Condition category
Oral Health
Date applied
15/01/2015
Date assigned
04/02/2015
Last edited
04/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Ondokuz Mayıs University

Sponsor details

Dental Faculty
Samsun
55139
Turkey

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes