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Clinical Trials/NCT03497312
NCT03497312
Unknown
Not Applicable

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)

Cairo University0 sites14 target enrollmentDecember 15, 2018
ConditionsQuality of Life

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Cairo University
Enrollment
14
Primary Endpoint
Oral health related quality of life (OHRQOL)
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2018
End Date
June 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Duha Mohammed abdelhameed

Doctor Duha Mohammed Abdelhameed pedodontist principle investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Age range 5 to 14 years.
  • Diagnosed with physical, mental, or sensory disability (separately or combined).
  • 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

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

Outcomes

Primary Outcomes

Oral health related quality of life (OHRQOL)

Time Frame: at baseline and 6 month

Oral health related quality of life (OHRQOL) will be measured by two validated questioner which are : Parental-Caregivers Perceptions Questionnaire (P-CPQ) and family impact scale(FIS). the unit of measurement is likert scale

Secondary Outcomes

  • Body mass(at baseline and 6 month)

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