OHRQoL and and Parental Perception in a Group of Children and Adolescents With Down Syndrome: A Cross

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04394221
Collaborator
(none)
194
7

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate Oral Health related quality of life of children and adolescents with down syndrome and Parental Perception, knowledge and Attitude on oral health conditions of children and adolescents with down syndrome

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Oral disease and conditions can undermine self-image and self-esteem , dis-courage normal social interaction, and cause other health problems and lead to chronic stress and depression , They may also interfere with vital-functions such as breathing , food selection eating, swallowing and speaking, and with activities of daily living such as work, school, and family interactions .

    Oral Health Related Quality of Life captures the aim of new prospective and defined as a multidimensional construct that reflects people's comfort when eating, sleeping and engaging in social inter-action, their self-esteem and their satisfaction with respect to their oral health .

    Down syndrome (DS) is the most common neuro-developmental disorder of known genetic origin, arising from an extra copy of chromosome 21.

    Children and adolescents with down syndrome present particular characteristics that may have a negative impact on their oral health and function. Protruding large tongue and facial muscle hypotonicity impairing speaking and chewing abilities. Bruxism, respiratory problems and mouth breathing are common among them.

    Periodontal disease is the most significant oral health problem in people with Down syndrome due immunological deficiency, poor masticatory function and poor oral hygiene .

    Another common oral manifestation associated with the syndrome is malocclusion. In this regard, mandibular protrusion, anterior open bite, and posterior crossbite have been reported as prevalent outcomes among DS individuals .

    It has been shown that the impact of oral disease on Oral Health Related Quality Of Life of children with disabilities can be used in health service planning and priority setting.

    Studies have recommended that people with a negative oral condition should receive treatment first , Hence this vulnerable group of children needs to be prioritized in the planning of health services and oral health care programs

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    194 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Oral Health Related Quality Of Life and Parental Perception in a Group of Children and Adolescents With Down Syndrome: A Cross Sectional Study
    Anticipated Study Start Date :
    Mar 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2021
    Anticipated Study Completion Date :
    Oct 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. oral health related quality of life of children with down syndrome [one week]

      oral health related quality of life of children with down syndrome will be measured by using Brazilian version of the Oral Health Scale for People with Down syndrome by using scoring system Scoring system Not at all =0 A little=1 Quite a lot =2 Very much =3 the minimum value is 0 the maximum value is 3 and higher scores mean a worse outcome

    Secondary Outcome Measures

    1. Parental perception (knowledge and Attitude on oral health conditions) of children and adolescents with Down syndrome [one week]

      Parental perception (knowledge and Attitude on oral health conditions) of children and adolescents with Down syndrome will be mesured and known by using Brazilian version of the Oral Health Scale for People with Down syndrome by using scoring system Scoring system Not at all =0 A little=1 Quite a lot =2 Very much =3 the minimum value is 0 the maximum value is 3 and higher scores mean a worse outcome in addition to using mcq questions from oral health questionnaire for parental knowledge and Attitude on their children oral health with down syndrome by using simple MCQ questions and the results will be presented in percentage.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 14 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Parents of children and adolescent diagnosed with Down syndrome who agree to participate in the study.

    • Children and adolescents with Down syndrome aged from 6 to 14 years.

    • Both genders.

    Exclusion Criteria:

    -Children/adolescents with multiple disabilities

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Amr Ahmed Essam Ahmed Ali, principal investigator Amr Ahmed Essam Ahmed, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04394221
    Other Study ID Numbers:
    • OHRQoL in down syndrome
    First Posted:
    May 19, 2020
    Last Update Posted:
    Jan 26, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2021