Plain English Summary
Background and study aims
Cigarette smoking is one of the major risk factors for gum disease. The aim in this study is to assess the impact of cigarette smoking on healthy and diseased gum tissue.
Who can participate?
Adult smokers and non-smokers
What does the study involve?
Samples will be obtained of the fluid secreted where the gums meet the teeth.
What are the possible benefits and risks of participating?
There are no known benefits to participants taking part in this study. There are no known risks to participants taking part in this study.
Where is the study run from?
Ondokuz Mayıs University (Turkey)
When is the study starting and how long is it expected to run for?
From September 2012 to March 2014
Who is funding the study?
Ondokuz Mayıs University (Turkey)
Who is the main contact?
Associate Professor Muge Lutfioglu
Trial website
Contact information
Type
Scientific
Primary contact
Assocociate Professor Muge Lutfioglu
ORCID ID
http://orcid.org/0000-0003-1499-5902
Contact details
Ondokuz Mayıs University
Dental Faculty
Samsun
55139
Turkey
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Ref No: B.30.2.ANK.0.21.63.00/824-02/9-8
Study information
Scientific title
Interleukin 8 and lipoxin a4 levels in the gingival crevicular fluid of smokers and non-smokers with different periodontal diseases: a cross-sectional study
Acronym
Study hypothesis
Investigate the effect of cigarette smoking on gingival crevicular fuid levels of interleukin 8 and lipoxin A4, cytokines that affect the polymorphonuclear functions in inflammatory response, in healthy individuals and those with periodontal disease because:
1. Cigarette smoking is one of the major risk factors for periodontal disease and has effects on the pathogenesis of the periodontal disease.
2. Smoking alters the host's response, including vascular function, neutrophil/monocyte activities, adhesion molecule expression, antibody production and cytokine and inflammatory mediator release.
3. Loss of proinflammatory mediators is the turn off signal for inflammation, ending subsequent responses passively
4. Resolution of inflammation and the return to homoeostasis is an active and highly regulated biochemical process that is thought to be programmed at the tissue level.
5. Failure to the remove the noxious products of smoking will have negative effects on cellular functions of the ımmune system and inflammatory cells might cause chronic and pathological lesions in healthy and diseased periodontal tissues.
6. Specialised immunoresolvents comprise endogeneous molecules including resolvins, lipoxins, protectins and maresins, which actively drive the termination of the inflammation.
Ethics approval
Local ethics committee of the Dental School of Ankara University, 19/07/2011, reference number B.30.2.ANK.0.21.63.00/824-02/9-8
Study design
Cross-sectional observational study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
A study population of smokers and nonsmokers was selected regarding the criteria: (i) to be ≥ 18 years of age and having ≥ 16 teeth, (ii) not to have previous periodontal therapy in the last 6 months, and (iii) not to have any systemic problems and regular/current (at least 6 weeks prior to data collection) chemotherapeutic regimens. Smoking status was determined as ≥ 5 years of duration and as ≥ 15 per day of consumption in all smokers, whereas non-smoking status included individuals who never smoked before.
Condition
Periodontial disease is a leucocyte-mediated inflammatory disease characterised by inflammation of the supporting tissues of the teeth induced by micro-organisms that stimulate the host immune and inflammatory responses.
Intervention
Gingival crevicular fluid samples will be obtained from the orifice of the gingival pocket, using commercially available periopaper strips for the assessment of:
1. Plaque index
2. Gingival index
3. Probing depth
4. Clinical attachment level
5. Bleeding on probing
Intervention type
Other
Phase
Drug names
Primary outcome measures
1. Silness and Loe plaque index
2. Loe and Silness gingival index
3. Probing pocket depth
4. Clinical attachment level
5. Bleeding on probing
Clinical measurements will be performed on six sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingua and, disto-lingual) using a Williams periodontal probe calibrated in millimetres on the patient's first visit to have periodontal treatment.
Secondary outcome measures
N/A
Overall trial start date
01/09/2012
Overall trial end date
30/03/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Smokers (≥ 5 years of duration and ≥ 15 cigarettes per day)
2. Non-smokers (never smoked)
3. Age ≥ 18 years old
4. ≥ 16 teeth
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
15 smokers and 15 non-smoker participants
Participant exclusion criteria
1. History of cancer
2. History of rheumatoid arthritis
3. History of diabetes mellitus
4. History of cardiovascular diseases
5. Compromised immune system
6. Pregnancy
7. Menopause
8. Lactating
9. Ongoing drug therapy that may affect the clinical features of periodontitis
10. Systemic antimicrobials during the 6 weeks preceding the baseline examination
11. Any dental treatment during the past 6 months
Recruitment start date
01/09/2012
Recruitment end date
30/03/2014
Locations
Countries of recruitment
Turkey
Trial participating centre
Ondokuz Mayıs University
Dental Faculty
Samsun
55139
Turkey
Funders
Funder type
University/education
Funder name
Ondokuz Mayıs University (Turkey)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planning to send the manuscript for publication in March 2015
Intention to publish date
31/03/2015
Participant level data
Available on request
Results - basic reporting
Publication summary