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OHRQoL in a Group of Children & Adolescent With Down Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04394221
Recruitment Status : Not yet recruiting
First Posted : May 19, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Amr Ahmed Essam Ahmed Ali, Cairo University

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
Quality of Life Down Syndrome Oral Health

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

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Study Type : Observational
Estimated Enrollment : 194 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Oral Health Related Quality Of Life in a Group of Children & Adolescent (6-14y) With Down Syndrome: A Cross Sectional Study
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. oral health related quality of life of children with down syndrome & parental perception [ Time Frame: one week ]
    oral health related quality of life of children with down syndrome & parental perception 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 knowledge and attitude [ Time Frame: one week ]

    Parental knowledge and attitude will be known by 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 such as:

    1. Who is responsible for brushing child's teeth?

      ☐Child himself ☐Nanny & nurse ☐Older sibling ☐Parents

    2. How many times per day do you brush your child's teeth?

      ☐Never ☐Occasionally ☐once/day ☐2times/day ☐3times/day

    3. What do you use to clean your child's teeth?

      ☐Toothbrush ☐water only ☐piece of gauze

    4. do you use toothpaste to clean your child's mouth?

      ☐Yes ☐No

    5. Have you Ever received any information about children's tooth brushing? ☐yes ☐No

    and the results will be presented in percentage.




Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes 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
Criteria

Inclusion Criteria:

  • Parents of children and adolescent diagnosed with down syndrome agree to participate in the study
  • Children/adolescents aged from 6 to 14 years.
  • Both genders.
  • Children/adolescents diagnosed with down syndrome

Exclusion Criteria:

  • Children/adolescents whose parents didn't agree to participate in the study
  • Children/adolescents with multiple disabilities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394221


Contacts
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Contact: Amr Ahmed Essam, BDS 0201005356976 amr_ahmed@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
Publications:

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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    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn