Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-01-09 @ 11:21 PM
Study NCT ID:
NCT03918902
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2019-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Snuff Use, Smoking, Periodontitis and Mortality: 30-year Cohort Study From Sweden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1080}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-14', 'studyFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2019-04-14', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Deep periodontal pockets (5mm or over)', 'timeFrame': '1985', 'description': 'Periodontal pockets were measured from all teeth and from six surfaces with a Hu-Friedy (PCPUNC 15) periodontal probe (Hu-friedy, Chicago, Ill., USA).'}, {'measure': 'Calculus index', 'timeFrame': '1985', 'description': 'Calculus index was scored from 0 (no calculus) to 3 (abundant calculus) according to Greene \\& Vermillion.'}, {'measure': 'Missing teeth', 'timeFrame': '1985', 'description': 'Missing teeth were calculated my dentist in clinical examination.'}, {'measure': 'Premature death', 'timeFrame': 'From year 1985 to year 2015', 'description': 'The Swedish National Death Register listing the cumulated causes of all deaths was used in the analyses.'}, {'measure': 'Plaque index', 'timeFrame': '1985', 'description': 'Plaque index was scored from 0 (no plaque) to 3 (abundant plaque).'}, {'measure': 'Gingival index', 'timeFrame': '1985', 'description': 'Gingival index was scored from 0 (no gum bleeding) to 3 (abundant gum bleeding).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mortality', 'oral hygiene', 'periodontitis', 'smokeless tobacco', 'tobacco'], 'conditions': ['Tobacco Use', 'Periodontitis']}, 'referencesModule': {'references': [{'pmid': '24820118', 'type': 'BACKGROUND', 'citation': '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': '3135084', 'type': 'BACKGROUND', 'citation': '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': '16899097', 'type': 'BACKGROUND', 'citation': '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': '28164394', 'type': 'BACKGROUND', '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.'}, {'pmid': '20955584', 'type': 'BACKGROUND', 'citation': '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': '23574464', 'type': 'BACKGROUND', '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.'}, {'pmid': '14076341', 'type': 'BACKGROUND', 'citation': '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': '18980511', 'type': 'BACKGROUND', 'citation': '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': '15953977', 'type': 'BACKGROUND', '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. doi: 10.1007/s10552-004-5519-6.'}, {'pmid': '21762421', 'type': 'BACKGROUND', '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.'}, {'pmid': '24314326', 'type': 'BACKGROUND', '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.'}, {'pmid': '5237684', 'type': 'BACKGROUND', 'citation': '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': '28791650', 'type': 'BACKGROUND', 'citation': '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': '29319988', 'type': 'BACKGROUND', 'citation': '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': '23955159', 'type': 'BACKGROUND', '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.'}, {'pmid': '22169061', 'type': 'BACKGROUND', 'citation': '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': '29539084', 'type': 'BACKGROUND', '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.'}, {'pmid': '29926490', 'type': 'BACKGROUND', '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.'}, {'pmid': '16298220', 'type': 'BACKGROUND', 'citation': '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': '15107054', 'type': 'BACKGROUND', 'citation': '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': '26278072', 'type': 'BACKGROUND', '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.'}, {'pmid': '8205774', 'type': 'BACKGROUND', 'citation': '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': '7597634', 'type': 'BACKGROUND', 'citation': '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': '25141188', 'type': 'BACKGROUND', 'citation': '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': '28411395', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Smoking and dual using associated with poor periodontal health.', 'detailedDescription': '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.\n\nMaterial 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '31 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Swedish national database sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Other people. Any disease was not an exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT03918902', 'briefTitle': 'Snuff Use, Smoking, Periodontitis and Mortality: 30-year Cohort Study From Sweden', 'organization': {'class': 'OTHER', 'fullName': 'University of Helsinki'}, 'officialTitle': 'Snuff Use, Smoking, Periodontitis and Mortality: 30-year Cohort Study From Sweden', 'orgStudyIdInfo': {'id': '00100'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Qestinnaires', 'type': 'BEHAVIORAL', 'description': 'Questionnaires'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Any underlying research materials related to present study could be accessed by e-mail birgitta.soder@ki.se.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Helsinki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Julkunen', 'investigatorAffiliation': 'University of Helsinki'}}}}