World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 11 February 2019
Main ID:  ISRCTN13030013
Date of registration: 04/02/2015
Prospective Registration: No
Primary sponsor: Ondokuz Mayis University
Public title: Impact of smoking on gums
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
Date of first enrolment: 01/09/2012
Target sample size: 30
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN13030013
Study type:  Observational
Study design:  Cross-sectional observational study (Other)  
Phase: 
Countries of recruitment
Turkey
Contacts
Name: Muge    Lutfioglu
Address:  Ondokuz Mayis University Dental Faculty 55139 Samsun Turkey
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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

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


Age minimum:
Age maximum:
Gender: Both
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.
Oral Health
Periodontial disease
Intervention(s)

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
Primary Outcome(s)

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(s)
Secondary ID(s)
Ref No: B.30.2.ANK.0.21.63.00/824-02/9-8
Source(s) of Monetary Support
Ondokuz Mayis University (Turkey)
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
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
Results
Results available: Yes
Date Posted:
Date Completed: 30/03/2014
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history