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Tobacco UseNCT03614871

Snuff Use, Smoking, Periodontal Health and Premature Death: 30-year Study

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

Snuff use and smoking associated with poor periodontal health, especially if used together. Read more about this study

Who is it for?
Ages 30 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Tobacco Use, Periodontitis
What is being tested?
Epidemiological study
How many people
1,676 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 13 Jul 2018
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 30 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. From the remaining 1519 non-respondents to the initial call, 100 randomly selected subjects, 45 men and 55 women, were reinformed and persuaded and finally agreed to participate in this investigation. They were used as a drop-out control sample.

Who cannot join

  • Other people

About this study

Snuff use and smoking associated with poor periodontal health, especially if used together.

Read the detailed description

Aim: The investigators investigated how snuff use and smoking affect periodontal health parameters and mortality in a Swedish cohort, hypothesizing that snuff use increases the risks.

Material and methods: Study cohort of 1 532 subjects aged 30 to 40 (758 men and 774 women) from Stockholm area was clinically examined and followed up from 1985 to 2015. Associations were analysed between periodontal health parameters, snuff use, smoking and age of death. For analyses, all subjects were classified into four groups: "dual-users" (current and ex-snuffers, current and ex-smokers); "pure snuffers" (current and ex-snuffers); "pure smokers" (non-snuffers, current and ex-smokers) and "non-users" (non-snuffers and non-smokers). Cross-tabulation, chi-square and Fisher's exact tests were used.

Being tested
Epidemiological study
Keywords
Tobacco, Calculus, Gingiva, Oral hygiene, Periodontitis, Biofilm
Medical subject headings
Tobacco Use, Periodontitis, Calculi

What participants receive

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

  • Epidemiological studyOther

Study groups in NCT03614871
Study groupRoleWhat they receive
No armsThere are no interventions
Receives: Other: Epidemiological study

What is being measured

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

  1. Periodontal Pockets

    Dual users, pure snuffers and pure smokers had more ≥5mm deep periodontal pockets than non-users. 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. Missing teeth

    Pure smokers had more likely missing teeth than subjects in other groups. Missing teeth were calculated my dentist in clinical examination.

    Measured: 1985

  3. Gingival Index (GI)

    Dual-users, pure snuffers and pure smokers had higher GI scores than non-users. GI was scored from 0 (no gum bleeding) to 3 (abundant gum bleeding)

    Measured: 1985

  4. Premature death

    Snuff users or smokers did not die earlier than non-users of the cohort in 30 years. 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 (PI)

    Dual-users, pure snuffers and pure smokers had higher PI scores than non-users. PI was scored from 0 (no plaque) to 3 (abundant plaque)

    Measured: 1985

  6. Calculus Index (CI)

    Dual-users, pure snuffers and pure smokers had higher CI scores than non-users. CI was scored from 0 (no calculus) to 3 (abundant calculus) according to Greene \& Vermillion

    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 posted3 Aug 2018
  2. Study start1 Jan 2016
  3. Primary completion1 Jul 2018
  4. Study completion13 Jul 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
Retrospective
Enrolment
1,676 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03614871
Sponsor's protocol ID
00290
Status last verified
Jul 2018
First submitted
23 Jul 2018
Last updated
3 Aug 2018
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

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

    PubMed 16298220

  • 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

  • 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.

    PubMed 29539084

  • 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.

    PubMed 15107054

  • Mattila VM, Raisamo S, Pihlajamaki H, Mantysaari M, Rimpela A. Sports activity and the use of cigarettes and snus among young males in Finland in 1999-2010. BMC Public Health. 2012 Mar 22;12:230. doi: 10.1186/1471-2458-12-230.

    PubMed 22439614

  • 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

  • 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.

    PubMed 26278072

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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.

    PubMed 28411395

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 3 Aug 2018. 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?

Periodontal Pockets (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 NCT03614871, 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 3 Aug 2018.

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