pHNCT03877874
The Impact of Anti- Asthmatic Medications on Salivary pH and Dental Caries Pattern in a Group of Egyptian Children With Bronchial Asthma
An observational study of pH, run by Cairo University.
Trial summary
The impact of Anti- Asthmatic medications on salivary pH and dental caries pattern in a Group of Egyptian Children with Bronchial Asthma. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- pH
- What is being tested?
- Aironyl syrup(Terbutaline sulfate) + Epidrone syrup(Dexamethone)
- Type of treatment
- Pill or oral medicine
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- - 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.
Who cannot join
- No other systemic Diseases.
About this study
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
The impact of Anti- Asthmatic medications on salivary pH and dental caries pattern in a Group of Egyptian Children with Bronchial Asthma.
Read the 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.
- Conditions
- pH
- Being tested
- Aironyl syrup(Terbutaline sulfate) + Epidrone syrup(Dexamethone)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aironyl syrup(Terbutaline sulfate) + Epidrone syrup(Dexamethone)Drug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Aironyl syrup(Terbutaline sulfate) + Epidrone syrup(Dexamethone) | |
| Non-Asthmatic children | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH of Saliva
Digital pH electrode meter
Measured: 1year
Secondary outcomes (1)
pattern of Dental caries
DMFs/defs index
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study startJul 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for pHStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somaya Alaa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877874
- Sponsor's protocol ID
- 14422017495367
- Status last verified
- Jan 2021
- First submitted
- 12 Mar 2019
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03877874
- Acronym / sponsor ID
- 14422017495367
- Conditions
- pH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The impact of Anti- Asthmatic medications on salivary pH and dental caries pattern in a Group of Egyptian Children with Bronchial Asthma.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthmatic children | – | 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- - 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.
Key exclusion criteria (1 listed)
- No other systemic Diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Asthmatic children |
Primary outcome
pH of Saliva
Time frame: 1year
Digital pH electrode meter
1 secondary outcome
pattern of Dental caries
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of pH, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pH of Saliva (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.