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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06437249
Other study ID # children dental anxiety
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date February 2025

Study information

Verified date May 2024
Source Cairo University
Contact Ghadeer Jawad, Master
Phone 00201220262599
Email ghadeerja08558@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

1. Soft copies of the Abeer children dental anxiety SCALE (ACDAS) Questionnaire and Corah Dental Anxiety Scale (CDAS) Questionnaire. 2. The child's age and gender will be recorded first. 3. Level of anxiety will be recorded by using Heart rate using fingertip pulse oximeter. 4. Dental caries experiences will record by using Dental caries indices (DMF and def) 5. 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) 6. 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). 7. Results will be analyzed by the statistician. 8. Data handling will be supervised by the supervisors.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 74
Est. completion date February 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 8 Years
Eligibility Inclusion Criteria: 1. Children range in age from 6-8 years old. 2. First dental visit. 3. Accompanied by their parents. 4. Both male and female included. Exclusion Criteria: 1. Children with Physical or mental disabilities. 2. Children who refuse to participate.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Cairo University Cairo Almanial

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Child dental anxiety Using Abeer children dental anxiety SCALE Questionnaire Score score 1 happy 2 Ok 3 Scared Two months
Primary Level of anxiety record Heart rate number using fingertip pulse oximeter Two months
Primary Caries experience Using dental caries indices ( Decayed Missed Filling and Decayed Exposed to extraction Filling ) in mixed dentition Two months
Secondary Parental dental anxiety Using Corah Dental Anxiety Scale Questionnaire Score a = 1, b = 2, c = 3, d = 4, e = 5 Total possible = 20
< 9 = mild
9 - 12 = moderate anxiety
13 - 14 = high anxiety
15 - 20 = severe anxiety (or phobia) higher score means worse
Two months
See also
  Status Clinical Trial Phase
Recruiting NCT04186689 - Relationship Between Food Insecurity and Child Dental Anxiety