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 Below 5 Years Old (A Before and After Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05127655
• Other study ID #: OHRQOL in 5 years children
• Status: Not yet recruiting
• Start date: February 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: October 2021
• Source: Cairo University
• Contact: eyman sh mokhtar, master
• Phone: 00201114540003
• Email: emanmokhtar129[@]yahoo.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 below 5 years

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: May 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• Age range 2 to 5 years .
• Children with untreated early childhood caries .
• Children who will undergo dental treatment under general anesthesia.

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 with special healthcare needs.
• Children whose parents had no home or mobile phone to enable postoperative contact.
• 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

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 validated questionnaire which is : Early Childhood Oral Health Impact Scale (ECOHIS) .; the unit of measurement is likert scale.	change from baseline oral health related quality of life at 6 months
Secondary	Body mass index	Children's weights will be measured in kilograms and heights in meters .Body max index (BMI) will be calculated using this formula: BMI = weight (kg) / height (m)² to report BMI in kg/m^2	change of baseline body mass at 6 months