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Clinical Trial Summary

The basis of pediatric dentistry is to provide cooperation in children with various behavioral management techniques. The presence or absence of the parent during dental treatments can be used to ensure the child's compliance with the treatment. The aim of this study is to investigate the effect of the presence or absence of the parent on the child's dental anxiety and child's behavior during dental treatment. The secondary aim is to examine the relationship between the child's dental fear and the parent's dental fear. Healthy children between the ages of 4-7, who have no dental experience and need restorative treatment will be included in the study. Participants will be randomly assigned to one of three study groups (Group 1: Parental absence, Group 2: Parent behind a barrier and Group 3: Parental presence). Psychometric and projective tests will be applied to assess child's and parent's dental anxiety at the beginning of the study. At the second appointment scheduled for the operative treatment of decayed primary molar tooth, first the child will be administered topical and local anesthesia, a rubber dam will be placed on the decayed tooth, the caries will be removed with high and low speed rotary instruments and the cavity will be restored with a compomer filling. Children's heart rates and blood oxygen saturation will be measured by a pulse oximeter during treatment in order to evaluate dental anxiety. Children will be videotaped during treatment so that their behaviour can be evaluated later by another researcher. After treatment, psychometric and projective tests used to measure the child's dental anxiety will be re-administered.


Clinical Trial Description

The aim of this clinical study is: - to determine the presence or absence of the parent during the treatment in order to ensure the cooperation of the child during the dental treatment - to investigate the relationship between the parent's dental fear and the child's dental fear 72 healthy children aged 4-7 will be recruited from Ankara Yıldırım Beyazıt University Faculty of Dentistry, Department of Pediatric Dentistry outpatient clinic. Participants who met the inclusion criteria and agreed to participate will be randomly allocated to Group 1 (Parental absence), Group 2 (Parent behind a barrier) or Group 3 (Parental presence). A simple randomization method will be used with opaque sealed envelopes containing "Group 1", "Group 2" or "Group 3" prepared separately for 4 different ages (4, 5, 6 and 7) in the study. Group allocation will be performed by an independent researcher, not involved in the study. "Venham Picture Test" and "The Dental Subscale of the Children's Fear Survey Schedule" questionnaire will be applied to the children before and after the dental treatments. The parent's dental anxiety will be measured with "The Corah Dental Anxiety Scale" and parent's attitude will be measured with "Parental Attitude Scale". During the dental treatments the heart rate and the blood oxygen saturation of each participant will be recorded at 30-second intervals. The mean number of these measurements will be calculated for each of the following processes. 1. Sitting in the dental chair at the beginning of the treatment 2. Administration of topical anesthesia 3. Administration of local anesthesia 4. Caries removal with high-speed rotary instrument 5. Caries removal with low-speed rotary instrument 6. Application of dental matrix 7. Placement of dental filling material 8. Restoration finishing and polishing 9. Sitting in the dental chair at the end of the treatment Video recordings taken during dental treatment will be watched later by a dentist who is blind to the treatment groups and the child's cooperation during treatment will be recorded using the Frankl behavioral scale. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05125731
Study type Interventional
Source Ankara Yildirim Beyazit University
Contact
Status Completed
Phase N/A
Start date October 1, 2021
Completion date April 1, 2022

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