Change in Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children With Down Syndrome

Pediatric Dentistry Clinical Trial

Official title:

Change in Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children With Down Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05146271
• Other study ID #: Change in quality of life
• Status: Not yet recruiting
• Start date: November 30, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2021
• Source: Cairo University
• Contact: Mohamed Ramadan, Bachalor
• Phone: 0201273215905
• Email: mohamedramadan[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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 down syndrome .

Description:

Dental treatment under GA provides a safe approach and has significant positive effects on quality of life for children with down syndrome who cannot accept normal treatment. Oral health related quality of life is measured in relation to how the mouth and teeth affect physical, psychological and social well-being and daily activities such as eating, chewing, swallowing, speaking, playing, learning, happiness, embarrassment, and social interactions (Jabarifar et al., 2009). Jankauskiene et al., 2010 conducted a systematic review concluded that "Oral rehabilitation under GA results in immediate improvement of the children's oral health and physical, emotional and social quality of life. It also has a positive impact on the family". Dental caries is a common condition amongst young children which negatively impacts on their quality of life. children with down syndrome who have an increased risk of developing caries due to various reasons: limited oral healthcare, difficultty in dental services,un stable diet, the high sugar contents in their medications and low salivary secretion(Peerbhay & Titinchi, 2014).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

Inclusion Criteria:

• Inclusion Criteria Age range 1 to 15 years. Diagnosed with down syndrome 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.

Exclusion Criteria:

• Inclusion Criteria Age range 3 to 14 years. Diagnosed with down syndrome 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.

Related Conditions & MeSH terms

• Down Syndrome
• Pediatric Dentistry

Intervention

Procedure:
• Complete mouth rehabilitation under general anesthesia in a group of Egyptian children with Down syndrome
Complete mouth rehabilitation under general anesthesia in a group of Egyptian children with Down syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .	assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .	Baseline
Secondary	Change in family conflict scale	Change in family conflict	Baseline