NCT03918902

Brief Summary

Smoking and dual using associated with poor periodontal health.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,080

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

April 3, 2019

Last Update Submit

April 14, 2019

Conditions

Keywords

mortalityoral hygieneperiodontitissmokeless tobaccotobacco

Outcome Measures

Primary Outcomes (6)

  • 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

  • Calculus index

    Calculus index was scored from 0 (no calculus) to 3 (abundant calculus) according to Greene \& Vermillion.

    1985

  • Missing teeth

    Missing teeth were calculated my dentist in clinical examination.

    1985

  • 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

  • Plaque index

    Plaque index was scored from 0 (no plaque) to 3 (abundant plaque).

    1985

  • Gingival index

    Gingival index was scored from 0 (no gum bleeding) to 3 (abundant gum bleeding).

    1985

Interventions

QestinnairesBEHAVIORAL

Questionnaires

Eligibility Criteria

Age31 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Swedish national database sample

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 24820118BACKGROUND
  • Benowitz NL. Nicotine and smokeless tobacco. CA Cancer J Clin. 1988 Jul-Aug;38(4):244-7. doi: 10.3322/canjclin.38.4.244.

    PMID: 3135084BACKGROUND
  • Bergstrom J, Keilani H, Lundholm C, Radestad U. Smokeless tobacco (snuff) use and periodontal bone loss. J Clin Periodontol. 2006 Aug;33(8):549-54. doi: 10.1111/j.1600-051X.2006.00945.x.

    PMID: 16899097BACKGROUND
  • 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.

    PMID: 28164394BACKGROUND
  • Engstrom 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.

    PMID: 20955584BACKGROUND
  • 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.

    PMID: 23574464BACKGROUND
  • GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.

    PMID: 14076341BACKGROUND
  • Heikkinen AM, Pajukanta R, Pitkaniemi 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.

    PMID: 18980511BACKGROUND
  • 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. doi: 10.1007/s10552-004-5519-6.

    PMID: 15953977BACKGROUND
  • 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.

    PMID: 21762421BACKGROUND
  • 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.

    PMID: 24314326BACKGROUND
  • Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

    PMID: 5237684BACKGROUND
  • Mundel 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.

    PMID: 28791650BACKGROUND
  • Natvig Norderhaug I, Dybing E, Gilljam H, Lind PO, Lund KE, Morland J, Stegmayr B, Hofmann B, Orjasaeter 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. Report from Norwegian Knowledge Centre for the Health Services (NOKC) No. 06-2005. Available from http://www.ncbi.nlm.nih.gov/books/NBK464770/

    PMID: 29319988BACKGROUND
  • 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.

    PMID: 23955159BACKGROUND
  • Norberg M, Malmberg G, Ng N, Brostrom 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.

    PMID: 22169061BACKGROUND
  • 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.

    PMID: 29539084BACKGROUND
  • 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.

    PMID: 29926490BACKGROUND
  • Pihlstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases. Lancet. 2005 Nov 19;366(9499):1809-20. doi: 10.1016/S0140-6736(05)67728-8.

    PMID: 16298220BACKGROUND
  • Seymour GJ, Taylor JJ. Shouts and whispers: An introduction to immunoregulation in periodontal disease. Periodontol 2000. 2004;35:9-13. doi: 10.1111/j.0906-6713.2004.003555.x. No abstract available.

    PMID: 15107054BACKGROUND
  • 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.

    PMID: 26278072BACKGROUND
  • Soder PO, Jin LJ, Soder B, Wikner S. Periodontal status in an urban adult population in Sweden. Community Dent Oral Epidemiol. 1994 Apr;22(2):106-11. doi: 10.1111/j.1600-0528.1994.tb01582.x.

    PMID: 8205774BACKGROUND
  • Soder B, Jin LJ, Soder 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.

    PMID: 7597634BACKGROUND
  • Tanner T, Kamppi A, Pakkila J, Jarvelin MR, Patinen P, Tjaderhane 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.

    PMID: 25141188BACKGROUND
  • 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.

    PMID: 28411395BACKGROUND

MeSH Terms

Conditions

Tobacco UsePeriodontitis

Condition Hierarchy (Ancestors)

BehaviorPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 18, 2019

Study Start

January 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Any underlying research materials related to present study could be accessed by e-mail birgitta.soder@ki.se.