Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT03159793
Status:
UNKNOWN
Last Update Posted:
2018-01-25
First Post:
2017-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Different Modelling Techniques on Child Anxiety (RCT)
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Evaluation of Live Modelling and Filmed Modelling Techniques Versus no Modelling on Child Anxiety During Dental Treatment: A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: