PeriodontitisNCT03923218
Effects of Smoking and Vitamin D3 on the Levels of Human Cathelicidin Peptide LL-37
An observational study of Periodontitis, run by Gazi University.
Trial summary
The aims of our study were 1) to evaluate levels of gingival crevicular fluid( GCF) human cathelicidin peptide LL-37 and serum vitamin D3 in smoker and non-smoker patients with chronic periodontitis(CP) 2) to determine whether any correlation between GCF LL-37 and vitamin D3 serum levels exist and 3) to asses the… Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- LL-37 levels in Gingival crevicular fluid, Serum Vitamin D3 levels and Clinical parameters
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Jul 2015
- 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The volunteers participitating in the study were choosen from among individuals scheduled to undergo either dental treatment or dental check at the Deparment of Perioodontology, Faculty of Dentistry, Gazi University, Ankara, Turkey.
Who may be able to join
- Clinical attachment loss ≥ 5mm
- Probing depth ≥5mm
- Bone loss affecting >30% of the existing teeth on clinical and radiographic examination
- gingival index (GI) score> 1
- full-mouth PD was≤ 3mm,
- Gingival index <1
Show all 11Show fewer
- there was no indication of Attachment Loss or no radiographic evidence of alveolar bone loss in control group.
- Non-smokers.
- Smoking criteria for groups:
- patients smoked more than 10 cigarettes in a day
- smoking for 3 or more years,
Who cannot join
- systemic condition (diabetes, cardiovascular disease, immunologic disorders, hepatitis, e.g.)
- pregnancy, lactation or menopause term,
- antibiotic treatment or non-steroidal anti-inflammatory medications within the last 3 months before the study,
- non-surgical periodontal treatment during the last 6 months before the study,
- treatment with Vitamin D supplementation before the study
About this study
Official title: Evaluation of Gingival Crevicular Fluid Levels of LL-37 and Serum Vitamin D3 Levels in Smoker and Non-Smoker Patients With Chronic Periodontitis
The aims of our study were 1) to evaluate levels of gingival crevicular fluid( GCF) human cathelicidin peptide LL-37 and serum vitamin D3 in smoker and non-smoker patients with chronic periodontitis(CP) 2) to determine whether any correlation between GCF LL-37 and vitamin D3 serum levels exist and 3) to asses the correlation between clinical parameters and biochemical markers
Read the detailed description
Background: Cathelicidin LL-37, an antimicrobial peptide, is part of the host innate immune response in the oral cavity. The aims of this study are to evaluate; gingival crevicular fluid (GCF) levels of LL-37, serum vitamin D3 levels and periodontal clinical recordings in smoker and nonsmoker patients with chronic periodontitis (CP).
Methods:
This study consisted a total of 60 volunteers including 20 smoker patients with CP (CP-1 group), 20 non-smoker patients with CP (CP-2 group) and 20 periodontally healthy subjects (CTRL group). Prior to participation, the design and purpose of the research were explained to each subjects, and written informed consent form was obtained from 60 individuals before the study.
The periodontal status of the patients were determined by measuring the probing depth (PD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) All clinical parameters were measured on six sites per tooth from the full-mouth teeth (mesiobuccal, distobuccal,midbuccal, mesiolingual, distolingual and midlingual) using a William's periodontal probe calibrated in millimeters by the same examiner. All samples were obtained on the day following clinical examinations of the individuals. The deepest six pockets site per individual were chosen for collection of GCF across both of the periodontitis groups. Six pocket locations showing a lack of clinical inflammation were also tested to guarantee collection of a sufficient volume of GCF across the CTRL groups.
GCF levels of LL-37 were measured by ELISA and serum levels of vitamin D3 were analysed by High-performance liquid chromatography (HPLC). Statistical analysis were performed.
- Conditions
- Periodontitis
- Being tested
- LL-37 levels in Gingival crevicular fluid, Serum Vitamin D3 levels, Clinical parameters
- Keywords
- Gingival crevicular fluid, Vitamin D, LL-37, Serum, periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LL-37 levels in Gingival crevicular fluidOther
Collected gingival crevicular fluid
Serum Vitamin D3 levelsOther
Collected serum
Clinical parametersOther
Recorded plague index, gingival index, probing depth, clinical attachment level
| Study group | Role | What they receive |
|---|---|---|
| Smoker patients with chronic periodontitis | Smoker patients with chronic periodontitis Receives: Other: LL-37 levels in Gingival crevicular fluid; Other: Serum Vitamin D3 levels; Other: Clinical parameters | |
| non-smoker patients with chronic periodontitis | non-smoker patients with chronic periodontitis Receives: Other: LL-37 levels in Gingival crevicular fluid; Other: Serum Vitamin D3 levels; Other: Clinical parameters | |
| periodontally healthy patients | periodontally healthy patients Receives: Other: LL-37 levels in Gingival crevicular fluid; Other: Serum Vitamin D3 levels; Other: Clinical parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum D3 Vitamin levels
The plasma levels of vitamin D3 were greater in the CP-2 group than in the CP-1 group. But, no statistically significant difference was determined between the CP groups (P>0.05)
Measured: Baseline
Gingival Crevicular fluid(GCF) LL-37 levels
The concentration of LL-37 in GCF was significantly higher in both of the CP groups than in the CTRL group (p<0.001). Although GCF LL-37 concentration levels were greater in the CP-1 group than in the CP-2 group, the difference did not reach the statistical significance between the CP groups (p>0.05).
Measured: Baseline
Secondary outcomes (5)
Plaque index (PI)
The full-mouth and sample sites PI recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p<0.001).
were measured on six sites per tooth from the full-mouth teeth
Measured: Baseline
GCF volume
The GCF volume was notably higher in both CP groups than in CTRL group (p<0.001).
Measured: Baseline
gingival index (GI)
The full-mouth and sample sites GI recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p<0.001).
Measured: Baseline
Probing depth (PD)
The full-mouth and sample sites PD recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p<0.001).
Measured: Baseline
Clinical attachment level (CAL)
The full-mouth and sample sites CAL recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p<0.001).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study startDec 2011
- Primary completionJul 2012
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Tüter, Gazi University
- Investigators
- Şeyma BOZKURT DOĞAN, Professor, Principal investigator, universityElifcan Kıvrak, PhD, Principal investigator, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923218
- Sponsor's protocol ID
- 03/2011-27
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 22 Apr 2019
- 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 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gingival Crevicular Fluid Levels of LL-37 and Serum Vitamin D3 Levels in Smoker and Non-Smoker Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03923218
- Acronym / sponsor ID
- 03/2011-27
- Conditions
- Periodontitis
- Keywords
- Gingival crevicular fluid, Vitamin D, LL-37, Serum, periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Apr 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 aims of our study were 1) to evaluate levels of gingival crevicular fluid( GCF) human cathelicidin peptide LL-37 and serum vitamin D3 in smoker and non-smoker patients with chronic periodontitis(CP) 2) to determine whether any correlation between GCF LL-37 and vitamin D3 serum levels exist and 3) to asses the correlation between clinical parameters and biochemical markers
Detailed description
Background: Cathelicidin LL-37, an antimicrobial peptide, is part of the host innate immune response in the oral cavity. The aims of this study are to evaluate; gingival crevicular fluid (GCF) levels of LL-37, serum vitamin D3 levels and periodontal clinical recordings in smoker and nonsmoker patients with chronic periodontitis (CP).
Methods:
This study consisted a total of 60 volunteers including 20 smoker patients with CP (CP-1 group), 20 non-smoker patients with CP (CP-2 group) and 20 periodontally healthy subjects (CTRL group). Prior to participation, the design and purpose of the research were explained to each subjects, and written informed consent form was obtained from 60 individuals before the study.
The periodontal status of the patients were determined by measuring the probing depth (PD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) All clinical parameters were measured on six sites per tooth from the full-mouth teeth (mesiobuccal, distobuccal,midbuccal, mesiolingual, distolingual and midlingual) using a William's periodontal probe calibrated in millimeters by the same examiner. All samples were obtained on the day following clinical examinations of the individuals. The deepest six pockets site per individual were chosen for collection of GCF across both of the periodontitis groups. Six pocket locations showing a lack of clinical inflammation were also tested to guarantee collection of a sufficient volume of GCF across the CTRL groups.
GCF levels of LL-37 were measured by ELISA and serum levels of vitamin D3 were analysed by High-performance liquid chromatography (HPLC). Statistical analysis were performed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smoker patients with chronic periodontitis | – | Other: LL-37 levels in Gingival crevicular fluid, Other: Serum Vitamin D3 levels, Other: Clinical parametersSmoker patients with chronic periodontitis |
| non-smoker patients with chronic periodontitis | – | Other: LL-37 levels in Gingival crevicular fluid, Other: Serum Vitamin D3 levels, Other: Clinical parametersnon-smoker patients with chronic periodontitis |
| periodontally healthy patients | – | Other: LL-37 levels in Gingival crevicular fluid, Other: Serum Vitamin D3 levels, Other: Clinical parametersperiodontally healthy patients |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The volunteers participitating in the study were choosen from among individuals scheduled to undergo either dental treatment or dental check at the Deparment of Perioodontology, Faculty of Dentistry, Gazi University, Ankara, Turkey.
Key inclusion criteria (11 listed)
- Clinical attachment loss ≥ 5mm
- Probing depth ≥5mm
- Bone loss affecting >30% of the existing teeth on clinical and radiographic examination
- gingival index (GI) score> 1
- full-mouth PD was≤ 3mm,
Key exclusion criteria (5 listed)
- systemic condition (diabetes, cardiovascular disease, immunologic disorders, hepatitis, e.g.)
- pregnancy, lactation or menopause term,
- antibiotic treatment or non-steroidal anti-inflammatory medications within the last 3 months before the study,
- non-surgical periodontal treatment during the last 6 months before the study,
- treatment with Vitamin D supplementation before the study
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 |
|---|---|---|
| LL-37 levels in Gingival crevicular fluidCollected gingival crevicular fluid | Other | Smoker patients with chronic periodontitis, non-smoker patients with chronic periodontitis, periodontally healthy patients |
| Serum Vitamin D3 levelsCollected serum | Other | Smoker patients with chronic periodontitis, non-smoker patients with chronic periodontitis, periodontally healthy patients |
| Clinical parametersRecorded plague index, gingival index, probing depth, clinical attachment level | Other | Smoker patients with chronic periodontitis, non-smoker patients with chronic periodontitis, periodontally healthy patients |
Primary outcome
Serum D3 Vitamin levels
Time frame: Baseline
The plasma levels of vitamin D3 were greater in the CP-2 group than in the CP-1 group. But, no statistically significant difference was determined between the CP groups (P>0.05)
Gingival Crevicular fluid(GCF) LL-37 levels
Time frame: Baseline
The concentration of LL-37 in GCF was significantly higher in both of the CP groups than in the CTRL group (p<0.001). Although GCF LL-37 concentration levels were greater in the CP-1 group than in the CP-2 group, the difference did not reach the statistical significance between the CP groups (p>0.05).
5 secondary outcomes
Plaque index (PI)
Time frame: Baseline
GCF volume
Time frame: Baseline
gingival index (GI)
Time frame: Baseline
Probing depth (PD)
Time frame: Baseline
Clinical attachment level (CAL)
Time frame: Baseline
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 22 Apr 2019.
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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.
Şeyma BOZKURT DOĞAN, Professor principal investigator
university
Elifcan Kıvrak, PhD principal investigator
university
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Gazi 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 11 inclusion and 5 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 22 Apr 2019. 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?
Serum D3 Vitamin levels (time frame: Baseline). The study lists 2 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 22 Apr 2019.