Periodontitis Clinical Trial
Official title:
Snuff Use, Smoking, Periodontal Health and Premature Death: 30-year Study
NCT number | NCT03614871 |
Other study ID # | 00290 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2016 |
Est. completion date | July 13, 2018 |
Verified date | July 2018 |
Source | Helsinki University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Snuff use and smoking associated with poor periodontal health, especially if used together.
Status | Completed |
Enrollment | 1676 |
Est. completion date | July 13, 2018 |
Est. primary completion date | July 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Other people |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Helsinki University | Karolinska Institutet |
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. — View Citation
Benowitz NL. Nicotine and smokeless tobacco. CA Cancer J Clin. 1988 Jul-Aug;38(4):244-7. Review. — View Citation
Bergström J, Keilani H, Lundholm C, Rådestad U. Smokeless tobacco (snuff) use and periodontal bone loss. J Clin Periodontol. 2006 Aug;33(8):549-54. — View 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. — View Citation
Engström 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. — View 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. Review. — View Citation
GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. — View Citation
Heikkinen AM, Pajukanta R, Pitkäniemi 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 . — View 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. — View 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. — View 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. Review. — View Citation
Löe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. — View Citation
Mattila VM, Raisamo S, Pihlajamäki H, Mäntysaari M, Rimpelä 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. — View Citation
Mündel 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. Review. — View Citation
Natvig Norderhaug I, Dybing E, Gilljam H, Lind PO, Lund KE, Mørland J, Stegmayr B, Hofmann B, Ørjasæter 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. Available from http://www.ncbi.nlm.nih.gov/books/NBK464770/ — View 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. Review. — View Citation
Norberg M, Malmberg G, Ng N, Broström 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. — View 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. — View Citation
Pihlstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases. Lancet. 2005 Nov 19;366(9499):1809-20. Review. — View Citation
Seymour GJ, Taylor JJ. Shouts and whispers: An introduction to immunoregulation in periodontal disease. Periodontol 2000. 2004;35:9-13. Review. — View 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. — View Citation
Söder B, Jin LJ, Söder 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. — View Citation
Söder PO, Jin LJ, Söder B, Wikner S. Periodontal status in an urban adult population in Sweden. Community Dent Oral Epidemiol. 1994 Apr;22(2):106-11. — View Citation
Tanner T, Kämppi A, Päkkilä J, Järvelin MR, Patinen P, Tjäderhane 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. — View 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. — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Missing teeth | Pure smokers had more likely missing teeth than subjects in other groups. Missing teeth were calculated my dentist in clinical examination. | 1985 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04712630 -
Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft
|
N/A | |
Completed |
NCT06127069 -
Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device
|
N/A | |
Completed |
NCT04964167 -
Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis
|
Phase 4 | |
Completed |
NCT05906797 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
|
N/A | |
Recruiting |
NCT03997552 -
NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration
|
N/A | |
Completed |
NCT05530252 -
Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis
|
Phase 4 | |
Completed |
NCT04881357 -
Antiplaque/Antigingivitis Effect of Lacer Oros Integral
|
N/A | |
Recruiting |
NCT03790605 -
A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis
|
Phase 3 | |
Enrolling by invitation |
NCT04971174 -
Outcomes of Periodontal Regenerative Treatment
|
||
Not yet recruiting |
NCT05568290 -
Interleukin-38 Levels in Individuals With Periodontitis
|
||
Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
Recruiting |
NCT03997578 -
Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects
|
N/A | |
Completed |
NCT03901066 -
Smoking Dependence and Periodontitis
|
||
Enrolling by invitation |
NCT04956211 -
Periodontal Treatment and Ischemic Stroke
|
N/A | |
Recruiting |
NCT05971706 -
Ozone Application in Periodontal Treatment
|
N/A | |
Recruiting |
NCT06099574 -
A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora
|
||
Completed |
NCT04402996 -
Meteorin-like Levels in Individuals With Periodontitis
|
||
Active, not recruiting |
NCT05311657 -
Oral Health and Severe COPD
|
||
Not yet recruiting |
NCT06453278 -
(DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
|
||
Not yet recruiting |
NCT05643287 -
The Effect of Time on the Outcome of Periodontal Treatment.
|
N/A |