NCT03614871

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,676

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
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
Last Updated

August 3, 2018

Status Verified

July 1, 2018

Enrollment Period

2.5 years

First QC Date

July 23, 2018

Last Update Submit

July 30, 2018

Conditions

Keywords

TobaccoCalculusGingivaOral hygienePeriodontitisBiofilm

Outcome Measures

Primary Outcomes (6)

  • 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).

    1985

  • Missing teeth

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

    1985

  • 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)

    1985

  • 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.

    From year 1985 to year 2015

  • 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)

    1985

  • 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

    1985

Study Arms (1)

No arms

There are no interventions

Other: Epidemiological study

Interventions

Eligibility Criteria

Age30 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. 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.

You may not qualify if:

  • Other people

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (25)

  • 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
  • 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
  • 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
  • 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
  • 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.

    PMID: 22439614BACKGROUND
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

MeSH Terms

Conditions

Tobacco UsePeriodontitisCalculi

Interventions

Epidemiologic Studies

Condition Hierarchy (Ancestors)

BehaviorPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 3, 2018

Study Start

January 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 13, 2018

Last Updated

August 3, 2018

Record last verified: 2018-07

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.