Clinical trial NCT03497312: Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under GA
Official title: Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children With Special Health Care Need (A Before and After Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Keywords: Rehabilitation
children with disabilities
general anesthesia
Children with special healthcare need
handicapped children
full mouth rehabilitation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 14
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers paired with their children with special health care needs attending Pediatric Dentistry and Dental Public Health department, faculty of dentistry, Cairo University Egypt, will be screened for diagnosis of their chief complaint. Patients will be enrolled in this study if they are compatible with eligibility criteria.

Brief summary: To assess Oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with special healthcare need.

Detailed description: * The study will be conducted in Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt.
* Demographic variables (caregiver age and gender), socio-economic condition, , medical history, and dental history will be collected from the parent or caregiver. The height and weight of each child will be measured in the same manner to standardize the result and their body mass index will be calculated before and after in follow up period.
* On the day of the GA, parent or caregiver will complete questionnaires about their child's oral state and well-being over the previous 3 months and oral hygiene instructions will be given to the parent.
* The questionnaire will be delivered to the parents/caregivers at baseline and at the 6-month post-operative follow-up visit. Dental examination will be assessed at baseline (pre-operatively) and at 1,3, 6, months post-operative visits.

Eligibility criteria: Inclusion Criteria:

1. Age range 5 to 14 years.
2. Diagnosed with physical, mental, or sensory disability (separately or combined).
3. Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.

Exclusion Criteria:

1. Participation in any other concurrent clinical trials.
2. The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
3. Children whose parents had no home or mobile phone to enable post-operative contact.
4. Parent that will not sign the consent.

Primary outcomes:
measure: Oral health related quality of life (OHRQOL)
timeFrame: at baseline and 6 month
Secondary outcomes:
measure: Body mass
timeFrame: at baseline and 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Sheriene Ezz Eldin, PHD
role: STUDY_DIRECTOR
References:
citation: Baens-Ferrer C, Roseman MM, Dumas HM, Haley SM. Parental perceptions of oral health-related quality of life for children with special needs: impact of oral rehabilitation under general anesthesia. Pediatr Dent. 2005 Mar-Apr;27(2):137-42.
citation: Gaynor WN, Thomson WM. Changes in young children's OHRQoL after dental treatment under general anaesthesia. Int J Paediatr Dent. 2012 Jul;22(4):258-64. doi: 10.1111/j.1365-263X.2011.01190.x. Epub 2011 Oct 17.
citation: Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Measuring parental perceptions of child oral health-related quality of life. J Public Health Dent. 2003 Spring;63(2):67-72. doi: 10.1111/j.1752-7325.2003.tb03477.x.