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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Dental Treatment under General Anesthesia on Children’s Health
Scientific title
Effects of Dental Rehabilitation under General Anesthesia on Children’s Oral-Health-Related Quality of Life in Children with Dental Caries
Secondary ID [1] 282016 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries in children 288461 0
Condition category
Condition code
Oral and Gastrointestinal 288806 288806 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Study type
Description of intervention(s) / exposure
A pre- and post-test design will be used in which a questionnaire will be distributed to the child’s parent/caregiver to be completed before dental treatment under GA and another similar questionnaire will be distributed one month after GA. Each questionnaire comprises two global items, 33 P-CPQ items and 14 FIS items. These are scored using 5-point Likert-type response options. A P-CPQ consists of 33 items, measuring oral symptoms (six items), functional limitations (eight items), emotional well-being (nine items), and social well-being (ten items). A FIS scale consists of 14 items, measuring parental/family activity (five items), parental emotions (four items), and family conflict (four items). The scores for both P-CPQ and FIS will be computed and compared as a total and for each subscale.

The intervention includes providing the children affected by dental caries with complete oral rehabilitation, including dental fillings, pulp therapy, and/or extraction. The dental treatment will be provided in the operating room while the child patient under standard general anesthesia. The dental treatment may require up to 3 hours and will be completed in a single session. The treatment will not be repeated.
Intervention code [1] 286590 0
Comparator / control treatment
no treatment. The patients will serve as their own control.
Control group

Primary outcome [1] 288944 0
Dental treatment under GA will have a positive impact on OHRQoL of children and their families, as percieved and reported by the child's parents. The questionnaire will assess parent's perception to child's quality of life after dental treatment and the effects of this improvement, if achieved, on family using a Family Impact Scale.
Timepoint [1] 288944 0
Baseline and after 4-8 weeks of treatment. The assessment will be completed once in each interval (i.e., at baseline before dental treatment and after 4-8 weeks of dental treatment). Dental treatment will be copmleted in one session.
Secondary outcome [1] 301404 0
Timepoint [1] 301404 0

Key inclusion criteria
Healthy children who otherwise have dental caries below the age of 10 in need of dental rehabilitation under general anesthesia
Minimum age
3 Years
Maximum age
10 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
ASA health status 3 or more
Disabled children

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 4881 0
Saudi Arabia
State/province [1] 4881 0

Funding & Sponsors
Funding source category [1] 286789 0
Self funded/Unfunded
Name [1] 286789 0
Address [1] 286789 0
Country [1] 286789 0
Primary sponsor type
Riyadh Colleges of Dentistry and Pharmacy
Olaya St., Ministry of Interior Avenue
Riyadh 11596, Saudi Arabia
Saudi Arabia
Secondary sponsor category [1] 285576 0
Name [1] 285576 0
Address [1] 285576 0
Country [1] 285576 0

Ethics approval
Ethics application status
Ethics committee name [1] 288856 0
Research Center
Ethics committee address [1] 288856 0
Riyadh Colleges of Dentistry and Pharmacy
P.O. Box 84891 Riyadh 11681, Kingdom of Saudi Arabia
Ethics committee country [1] 288856 0
Saudi Arabia
Date submitted for ethics approval [1] 288856 0
Approval date [1] 288856 0
Ethics approval number [1] 288856 0

Brief summary
This is a pre-test/post-test clinical study, utilizing children below the age of 10 years as a study sample. Questionnaires will be provided to children’s parents to assess the effects of dental treatment under GA on children affected with dental caries (teeth decay) and their families.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 38098 0
Dr Ziad Baghdadi
Address 38098 0
P.O. Box 67126
Riyadh 11596, Saudi Arabia
Country 38098 0
Saudi Arabia
Phone 38098 0
Fax 38098 0
Email 38098 0
Contact person for public queries
Name 38099 0
Dr Ziad Baghdadi
Address 38099 0
P.O. Box 67126
Riyadh 11596, Saudi Arabia
Country 38099 0
Saudi Arabia
Phone 38099 0
Fax 38099 0
Email 38099 0
Contact person for scientific queries
Name 38100 0
Dr Ziad Baghdadi
Address 38100 0
P.O. Box 67126
Riyadh 11596, Saudi Arabia
Country 38100 0
Saudi Arabia
Phone 38100 0
Fax 38100 0
Email 38100 0

No information has been provided regarding IPD availability
Summary results
No Results