Periodontitis Clinical Trial
Official title:
Snuff Use, Smoking, Periodontitis and Mortality: 30-year Cohort Study From Sweden
NCT number | NCT03918902 |
Other study ID # | 00100 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2016 |
Est. completion date | April 1, 2018 |
Verified date | April 2019 |
Source | Helsinki University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Smoking and dual using associated with poor periodontal health.
Status | Completed |
Enrollment | 1080 |
Est. completion date | April 1, 2018 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 31 Years to 40 Years |
Eligibility |
Inclusion Criteria: - In 1985-1986 a sample was selected from the registry file of all inhabitants of the Stockholm area, of people born on the 20th of any month from 1945 to 1954.The sample comprised 3200 people. They were informed about the purpose of the study and called for clinical investigation. 1681 (52.5%) individuals, 840 men and 841 women, participated in the study. Subjects had different socio-economic and health backgrounds. Exclusion Criteria: - Other people. Any disease was not an exclusion criteria. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Helsinki University | Karolinska Institutet |
An N, Andrukhov O, Tang Y, Falkensammer F, Bantleon HP, Ouyang X, Rausch-Fan X. Effect of nicotine and porphyromonas gingivalis lipopolysaccharide on endothelial cells in vitro. PLoS One. 2014 May 12;9(5):e96942. doi: 10.1371/journal.pone.0096942. eCollection 2014. — View Citation
Benowitz NL. Nicotine and smokeless tobacco. CA Cancer J Clin. 1988 Jul-Aug;38(4):244-7. Review. — View Citation
Bergström J, Keilani H, Lundholm C, Rådestad U. Smokeless tobacco (snuff) use and periodontal bone loss. J Clin Periodontol. 2006 Aug;33(8):549-54. — View Citation
Carlsson S, Andersson T, Araghi M, Galanti R, Lager A, Lundberg M, Nilsson P, Norberg M, Pedersen NL, Trolle-Lagerros Y, Magnusson C. Smokeless tobacco (snus) is associated with an increased risk of type 2 diabetes: results from five pooled cohorts. J Intern Med. 2017 Apr;281(4):398-406. doi: 10.1111/joim.12592. Epub 2017 Feb 6. — View Citation
Engström K, Magnusson C, Galanti MR. Socio-demographic, lifestyle and health characteristics among snus users and dual tobacco users in Stockholm County, Sweden. BMC Public Health. 2010 Oct 18;10:619. doi: 10.1186/1471-2458-10-619. — View Citation
Genco RJ, Borgnakke WS. Risk factors for periodontal disease. Periodontol 2000. 2013 Jun;62(1):59-94. doi: 10.1111/j.1600-0757.2012.00457.x. Review. — View Citation
GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. — View Citation
Heikkinen AM, Pajukanta R, Pitkäniemi J, Broms U, Sorsa T, Koskenvuo M, Meurman JH. The effect of smoking on periodontal health of 15- to 16-year-old adolescents. J Periodontol. 2008 Nov;79(11):2042-7. doi: 10.1902/jop.2008.080205 . — View Citation
Henley SJ, Thun MJ, Connell C, Calle EE. Two large prospective studies of mortality among men who use snuff or chewing tobacco (United States). Cancer Causes Control. 2005 May;16(4):347-58. — View Citation
Hugoson A, Rolandsson M. Periodontal disease in relation to smoking and the use of Swedish snus: epidemiological studies covering 20 years (1983-2003). J Clin Periodontol. 2011 Sep;38(9):809-16. doi: 10.1111/j.1600-051X.2011.01749.x. Epub 2011 Jul 18. — View Citation
Lee PN. Epidemiological evidence relating snus to health--an updated review based on recent publications. Harm Reduct J. 2013 Dec 6;10:36. doi: 10.1186/1477-7517-10-36. Review. — View Citation
Löe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. — View Citation
Mündel T. Nicotine: Sporting Friend or Foe? A Review of Athlete Use, Performance Consequences and Other Considerations. Sports Med. 2017 Dec;47(12):2497-2506. doi: 10.1007/s40279-017-0764-5. Review. — View Citation
Natvig Norderhaug I, Dybing E, Gilljam H, Lind PO, Lund KE, Mørland J, Stegmayr B, Hofmann B, Ørjasæter Elvsaas IK. Health Effects and Dependency Associated with Snuff Consumption [Internet]. Oslo, Norway: Knowledge Centre for the Health Services at The Norwegian Institute of Public Health (NIPH); 2005 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK464770/ — View Citation
Nibali L, Farias BC, Vajgel A, Tu YK, Donos N. Tooth loss in aggressive periodontitis: a systematic review. J Dent Res. 2013 Oct;92(10):868-75. doi: 10.1177/0022034513501878. Epub 2013 Aug 16. Review. — View Citation
Norberg M, Malmberg G, Ng N, Broström G. Who is using snus? - Time trends, socioeconomic and geographic characteristics of snus users in the ageing Swedish population. BMC Public Health. 2011 Dec 14;11:929. doi: 10.1186/1471-2458-11-929. — View Citation
Page RC, Eke PI. Case Definitions for Use in Population-Based Surveillance of Periodontitis. J Periodontol. 2007 Jul;78 Suppl 7S:1387-1399. doi: 10.1902/jop.2007.060264. — View Citation
Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946. — View Citation
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Siddiqi K, Shah S, Abbas SM, Vidyasagaran A, Jawad M, Dogar O, Sheikh A. Global burden of disease due to smokeless tobacco consumption in adults: analysis of data from 113 countries. BMC Med. 2015 Aug 17;13:194. doi: 10.1186/s12916-015-0424-2. — View Citation
Söder B, Jin LJ, Söder PO, Wikner S. Clinical characteristics of destructive periodontitis in a risk group of Swedish urban adults. Swed Dent J. 1995;19(1-2):9-15. — View Citation
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Deep periodontal pockets (5mm or over) | Periodontal pockets were measured from all teeth and from six surfaces with a Hu-Friedy (PCPUNC 15) periodontal probe (Hu-friedy, Chicago, Ill., USA). | 1985 | |
Primary | Calculus index | Calculus index was scored from 0 (no calculus) to 3 (abundant calculus) according to Greene & Vermillion. | 1985 | |
Primary | Missing teeth | Missing teeth were calculated my dentist in clinical examination. | 1985 | |
Primary | Premature death | The Swedish National Death Register listing the cumulated causes of all deaths was used in the analyses. | From year 1985 to year 2015 | |
Primary | Plaque index | Plaque index was scored from 0 (no plaque) to 3 (abundant plaque). | 1985 | |
Primary | Gingival index | Gingival index was scored from 0 (no gum bleeding) to 3 (abundant gum bleeding). | 1985 |
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