NCT03739567

Brief Summary

the purpose of this study is monitoring Postoperative pain in Children Aged from 3 to 5 years following Full mouth Dental Rehabilitation under General Anesthesia

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

March 5, 2019

Status Verified

November 1, 2018

Enrollment Period

Same day

First QC Date

November 7, 2018

Last Update Submit

March 2, 2019

Conditions

Post-operative Pain

Keywords

General anesthesia, clinical manifestations. .

Outcome Measures

Primary Outcomes (1)

  • Dental Discomfort Questionnaire

    Numerical Rating Pain Scale (Outcome measuring device)

    3 monthes

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All children attending the outpatients' clinic of pediatric Dentistry and Public Health Faculty of Dentistry Cairo University-Egypt in the period of three months. (With average 30 patients in week ).

You may qualify if:

  • Egyptian dental children undergoing full mouth dental rehabilitation under general anesthesia (3-5 years old )
  • Children selected from pediatric dentistry and dental public health department Faculty of dentistry Cairo University
  • Children with no developmental delay.
  • Children with normal physical status.
  • Parents who can be communicated well

You may not qualify if:

  • Parents refusing participation in the study.
  • Parents who cannot be communicated well
  • Children with developmental abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Amr ezzat, professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

marwa mostafa ahmed, B.D.S.

CONTACT

01003572429marwa.mostafa@dentistry.cu.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student in Cairo university

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 14, 2018

Study Start

March 1, 2019

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

March 5, 2019

Record last verified: 2018-11