- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06437249
Children's Dental Anxiety in Relation to Parental Dental Anxiety, Child's Age and Gender and Caries Experience
May 30, 2024 updated by: Ghadeer Jaafar Ali Jawad, Cairo University
Children's Dental Anxiety in Relation to Parental Dental Anxiety, Child's Age and Gender and Caries Experience (Cross Sectional Study)
Determine the relation of of Children's dental anxiety to Parental Dental anxiety, child's age and gender and caries experience will be obtained through written questionnaires (ACDAS) and (CDAS) to the child and parents of children aged 6-8 years old in the clinic.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
- Soft copies of the Abeer children dental anxiety SCALE (ACDAS) Questionnaire and Corah Dental Anxiety Scale (CDAS) Questionnaire.
- The child's age and gender will be recorded first.
- Level of anxiety will be recorded by using Heart rate using fingertip pulse oximeter.
- Dental caries experiences will record by using Dental caries indices (DMF and def)
- Child dental anxiety will be evaluated from (ACDAS) Questionnaire: The first part is child self-report part, the operator will be answered by ticking the box that corresponds to child dental anxiety, 1 (happy), 2 (Ok), 3 (Scared). The second part about the cognitive part with five questions: three of them answered with (Yes, No) and the other two questions answered with score, 1 (happy), 2 (Ok), 3 (Scared)
- Parents dental anxiety will be evaluated from (CDAS) Questionnaire. the parents will answer by ticking the answer. The final scores, >9 (Mild anxiety), 9-12 (Moderate anxiety), 13-14 (High anxiety), 15-20 (Sever anxiety).
- Results will be analyzed by the statistician.
- Data handling will be supervised by the supervisors.
Study Type
Observational
Enrollment (Estimated)
74
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ghadeer Jawad, Master
- Phone Number: +97333323874 00201220262599
- Email: ghadeerja08558@gmail.com
Study Locations
-
-
Almanial
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Cairo, Almanial, Egypt, Egypt
- Cairo University
-
Contact:
- Rasha l Adel, PHD
- Phone Number: 00201111511145
- Email: rasha.adel@dentistry.cu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
- Gender: Male and Female.
Age: 6-8 years old
- in Pediatric Clinic in Pediatric Dentistry and Dental Public Health Department-faculty of Dentistry, Cairo University, Egypt.
- parents will be interviewed by the examiner and the questionnaire will be filled.
Description
Inclusion Criteria:
- Children range in age from 6-8 years old.
- First dental visit.
- Accompanied by their parents.
- Both male and female included.
Exclusion Criteria:
- Children with Physical or mental disabilities.
- Children who refuse to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child dental anxiety
Time Frame: Two months
|
Using Abeer children dental anxiety SCALE Questionnaire Score score 1 happy 2 Ok 3 Scared
|
Two months
|
|
Level of anxiety
Time Frame: Two months
|
record Heart rate number using fingertip pulse oximeter
|
Two months
|
|
Caries experience
Time Frame: Two months
|
Using dental caries indices ( Decayed Missed Filling and Decayed Exposed to extraction Filling ) in mixed dentition
|
Two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental dental anxiety
Time Frame: Two months
|
Using Corah Dental Anxiety Scale Questionnaire Score a = 1, b = 2, c = 3, d = 4, e = 5 Total possible = 20
|
Two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ola Mustafa, professor, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Coric A, Banozic A, Klaric M, Vukojevic K, Puljak L. Dental fear and anxiety in older children: an association with parental dental anxiety and effective pain coping strategies. J Pain Res. 2014 Aug 20;7:515-21. doi: 10.2147/JPR.S67692. eCollection 2014.
- Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9. doi: 10.14219/jada.archive.1978.0394.
- Al-Namankany A, Ashley P, Petrie A. The development of a dental anxiety scale with a cognitive component for children and adolescents. Pediatr Dent. 2012 Nov-Dec;34(7):e219-24.
- Aditya PVA, Prasad MG, Nagaradhakrishna A, Raju NS, Babu DN. Comparison of effectiveness of three distraction techniques to allay dental anxiety during inferior alveolar nerve block in children: A randomized controlled clinical trial. Heliyon. 2021 Sep 29;7(9):e08092. doi: 10.1016/j.heliyon.2021.e08092. eCollection 2021 Sep.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
May 21, 2024
First Submitted That Met QC Criteria
May 30, 2024
First Posted (Actual)
May 31, 2024
Study Record Updates
Last Update Posted (Actual)
May 31, 2024
Last Update Submitted That Met QC Criteria
May 30, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- children dental anxiety
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
evaluate the relation between the parental dental anxiety, child age and gender and caries experience on child dental anxiety in a group of Egyptian children.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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