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

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03877874
• Collaborator: (none)
• Enrollment: 58
• Anticipated Duration (Months): 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
pH	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 Design

• Study Type: Observational
• Anticipated Enrollment: 58 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: 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
• Anticipated Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Sep 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. pH of Saliva [1year]

   Digital pH electrode meter

Secondary Outcome Measures

1. pattern of Dental caries [1year]

   DMFs/defs index

Other Outcome Measures

1. Drug composition(pH and total sugar content) [2 minutes]

   Digital PH electrode meter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Somaya Alaa, Principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03877874
• Other Study ID Numbers: 14422017495367
• First Posted: Mar 18, 2019
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Caries; Asthma; Terbutaline

Study Results

No Results Posted as of Feb 1, 2021