Child Dental AnxietyNCT06437249
Children's Dental Anxiety in Relation to Parental Dental Anxiety, Child's Age and Gender and Caries Experience
An observational study of Child Dental Anxiety, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Dental Anxiety
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2024to Feb 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 1. Gender: Male and Female. 2. 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.
Who may be able to join
- Children range in age from 6-8 years old.
- First dental visit.
- Accompanied by their parents.
- Both male and female included.
Who cannot join
- Children with Physical or mental disabilities.
- Children who refuse to participate.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University
Cairo, Almanial, Egypt
Rasha l Adel, PHD, 00201111511145, rasha.adel@dentistry.cu.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Child Dental Anxiety
- Keywords
- Parental dental anxiety, Child dental anxiety
What is being measured
The primary outcome is the main question the study is designed to answer.
Child dental anxiety
Using Abeer children dental anxiety SCALE Questionnaire Score score 1 happy 2 Ok 3 Scared
Measured: Two months
Level of anxiety
record Heart rate number using fingertip pulse oximeter
Measured: Two months
Caries experience
Using dental caries indices ( Decayed Missed Filling and Decayed Exposed to extraction Filling ) in mixed dentition
Measured: Two months
Secondary outcomes (1)
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
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Child Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghadeer Jaafar Ali Jawad, Cairo University
- Investigators
- Ola Mustafa, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437249
- Sponsor's protocol ID
- children dental anxiety
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 25187737Corah 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.
PubMed 31377Al-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.
PubMed 23265158Aditya 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.
PubMed 34632153
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Dental Anxiety in Relation to Parental Dental Anxiety, Child's Age and Gender and Caries Experience (Cross Sectional Study)
- ClinicalTrials.gov ID
- NCT06437249
- Acronym / sponsor ID
- children dental anxiety
- Conditions
- Child Dental Anxiety
- Keywords
- Parental dental anxiety, Child dental anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, \&gt;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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 1. Gender: Male and Female. 2. 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.
Key inclusion criteria (4 listed)
- Children range in age from 6-8 years old.
- First dental visit.
- Accompanied by their parents.
- Both male and female included.
Key exclusion criteria (2 listed)
- Children with Physical or mental disabilities.
- Children who refuse to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child dental anxiety
Time frame: Two months
Using Abeer children dental anxiety SCALE Questionnaire Score score 1 happy 2 Ok 3 Scared
Level of anxiety
Time frame: Two months
record Heart rate number using fingertip pulse oximeter
Caries experience
Time frame: Two months
Using dental caries indices ( Decayed Missed Filling and Decayed Exposed to extraction Filling ) in mixed dentition
1 secondary outcome
Parental dental anxiety
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Results publication: PubMed 25187737Coric 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.
- Results publication: PubMed 31377Corah 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.
- Results publication: PubMed 23265158Al-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.
- Results publication: PubMed 34632153Aditya 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola Mustafa, professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Dental Anxiety, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghadeer Jawad, Master (00201220262599 ext. +97333323874, ghadeerja08558@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child dental anxiety (time frame: Two months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06437249, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.