Impact of smoking on gums
| ISRCTN | ISRCTN13030013 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13030013 |
| Secondary identifying numbers | Ref No: B.30.2.ANK.0.21.63.00/824-02/9-8 |
- Submission date
- 15/01/2015
- Registration date
- 04/02/2015
- Last edited
- 22/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
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
Contact information
Dr Muge Lutfioglu
Scientific
Scientific
Ondokuz Mayıs University
Dental Faculty
Samsun
55139
Türkiye
 ORCID ID |
0000-0003-1499-5902 |
|---|
Study information
| Study design | Cross-sectional observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant 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. |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2012 |
| Completion date | 30/03/2014 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15 smokers and 15 non-smoker participants |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2012 |
| Date of final enrolment | 30/03/2014 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Ondokuz Mayıs University
Dental Faculty
Samsun
55139
Türkiye
Samsun
55139
Türkiye
Sponsor information
Ondokuz Mayıs University
University/education
University/education
Dental Faculty
Samsun
55139
Türkiye
"ROR" |
https://ror.org/028k5qw24 |
|---|
Funders
Funder type
University/education
Ondokuz Mayıs University (Turkey)
No information available
Results and Publications
| Intention to publish date | 31/03/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planning to send the manuscript for publication in March 2015 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2016 | 22/01/2019 | Yes | No |
Editorial Notes
22/01/2019: Publication reference added
