Innate ImmunityNCT03639376
Passive Smoking and LL-37 in Children
An observational study of Innate Immunity and Periodontal Health, run by Kırıkkale University.
Trial summary
This study investigates the salivary LL-37 in passive smoking-exposed and unexposed children and the association between salivary LL-37 levels and periodontal clinical parameters in these children.Unstimulated salivary samples were collected from 180 children (90 passive smoking-exposed and 90 passive… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Innate Immunity, Periodontal Health
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jun 2018
- 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 children were selected from patients referred to Kirikkale University, Faculty of Dentistry, and Department of Pediatric Dentistry
Who may be able to join
- Systemically healthy children
Who cannot join
- Any medications known to affect defense system and periodontium
- The presence of orthodontic / intraoral appliance
About this study
Official title: Salivary LL-37 and Periodontal Health in Children Exposed to Passive Smoking
This study investigates the salivary LL-37 in passive smoking-exposed and unexposed children and the association between salivary LL-37 levels and periodontal clinical parameters in these children.Unstimulated salivary samples were collected from 180 children (90 passive smoking-exposed and 90 passive smoking-unexposed)
Read the detailed description
Diverse mechanisms conduce to the detrimental periodontal effects of passive smoking, including alteration of both microbial and host response factors.
Antimicrobial peptides are considered to be an important intermediate step in initiating an initial immune response against the microbial side of the oral gingival epithelium and in the transition to acquired immunity.
LL-37 has a wide antimicrobial activity against both cariogenic and periopathogenic bacteria and its role in maintaining oral health has recently been stated
- Conditions
- Innate Immunity, Periodontal Health
- Keywords
- Children, Cotinine, LL-37, Passive smoking, Periodontal health, Saliva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Passive smoking-exposed children | This group consists of children whose family members have smoked at home since the birth of the child. | |
| Passive smoking-unexposed children | This group consists of children whose family members have not smoked at home since the birth of the child. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial Peptide
LL-37 (pg/mL)
Measured: In the first 18 months of study
Secondary outcomes (1)
Passive smoking measurement
Cotinine (ng/mL)
Measured: In the first 18 months of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startNov 2016
- Primary completionApr 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Innate ImmunityStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Karsiyaka Hendek, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639376
- Sponsor's protocol ID
- 2016/140
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary LL-37 and Periodontal Health in Children Exposed to Passive Smoking
- ClinicalTrials.gov ID
- NCT03639376
- Acronym / sponsor ID
- 2016/140
- Conditions
- Innate Immunity, Periodontal Health
- Keywords
- Children, Cotinine, LL-37, Passive smoking, Periodontal health, Saliva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 21 Aug 2018 (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 investigates the salivary LL-37 in passive smoking-exposed and unexposed children and the association between salivary LL-37 levels and periodontal clinical parameters in these children.Unstimulated salivary samples were collected from 180 children (90 passive smoking-exposed and 90 passive smoking-unexposed)
Detailed description
Diverse mechanisms conduce to the detrimental periodontal effects of passive smoking, including alteration of both microbial and host response factors.
Antimicrobial peptides are considered to be an important intermediate step in initiating an initial immune response against the microbial side of the oral gingival epithelium and in the transition to acquired immunity.
LL-37 has a wide antimicrobial activity against both cariogenic and periopathogenic bacteria and its role in maintaining oral health has recently been stated
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive smoking-exposed children | – | –This group consists of children whose family members have smoked at home since the birth of the child. |
| Passive smoking-unexposed children | – | –This group consists of children whose family members have not smoked at home since the birth of the child. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All children were selected from patients referred to Kirikkale University, Faculty of Dentistry, and Department of Pediatric Dentistry
Key inclusion criteria (1 listed)
- Systemically healthy children
Key exclusion criteria (2 listed)
- Any medications known to affect defense system and periodontium
- The presence of orthodontic / intraoral appliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antimicrobial Peptide
Time frame: In the first 18 months of study
LL-37 (pg/mL)
1 secondary outcome
Passive smoking measurement
Time frame: In the first 18 months of study
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 21 Aug 2018.
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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 Innate Immunity and Periodontal Health, run by Kırıkkale 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 1 inclusion and 2 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 21 Aug 2018. 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?
Antimicrobial Peptide (time frame: In the first 18 months of study). 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 21 Aug 2018.