Tell- Show- do ProcedureIndex of Heart Ratebaseline heart rate99.27 beat per MinStandard Deviation 9.17
Tell- Show- do ProcedureIndex of Heart Rateheart rate after the injection110.40 beat per MinStandard Deviation 10.86
Film ModellingIndex of Heart Ratebaseline heart rate102.73 beat per MinStandard Deviation 12.37
Film ModellingIndex of Heart Rateheart rate after the injection113 beat per MinStandard Deviation 13.86

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026