Asthma in ChildrenNCT04388098
Oral Health Status of Asthmatic Children
An observational study of Asthma in Children, run by Trakya University.
Trial summary
This study aimed to investigate the dental caries experience, periodontal health and salivary properties of asthmatic and non-asthmatic children ⁄ adolescents. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Diagnosis of caries experience and periodontal health
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jun 2019
- 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 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 108 children aged from 7 to 16 years old were included in this study and equally divided into two groups: Group I (asthmatic children) and Group II (healthy control).
Who may be able to join
- Aged between 7-16
- Asthma diagnosis
- Asthma treatment for at least 1 year
- Under asthma medication
- Healthy controls without any systemic condition
Who cannot join
- Asthma diagnosis less than a year
About this study
Official title: Oral Health Status of Asthmatic Children and Adolescents
This study aimed to investigate the dental caries experience, periodontal health and salivary properties of asthmatic and non-asthmatic children ⁄ adolescents.
Read the detailed description
A total of 108 children aged from 7 to 16 years old were included in this study and equally divided into two groups: Group I (asthmatic children) and Group II (healthy control). All the children were clinically examined to assess their dental caries experience and periodontal health condition. A trained and calibrated examiner (kappa = 0.95) performed the dental caries examination according to World Health Organization (WHO) criteria. Dental caries status was recorded using the number of decayed, missing or filled teeth (dmft/DMFT) and decayed, missing or filled surface (dmfs/DMFS) indices. Periodontal health was assessed by gingival index [GI] and plaque index(PI). An interview was conducted with parents/guardians and a structured questionnaire was employed to parents in addition to medical records. Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity.
- Conditions
- Asthma in Children
- Being tested
- Diagnosis of caries experience and periodontal health
- Keywords
- asthma, children, oral health
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of caries experience and periodontal healthOther
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic children | Asthmatic children were clinically examined to assess their dental caries experience and periodontal health condition. Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity. Receives: Other: Diagnosis of caries experience and periodontal health | |
| Non-asthmatic children | Non-asthmatic children were clinically examined to assess their dental caries experience and periodontal health condition. Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity. Receives: Other: Diagnosis of caries experience and periodontal health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health status
Caries experience of asthmatic and non-asthmatic children was recorded using the number of decayed, missing or filled teeth (dmft/DMFT) and decayed, missing or filled surface (dmfs/DMFS) indices. The gingival index (GI) was used to assess the gingival condition according to the criteria of Loe and Silness as follows: no gingival inflammation (<0.1), mild inflammation (0.1-1.0), moderate inflammation (1.1-1.9), and severe inflammation in case of marked gingival redness and edema with spontaneous bleeding and ulceration (2.0-3.0) Plaque index(PI) was used to assess the amount of dental plaque.The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth: A film of plaque adhering to the free gingival margin and adjacent area of the tooth.
Measured: During examination 1 day
salivary flow rate -Salivary characteristics
Stimulated salivary samples were collected and assessed for salivary flow rate. Saliva check buffer kit was used for the measurements according to instructions described on the user guide.
Measured: 5 minutes after saliva collection
salivary pH - Salivary characteristics
Stimulated salivary samples were collected and assessed for salivary pH GC saliva check buffer kit was used for the measurements according to instructions described on the user guide.
Measured: 5 minutes after saliva collection
buffering capacity - Salivary characteristics
Stimulated salivary samples were collected and assessed for buffering capacity. GC saliva check buffer kit was used for the measurements according to instructions described on the user guide.
Measured: 5 minutes after saliva collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study startSep 2016
- Primary completionMay 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ŞİRİN GÜNER ONUR, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388098
- Sponsor's protocol ID
- 2017/210
- Status last verified
- Jun 2020
- First submitted
- 11 May 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Status of Asthmatic Children and Adolescents
- ClinicalTrials.gov ID
- NCT04388098
- Acronym / sponsor ID
- 2017/210
- Conditions
- Asthma in Children
- Keywords
- asthma, children, oral health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 14 May 2020 (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.
This study aimed to investigate the dental caries experience, periodontal health and salivary properties of asthmatic and non-asthmatic children ⁄ adolescents.
Detailed description
A total of 108 children aged from 7 to 16 years old were included in this study and equally divided into two groups: Group I (asthmatic children) and Group II (healthy control). All the children were clinically examined to assess their dental caries experience and periodontal health condition. A trained and calibrated examiner (kappa = 0.95) performed the dental caries examination according to World Health Organization (WHO) criteria. Dental caries status was recorded using the number of decayed, missing or filled teeth (dmft/DMFT) and decayed, missing or filled surface (dmfs/DMFS) indices. Periodontal health was assessed by gingival index [GI] and plaque index(PI). An interview was conducted with parents/guardians and a structured questionnaire was employed to parents in addition to medical records. Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthmatic children | – | Other: Diagnosis of caries experience and periodontal healthAsthmatic children were clinically examined to assess their dental caries experience and periodontal health condition. Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity. |
| Non-asthmatic children | – | Other: Diagnosis of caries experience and periodontal healthNon-asthmatic children were clinically examined to assess their dental caries experience and periodontal health condition. Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 108 children aged from 7 to 16 years old were included in this study and equally divided into two groups: Group I (asthmatic children) and Group II (healthy control).
Key inclusion criteria (5 listed)
- Aged between 7-16
- Asthma diagnosis
- Asthma treatment for at least 1 year
- Under asthma medication
- Healthy controls without any systemic condition
Key exclusion criteria (1 listed)
- Asthma diagnosis less than a year
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 |
|---|---|---|
| Diagnosis of caries experience and periodontal health | Other | Asthmatic children, Non-asthmatic children |
Primary outcome
Oral health status
Time frame: During examination 1 day
Caries experience of asthmatic and non-asthmatic children was recorded using the number of decayed, missing or filled teeth (dmft/DMFT) and decayed, missing or filled surface (dmfs/DMFS) indices. The gingival index (GI) was used to assess the gingival condition according to the criteria of Loe and Silness as follows: no gingival inflammation (<0.1), mild inflammation (0.1-1.0), moderate inflammation (1.1-1.9), and severe inflammation in case of marked gingival redness and edema with spontaneous bleeding and ulceration (2.0-3.0) Plaque index(PI) was used to assess the amount of dental plaque.The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth: A film of plaque adhering to the free gingival margin and adjacent area of the tooth.
salivary flow rate -Salivary characteristics
Time frame: 5 minutes after saliva collection
Stimulated salivary samples were collected and assessed for salivary flow rate. Saliva check buffer kit was used for the measurements according to instructions described on the user guide.
salivary pH - Salivary characteristics
Time frame: 5 minutes after saliva collection
Stimulated salivary samples were collected and assessed for salivary pH GC saliva check buffer kit was used for the measurements according to instructions described on the user guide.
buffering capacity - Salivary characteristics
Time frame: 5 minutes after saliva collection
Stimulated salivary samples were collected and assessed for buffering capacity. GC saliva check buffer kit was used for the measurements according to instructions described on the user guide.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
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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 Asthma in Children, run by Trakya 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 5 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: finished, as of the sponsor's last update on 2 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oral health status (time frame: During examination 1 day). The study lists 4 primary outcomes in all. 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 2 Jul 2020.