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Quality of LifeNCT04394221

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

An observational study of Quality of Life and Down Syndrome, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 4 to 14 years
Conditions the study is for
Quality of Life, Down Syndrome, Oral Health
How many people
194 participants
Where
1 siteEgypt
Study dates
15 Apr 2021to 15 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 14 years
  • All sexes
  • Child

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

Who may be able to join

  • 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.

Who cannot join

  • -Children/adolescents with multiple disabilities

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Facult

    Cairo

Other trials in Egypt

About this study

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

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

Read the 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

Medical subject headings
Down Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. oral health related quality of life of children with down syndrome

    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

    Measured: one week

Secondary outcomes (1)

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

    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.

    Measured: one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start15 Apr 2021
  3. Primary completion1 Dec 2021
  4. Study completion15 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04394221
Sponsor's protocol ID
OHRQoL in down syndrome
Status last verified
Mar 2023
First submitted
15 May 2020
Last updated
4 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bennadi D, Reddy CV. Oral health related quality of life. J Int Soc Prev Community Dent. 2013 Jan;3(1):1-6. doi: 10.4103/2231-0762.115700.

    PubMed 24478972

  • Satcher D, Nottingham JH. Revisiting Oral Health in America: A Report of the Surgeon General. Am J Public Health. 2017 May;107(S1):S32-S33. doi: 10.2105/AJPH.2017.303687. No abstract available.

    PubMed 28661821

  • Karmiloff-Smith A, Al-Janabi T, D'Souza H, Groet J, Massand E, Mok K, Startin C, Fisher E, Hardy J, Nizetic D, Tybulewicz V, Strydom A. The importance of understanding individual differences in Down syndrome. F1000Res. 2016 Mar 23;5:F1000 Faculty Rev-389. doi: 10.12688/f1000research.7506.1. eCollection 2016.

    PubMed 27019699

  • Hennequin M, Faulks D, Veyrune JL, Bourdiol P. Significance of oral health in persons with Down syndrome: a literature review. Dev Med Child Neurol. 1999 Apr;41(4):275-83. doi: 10.1017/s0012162299000596. No abstract available.

    PubMed 10355815

  • Kaye PL, Fiske J, Bower EJ, Newton JT, Fenlon M. Views and experiences of parents and siblings of adults with Down Syndrome regarding oral healthcare: a qualitative and quantitative study. Br Dent J. 2005 May 14;198(9):571-8, discussion 559. doi: 10.1038/sj.bdj.4812305.

    PubMed 15895058

  • Allen PF. Assessment of oral health related quality of life. Health Qual Life Outcomes. 2003 Sep 8;1:40. doi: 10.1186/1477-7525-1-40.

    PubMed 14514355

  • Glassman P, Miller CE. Effect of preventive dentistry training program for caregivers in community facilities on caregiver and client behavior and client oral hygiene. N Y State Dent J. 2006 Mar-Apr;72(2):38-46.

    PubMed 16711592

  • Norwood KW Jr, Slayton RL; Council on Children With Disabilities; Section on Oral Health. Oral health care for children with developmental disabilities. Pediatrics. 2013 Mar;131(3):614-9. doi: 10.1542/peds.2012-3650. Epub 2013 Feb 25.

    PubMed 23439896

  • Porovic S, Zukanovic A, Juric H, Dinarevic SM. ORAL HEALTH OF DOWN SYNDROME CHILDREN IN BOSNIA AND HERZEGOVINA. Mater Sociomed. 2016 Oct;28(5):370-372. doi: 10.5455/msm.2016.28.370-372. Epub 2016 Oct 17.

    PubMed 27999487

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and Down Syndrome, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

oral health related quality of life of children with down syndrome (time frame: one week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04394221, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.

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