The Impact of Anti- Asthmatic Medications on Salivary pH and Dental Caries Pattern in a Group of Egyptian Children With Bronchial Asthma

The Impact of Anti- Asthmatic Medications on Salivary pH and Dental Caries Pattern in a Group of Egyptian Children With Bronchial Asthma: A Cohort Study

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

Study Overview

• Status: Unknown
• Conditions: pH
• Intervention / Treatment: Drug: Aironyl syrup(Terbutaline sulfate) + Epidrone syrup(Dexamethone)

Detailed Description

Due to lack of published studies about the impact of anti-asthmatic medications on salivary pH and dental caries pattern among the Egyptian children diagnosed with Bronchial Asthma, this study will be conducted to cover this point.

• Study Type: Observational
• Enrollment (Anticipated): 58

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• - 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.

Exclusion Criteria:

• No other systemic Diseases.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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)
Non-Asthmatic children; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pH of Saliva	Digital pH electrode meter	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pattern of Dental caries	DMFs/defs index	1year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug composition(pH and total sugar content)	Digital PH electrode meter	2 minutes

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (ACTUAL): March 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Stomatognathic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Tooth Demineralization; Tooth Diseases; Asthma; Dental Caries; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Terbutaline
• Other Study ID Numbers: 14422017495367

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No