Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000255785
Ethics application status
Approved
Date submitted
22/02/2013
Date registered
5/03/2013
Date last updated
5/03/2013
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
nil
Universal Trial Number (UTN)
U1111-1139-7217
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

Intervention/exposure
Study type
Interventional
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
Rehabilitation
Comparator / control treatment
no treatment. The patients will serve as their own control.
Control group
Uncontrolled

Outcomes
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
nil
Timepoint [1] 301404 0
nil

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA health status 3 or more
Disabled children

Study design
Purpose of the study
Treatment
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
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4881 0
Saudi Arabia
State/province [1] 4881 0
Riyadh

Funding & Sponsors
Funding source category [1] 286789 0
Self funded/Unfunded
Name [1] 286789 0
nil
Country [1] 286789 0
Primary sponsor type
University
Name
Riyadh Colleges of Dentistry and Pharmacy
Address
Olaya St., Ministry of Interior Avenue
Riyadh 11596, Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 285576 0
None
Name [1] 285576 0
Address [1] 285576 0
Country [1] 285576 0

Ethics approval
Ethics application status
Approved
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
13/10/2012
Approval date [1] 288856 0
13/10/2012
Ethics approval number [1] 288856 0
FRP/2012/7

Summary
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

Contacts
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
+966564181589
Fax 38098 0
Email 38098 0
[email protected]
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
+966564181589
Fax 38099 0
Email 38099 0
[email protected]
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
+966564181589
Fax 38100 0
Email 38100 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.