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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04183777
Other study ID # Cairo university ,Egypt
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date March 1, 2021

Study information

Verified date December 2019
Source Cairo University
Contact aya elsahouri, bachelor
Phone 00201062141215
Email drayaelsanhory@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

to asses the age, reasons, oral health status and dental treatment needs of children in their first dental visit.


Description:

We are going to provide each parent or guardian whose children fulfilling the inclusion criteria attending to Department of Paediatrics Dentistry at Cairo University to fulfil questionnaire which include multiple MCQ questions. The state of oral health and dental treatment needs will be assessed based on clinical examination, according to recommendations of the World Health Organization. The total number of teeth and number of teeth affected by decay (d, D) in every child will be recorded. The intensity of caries will be estimated based on the average dmf/DMF number, i.e. caries intensity index.

The dental treatment needs of each child will be assessed based on the following categories:

1. None: no restorative treatment required.

2. Simple: preventive treatment required, such as scaling and brushing, oral hygiene instruction (OHI), application of topical fluoride and fissure sealant.

3. Moderate: one or more of teeth require one or two surface restoration.

4. Complex: one or more teeth require three or four surface restoration / stainless steel crown, endodontic therapy and crown, and /or extraction(7) .

Reasons for first dental visit will be categories as :

a. Adaptive visit dental check-up preventive purpose. b. Tooth pain. c. Emergency case (tooth injury, abscess, infection). d. Decay noted by parent.

e. Any Other. We will explain to the parents and legal guardians the aim of the study without any guiding to prevent any information bias which may occur. The questionnaire will be given before the treatment and will be collected after it. Any children whose records will include missing information will be excluded from the study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date March 1, 2021
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 12 Years
Eligibility Inclusion Criteria:

- Children with Primary and mixed dentition.

- Children visiting the dentist for the first time (first dental visit

Exclusion Criteria:

- Children with systemic diseases or physical and mental problem.

- Children whose parents refuse participation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Aya Abdelmawgoud Elsanhouri El-Sheikh Zayed City Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary reasons for the first dental visit. There are different reasons for the first dental visit these reasons may be due to a- Adaptive visit dental check-up preventive purpose. b. Tooth pain. c. Emergency case (tooth injury, abscess, infection). d. Decay noted by parent.
e. Any Other.
Caregiver will be asked to fill a questionnaire include multiple reasons. The parents or Guardian select the most chief complain for coming to the first dental visit. And after selection the most common reason will determine.
1 year
Secondary age Caregiver will be asked to fill a questionnaire include multiple age. The parents or Guardian select the most optimal age for the first dental visit from their point of view . 1 years
Secondary oral health The state of oral health will be assessed based on clinical examination, according to recommendations of the World Health Organization. The total number of teeth and number of teeth affected by decay (d, D) in every child will be recorded. The intensity of caries will be estimated based on the average dmf/DMF number, i.e. caries intensity index. 1 years
Secondary dental treatment needs Dental treatment needs will be assessed based on clinical examination, according to recommendations of the World Health Organization.
The dental treatment needs of each child will be assessed based on the following categories:
None: no restorative treatment required.
Simple: preventive treatment required, such as scaling and brushing, oral hygiene instruction (OHI), application of topical fluoride and fissure sealant.
Moderate: one or more of teeth require one or two surface restoration. D-Complex: one or more teeth require three or four surface restoration / stainless steel crown, endodontic therapy and crown, and /or extraction.
1 years
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