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

Quality of Life Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03497312
• Other study ID #: OHRQOL in SHCNC
• Status: Not yet recruiting
• Start date: December 15, 2018
• Est. completion date: June 2019

Study information

• Verified date: June 2018
• Source: Cairo University
• Contact: DUHA M ABDELHAMEED, MASTER
• Phone: 00201112096880
• Email: duha.hameed.dh[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: June 2019
• Est. primary completion date: May 2019
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life

Intervention

Procedure:
• full mouth rehabilitation
full mouth rehabilitation under general anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral health related quality of life (OHRQOL)	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	at baseline and 6 month
Secondary	Body mass	Body mass will be measure by body mass index,weight and height will be combined to report BMI in kg/m^2	at baseline and 6 month