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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2019
Source Helsinki University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Smoking and dual using associated with poor periodontal health.


Description:

Aim: To investigate how snuff use, smoking and risk behaviour affect periodontal health and mortality in a Swedish cohort, hypothesizing that they indeed have a poor impact and increase the risk of death.

Material and methods: Study cohort of 1080 subjects aged 31 to 40 years (528 men and 552 women) from Stockholm area was clinically examined in 1985 and followed for mortality until 2015. Associations between periodontal health parameters, snuff use, smoking and age of death were analysed by classifying all subjects into four groups: "dual-users" (current snuffers and current smokers); "pure snuffers" (current non-smoking snuffers); "pure smokers" (current non-snuffing smokers) and "non-users" (non-snuffers, non-smokers). SPSS was used for analyses.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Qestinnaires
Questionnaires

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Helsinki University Karolinska Institutet

References & Publications (25)

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

Pihlstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases. Lancet. 2005 Nov 19;366(9499):1809-20. Review. — View Citation

Seymour GJ, Taylor JJ. Shouts and whispers: An introduction to immunoregulation in periodontal disease. Periodontol 2000. 2004;35:9-13. Review. — View Citation

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

Söder PO, Jin LJ, Söder B, Wikner S. Periodontal status in an urban adult population in Sweden. Community Dent Oral Epidemiol. 1994 Apr;22(2):106-11. — View Citation

Tanner T, Kämppi A, Päkkilä J, Järvelin MR, Patinen P, Tjäderhane L, Anttonen V. Association of smoking and snuffing with dental caries occurrence in a young male population in Finland: a cross-sectional study. Acta Odontol Scand. 2014 Nov;72(8):1017-24. doi: 10.3109/00016357.2014.942877. Epub 2014 Aug 20. — View Citation

Timberlake DS, Nikitin D, Johnson NJ, Altekruse SF. A longitudinal study of smokeless tobacco use and mortality in the United States. Int J Cancer. 2017 Jul 15;141(2):264-270. doi: 10.1002/ijc.30736. Epub 2017 Apr 24. — View Citation

* Note: There are 25 references in allClick here to view all references

Outcome

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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