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Clinical Trials/NCT03159793
NCT03159793
Unknown
Not Applicable

Evaluation of Live Modelling and Filmed Modelling Techniques Versus no Modelling on Child Anxiety During Dental Treatment: A Randomized Clinical Trial

Cairo University1 site in 1 country51 target enrollmentDecember 15, 2017
ConditionsAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Cairo University
Enrollment
51
Locations
1
Primary Endpoint
Dental Anxiety [using Facial Image Scale]
Last Updated
8 years ago

Overview

Brief Summary

A huge number of children suffer from anxiety during their dental treatment especially those who did not receive any type of behavior management during their first dental visit. This will result in a more complicated treatment sessions for the children, dentist and the parents. Fear and anxiety control is the key to change the resistant nature of the anxious patients and also allow them to receive the proper treatment they require. From the point of view that there is no difference between the techniques effectiveness, evaluation of two modelling techniques (live modelling and filmed modelling versus no modelling) for children anxious behavior management during the dental treatment will be performed.

Detailed Description

i. Diagnosis: 1. History taking \[personal, medical and dental\]. 2. Clinical examination using mirror and probe. 3. Radiographic examination to make sure that the caries is simple. 4. Preoperative photograph is taken. ii. Interventions to each group 1. Group A: Live modelling technique 1. In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale. 2. A cooperative patient will be the model for the child. 3. In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form of Frankl behavior rating scale is filled. 4. The treatment is performed as follows: i. Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material placement. v. Finishing of the filling. e. The child will be asked to complete a facial image scale 2. Group B: video modelling technique (1) In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale. 1. A recorded film will be shown to the child. 2. In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form of Frankl behavior rating scale is filled. 3. The treatment is performed as follows: i. Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material placement. v. Finishing of the filling. d. The child will be asked to complete a facial image scale. 3. Group C: No modelling 1. In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale. 2. In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form to Frankl behavior rating scale. 3. The treatment is performed as follows: i. Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material places. v. Finishing of the filling. d. The child will be asked to complete a facial image scale.

Registry
clinicaltrials.gov
Start Date
December 15, 2017
End Date
September 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mariam Salah Mohammad Yassin

Principal investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • English articles
  • In vivo study (RCT)
  • Medically free children
  • Age group 5-6 years old

Exclusion Criteria

  • Medically compromised children
  • Adult patients

Outcomes

Primary Outcomes

Dental Anxiety [using Facial Image Scale]

Time Frame: after finishing the procedures in the 2nd dental visit [ after two weeks of allocation]

Secondary Outcomes

  • Oxygen Saturation [using Pulse oximetry](Readings are taken in the 2nd dental visit [after two weeks from allocation])
  • Heart Rate [using Pulse oximetry](Readings are taken in the 2nd dental visit [after two weeks from allocation])
  • Patient Cooperation [usind Frankl rating scale](This is perfomred in the allocation visit , in the 1st dental visit [ after a week from allocation], in the 2nd visit [ after two weeks from allocation])

Study Sites (1)

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