Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under GA

• Conditions: Quality of Life

• Registration Number: NCT03497312
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-13
• Study Start: 2018-12-15
• Primary Completion: 2019-05
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral health related quality of life (OHRQOL)	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 Outcome Measures

Name	Time	Method
Body mass	at baseline and 6 month	Body mass will be measure by body mass index,weight and height will be combined to report BMI in kg/m\^2