Impact of smoking on gums
| ISRCTN | ISRCTN13030013 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13030013 |
| Protocol serial number | Ref No: B.30.2.ANK.0.21.63.00/824-02/9-8 |
| Sponsor | Ondokuz Mayıs University |
| Funder | Ondokuz Mayıs University (Turkey) |
- 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
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
Scientific
Ondokuz Mayıs University
Dental Faculty
Samsun
55139
Türkiye
 ORCID ID |
0000-0003-1499-5902 |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | Cross-sectional observational study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| 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(s) |
1. Silness and Loe plaque index |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 30/03/2014 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| 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
Samsun
55139
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/01/2019: Publication reference added
