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

March 31, 2023 updated by: Amr Ahmed Essam Ahmed Ali, Cairo University

Oral Health Related Quality of Life and Parental Perception in A Group of Children and Adolescents With Down Syndrome: A Cross-Sectional Study

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

194

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Facult

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 14 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children and adolescents with down syndrome present particular characteristics that may have a negative impact on their oral health and function such as Protruding large tongue , 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

Description

Inclusion Criteria:

  • Parents of children and adolescents diagnosed with Down syndrome who agree to participate in the study.
  • Children and adolescents with Down syndrome aged from 4 to 14 years.
  • Both genders.

Exclusion Criteria:

-Children/adolescents with multiple disabilities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oral health related quality of life of children with down syndrome
Time Frame: 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
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental perception (knowledge and Attitude on oral health conditions) of children and adolescents with Down syndrome
Time Frame: 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.
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHRQoL in down syndrome

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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