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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:
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ISRCTN |
Last refreshed on:
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11 February 2019 |
Main ID: |
ISRCTN13030013 |
Date of registration:
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04/02/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Impact of smoking on gums
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Scientific title:
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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:
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01/09/2012 |
Target sample size:
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30 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN13030013 |
Study type:
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Observational |
Study design:
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Cross-sectional observational study (Other)
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Phase:
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Muge
Lutfioglu |
Address:
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Ondokuz Mayis University
Dental Faculty
55139
Samsun
Turkey |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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Secondary ID(s)
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Ref No: B.30.2.ANK.0.21.63.00/824-02/9-8
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Source(s) of Monetary Support
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Ondokuz Mayis University (Turkey)
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Ethics review
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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
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/03/2014 |
URL:
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