Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03877874
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Somaya Alaa, Cairo University

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
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.

Layout table for study information
Study Type : Observational
Estimated 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Tooth Decay

Group/Cohort Intervention/treatment
Asthmatic children
  • Aironyl syrup(Terbutaline sulfate ................. 1.5mg) 0.075-0.29 mg/ kg body weight 3 times daily
  • Epidrone 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 Epidrone 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



Primary Outcome Measures :
  1. pH of Saliva [ Time Frame: 1year ]
    Digital pH electrode meter


Secondary Outcome Measures :
  1. pattern of Dental caries [ Time Frame: 1year ]
    DMFs/defs index


Other Outcome Measures:
  1. Drug composition(pH and total sugar content) [ Time Frame: 2 minutes ]
    Digital PH electrode meter



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Layout table for additonal information
Responsible Party: Somaya Alaa, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03877874     History of Changes
Other Study ID Numbers: 14422017495367
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Stomatognathic Diseases
Terbutaline
Anti-Asthmatic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action