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Clinical Trials/NCT05146271
NCT05146271
Unknown
Not Applicable

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

Cairo University0 sites21 target enrollmentNovember 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Dentistry
Sponsor
Cairo University
Enrollment
21
Primary Endpoint
assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .
Last Updated
4 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 down syndrome .

Detailed 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).

Registry
clinicaltrials.gov
Start Date
November 30, 2021
End Date
September 30, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

mmohamed ramadan mohamed ahmed

Cairo university

Cairo University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .

Time Frame: Baseline

assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .

Secondary Outcomes

  • Change in family conflict scale(Baseline)

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