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Tobacco UseNCT03918902

Snuff Use, Smoking, Periodontitis and Mortality: 30-year Cohort Study From Sweden

An observational study of Tobacco Use and Periodontitis, run by University of Helsinki.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Smoking and dual using associated with poor periodontal health. Read more about this study

Who is it for?
Ages 31 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Tobacco Use, Periodontitis
What is being tested?
Qestinnaires
How many people
1,080 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 1 Apr 2018
How long will I take part?
30 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 31 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Swedish national database sample

Who may be able to join

  • 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.

Who cannot join

  • Other people. Any disease was not an exclusion criteria.

About this study

Smoking and dual using associated with poor periodontal health.

Read the detailed 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.

Being tested
Qestinnaires
Keywords
mortality, oral hygiene, periodontitis, smokeless tobacco, tobacco
Medical subject headings
Tobacco Use, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QestinnairesBehavioural

    Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1985

  2. Calculus index

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

    Measured: 1985

  3. Missing teeth

    Missing teeth were calculated my dentist in clinical examination.

    Measured: 1985

  4. Premature death

    The Swedish National Death Register listing the cumulated causes of all deaths was used in the analyses.

    Measured: From year 1985 to year 2015

  5. Plaque index

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

    Measured: 1985

  6. Gingival index

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

    Measured: 1985

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start1 Jan 2016
  3. Primary completion1 Apr 2018
  4. Study completion1 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,080 participants (actual)
Target duration
30 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03918902
Sponsor's protocol ID
00100
Status last verified
Apr 2019
First submitted
3 Apr 2019
Last updated
18 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Any underlying research materials related to present study could be accessed by e-mail birgitta.soder@ki.se.

Publications

  • 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.

    PubMed 24820118

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

    PubMed 3135084

  • 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.

    PubMed 16899097

  • 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.

    PubMed 28164394

  • 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.

    PubMed 20955584

  • 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.

    PubMed 23574464

  • 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.

    PubMed 14076341

  • 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.

    PubMed 18980511

  • 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.

    PubMed 15953977

  • 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.

    PubMed 21762421

  • 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.

    PubMed 24314326

  • 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.

    PubMed 5237684

  • 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.

    PubMed 28791650

  • 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/

    PubMed 29319988

  • 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.

    PubMed 23955159

Questions about this trial

What is this clinical trial studying?

An observational study of Tobacco Use and Periodontitis, run by University of Helsinki.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Deep periodontal pockets (5mm or over) (time frame: 1985). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03918902, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.

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