NCT03877874

Brief Summary

The impact of Anti- Asthmatic medications on salivary pH and dental caries pattern in a Group of Egyptian Children with Bronchial Asthma.

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
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 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

March 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
2.3 years until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

March 12, 2019

Last Update Submit

January 28, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • pH of Saliva

    Digital pH electrode meter

    1year

Secondary Outcomes (1)

  • pattern of Dental caries

    1year

Other Outcomes (1)

  • Drug composition(pH and total sugar content)

    2 minutes

Study Arms (2)

Asthmatic children

* Aironyl syrup(Terbutaline sulfate ................. 1.5mg) 0.075-0.29 mg/ kg body weight 3 times daily * Apidone syrup(Dexamethone) (0.02 to 0.3 mg per kilogram (kg) of body weight per day, divided and taken 3 or 4 times a day).

Drug: Aironyl syrup(Terbutaline sulfate) + Epidrone syrup(Dexamethone)

Non-Asthmatic children

no intervention

Interventions

Aironyl syrup(Terbutaline sulfate ................. 1.5mg) 0.075-0.29 mg/ kg body weight 3 times daily Apidone syrup(Dexamethone) (0.02 to 0.3 mg per kilogram (kg) of body weight per day, divided and taken 3 or 4 times a day)

Asthmatic children

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

All patients presented to the Asthma and Allergy Outpatients Clinic of Abu El-Reesh Japanese hospital for kids will be included in the study according to the following criteria. -Control group: All patients attending the pediatric dentistry department of faculty of dentistry of Cairo University will be included in the study according to the following criteria.

You may qualify if:

  • \- Children aged 6-12 years old diagnosed with Bronchial asthma (Mixed dentition stage).
  • Control group : a matched group aged 6-12 years old
  • Patients taking regular medications for the treatment of Bronchial asthma at least for 1 year back
  • Both male and female patients will be included.

You may not qualify if:

  • No other systemic Diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 18, 2019

Study Start

July 1, 2021

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

February 1, 2021

Record last verified: 2021-01