NCT05758974

Brief Summary

What are the possible postoperative complications that may occur for children following dental treatment under general anaesthesia and is there a correlation between those complications and type of dental treatment done?

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
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

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

January 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2024

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

January 20, 2023

Last Update Submit

February 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    pain would be assessed through the faces pain scale- revised this scale is self-report measure of pain intensity for children. These six faces expression show how much something can hurt, face 1 take score 0 no pain as minimum limit, face 2 take score 2, face 3 take score 4, face 4 take score 6, face 5 take score 8, face 6 take score 10 that the maximum limit "Very much pain."

    Baseline

Secondary Outcomes (2)

  • Fever

    Baseline

  • Weariness and drowsiness

    Baseline

Interventions

Extraction, pulp therapy or both

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children will be selected from general anaesthesia unit of Pediatric Dentistry Department, Faculty of Dentistry, Cairo University aged from 3-6 years according to the eligibility criteria.

You may qualify if:

  • Children with age range from 3 to 6 years old .
  • Children affected by dental caries in more than 4 primary teeth.
  • Uncooperative child indicated for treatment under G.A
  • Classified by American Society of Anaesthesiologists Physical Status as Class 1
  • Parents accepted to participate and willing to sign an informed consent.

You may not qualify if:

  • \) The children whose guardians or caregivers have a problem in communicating with the medical staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Deng XY, Zhang YH, Zou J, Zhang Q. [Investigation of postoperative complications in children after dental therapy under general anesthesia]. Hua Xi Kou Qiang Yi Xue Za Zhi. 2020 Jun 1;38(3):284-289. doi: 10.7518/hxkq.2020.03.010. Chinese.

    PMID: 32573136BACKGROUND

MeSH Terms

Interventions

Dental Care

Intervention Hierarchy (Ancestors)

DentistryDental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

sawsan Ah Ebrahim, master

CONTACT

ola mo omar, professor doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator in ministry of health,the health unit in Ibn betk fifth district in 6 October

Study Record Dates

First Submitted

January 20, 2023

First Posted

March 8, 2023

Study Start

September 20, 2023

Primary Completion

September 20, 2024

Study Completion

November 12, 2024

Last Updated

March 8, 2023

Record last verified: 2023-02