NCT05127655

Brief Summary

To assess Oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children below 5 years

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
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Status
unknown

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

November 9, 2018

Completed
3 years until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

November 19, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

November 9, 2018

Last Update Submit

November 8, 2021

Conditions

Quality of Life

Keywords

Rehabilitationfull mouth rehabilitationQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Oral health related quality of life (OHRQOL)

    Oral health related quality of life (OHRQOL) will be measured by validated questionnaire which is : Early Childhood Oral Health Impact Scale (ECOHIS) . the unit of measurement is likert scale.

    change from baseline oral health related quality of life at 6 months

Secondary Outcomes (1)

  • Body mass index

    change of baseline body mass at 6 months

Interventions

full mouth rehabilitationPROCEDURE

full mouth rehabilitation under general anesthesia

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Caregivers paired with their children attending Pediatric Dentistry and Dental Public Health department, faculty of dentistry, Cairo University Egypt

You may qualify if:

  • Age range 2 to 5 years .
  • Children with untreated early childhood caries .
  • Children who will undergo dental treatment under general anesthesia.

You may not qualify if:

  • Participation in any other concurrent clinical trials.
  • The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
  • Children with special healthcare needs.
  • Children whose parents had no home or mobile phone to enable postoperative contact.
  • Parent that will not sign the consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Fatima Korany, PHD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

eyman sh mokhtar, master

CONTACT

00201114540003emanmokhtar129@yahoo.com

Fatima Korany, PHD

CONTACT

+201006753265fatmadent@hotmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Eyman sheikh eldin mokhtar pedodontist principle investigator

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 19, 2021

Study Start

February 1, 2022

Primary Completion

February 1, 2023

Study Completion

May 1, 2023

Last Updated

November 19, 2021

Record last verified: 2021-10