NCT05146271

Brief Summary

To assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

December 6, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

November 23, 2021

Last Update Submit

November 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .

    assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .

    Baseline

Secondary Outcomes (1)

  • Change in family conflict scale

    Baseline

Interventions

Complete mouth rehabilitation under general anesthesia in a group of Egyptian children with Down syndrome

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Group of Egyptian Children with Down Syndrome

You may not qualify if:

  • Children whose parents had no home or mobile phone to enable post-operative contact.
  • Parent that will not sign the consent.
  • Children whose parents had no home or mobile phone to enable post-operative contact.
  • Parent that will not sign the consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mohamed Ramadan, Bachalor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cairo university

Study Record Dates

First Submitted

November 23, 2021

First Posted

December 6, 2021

Study Start

November 30, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

December 6, 2021

Record last verified: 2021-11