NCT04394221

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

May 15, 2020

Last Update Submit

March 31, 2023

Conditions

Outcome Measures

Primary Outcomes (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

    one week

Secondary Outcomes (1)

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

    one week

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • Children/adolescents with multiple disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facult

Cairo, Egypt

Location

Related Publications (9)

  • 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.

    PMID: 24478972BACKGROUND
  • 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.

    PMID: 28661821BACKGROUND
  • 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.

    PMID: 27019699BACKGROUND
  • 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.

    PMID: 10355815BACKGROUND
  • 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.

    PMID: 15895058BACKGROUND
  • 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.

    PMID: 14514355BACKGROUND
  • 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.

    PMID: 16711592BACKGROUND
  • 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.

    PMID: 23439896BACKGROUND
  • 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.

    PMID: 27999487BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator Amr Ahmed Essam Ahmed

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 19, 2020

Study Start

April 15, 2021

Primary Completion

December 1, 2021

Study Completion

December 15, 2021

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations