NCT00641901|Completed
A Study to Evaluate Associations Between Gingivitis and Pregnancy Outcomes
TRIUMPH
A Study of Oral Health Care Education and Therapy to Reduce Gingivitis During Pregnancy
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TRIUMPH
A Study of Oral Health Care Education and Therapy to Reduce Gingivitis During Pregnancy
Sponsor study identifier
observational
120
1 country
1
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)Study Completion
July 2009
Actual (reported)Compelling evidence suggesting a possible link between maternal pregnancy-related periodontitis (gum disease) and spontaneous pre-term birth (PTB)makes effective management of oral health a relevant and significant obstetrical-dental issue. The purpose of this pilot study is to determine whether intensive education and counseling can help pregnant women learn to maintain excellent oral health and in doing so reduce the severity of gingivitis and periodontitis during their pregnancy. Failure to effectively remove the plaque biofilm from the surface of teeth every day is the crucial event leading to the development of gingivitis and plaque-induced gingivitis is the most common form of periodontal disease in pregnant women. We therefore hypothesize that patients can be taught to effectively modulate their own disease through intensive education and meticulous home care coupled with closely monitored behavior modification. We believe this may be an effective approach toward improving oral health with the potential to reduce adverse pregnancy outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
March 17, 2008
Actual (reported)March 24, 2008
Actual (reported)July 2009
Actual (reported)July 2009
Actual (reported)Reduced gingival inflammation
8 weeks
Reduced pre-term birth
40 weeks
Pregnant women with gingivitis
The 8-week study includes 3 visits to the dental facility at the Center for Women's Reproductive Health at UAB. Study visits are scheduled to coincide with pre-natal visits in the same facility. Each visit will include individually tailored one-to-one discussion with a dental professional coupled with a demonstration and instructions for using oral hygiene products. Home-care kits will be dispensed, to include a helpful digital video disk (DVD), a high-tech powered toothbrush, dental floss, toothpaste and alcohol-free mouth rinse and subjects will have their teeth professionally cleaned. First and final visits will include collection of gingival crevicular fluid and blood samples and subjects will complete pre and post study questionnaires.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Center for Women's Reproductive Heath at UAB
The Center for Women's Reproductive Health at UAB
Birmingham, Alabama, 35294, United States
Kramer MS. Determinants of low birth weight: methodological assessment and meta-analysis. Bull World Health Organ. 1987;65(5):663-737.
National Health Statistics. Health, United States, 1982 Washington DC:U S Government Printing Office; December 1982 DHHS publication (PHS) 83-1232
Hamilton BE, Martin JA, Sutton PD; Centers for Disease Control and Prevention, National Center for Health Statistics. Births: preliminary data for 2003. Natl Vital Stat Rep. 2004 Nov 23;53(9):1-17.
Samples of venous blood and gingivial crevicular fluid (GCF)will be collected at baseline and at week-8. GCF samples will be harvested from two non-adjacent oral sites, flash-frozen in liquid nitrogen and stored at -70 degrees F. until batched testing. GCF samples will be analyzed for TNFalpha, IL1beta and IL 6 by Lumidex methodology. Blood samples will be analyzed for Serum Inflammatory markers, C-Reative Protein and inflammatory cytokines.
Michael S Reddy, DMD, DMSc
University of Alabama at Birmingham
120 participants (actual enrollment reported by the registry).
First Submitted
March 17, 2008
First Posted
March 24, 2008
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Quality of Life in Food Allergic Families
Contact the study team to confirm eligibility.
Guyer B, Hoyert DL, Martin JA, Ventura SJ, MacDorman MF, Strobino DM. Annual summary of vital statistics--1998. Pediatrics. 1999 Dec;104(6):1229-46. doi: 10.1542/peds.104.6.1229.
Wienerroither H, Steiner H, Tomaselli J, Lobendanz M, Thun-Hohenstein L. Intrauterine blood flow and long-term intellectual, neurologic, and social development. Obstet Gynecol. 2001 Mar;97(3):449-53. doi: 10.1016/s0029-7844(00)01158-3.
Andrews WW, Hauth JC, Goldenberg RL. Infection and preterm birth. Am J Perinatol. 2000;17(7):357-65. doi: 10.1055/s-2000-13448.
Andrews WW, Goldenberg RL, Hauth JC. Preterm labor: emerging role of genital tract infections. Infect Agents Dis. 1995 Dec;4(4):196-211.
Goldenberg RL, Hauth JC, Andrews WW. Intrauterine infection and preterm delivery. N Engl J Med. 2000 May 18;342(20):1500-7. doi: 10.1056/NEJM200005183422007. No abstract available.
Hauth JC, Andrews WW, Goldenberg RL. Infection-related risk factors predictive of spontaneous birth. Prenat Neonat Med 1998;3:86-90
Goepfert AR, Jeffcoat MK, Andrews WW, Faye-Petersen O, Cliver SP, Goldenberg RL, Hauth JC. Periodontal disease and upper genital tract inflammation in early spontaneous preterm birth. Obstet Gynecol. 2004 Oct;104(4):777-83. doi: 10.1097/01.AOG.0000139836.47777.6d.
Offenbacher S, Katz V, Fertik G, Collins J, Boyd D, Maynor G, McKaig R, Beck J. Periodontal infection as a possible risk factor for preterm low birth weight. J Periodontol. 1996 Oct;67(10 Suppl):1103-13. doi: 10.1902/jop.1996.67.10s.1103.
Jeffcoat MK, Geurs NC, Reddy MS, Cliver SP, Goldenberg RL, Hauth JC. Periodontal infection and preterm birth: results of a prospective study. J Am Dent Assoc. 2001 Jul;132(7):875-80. doi: 10.14219/jada.archive.2001.0299.
LOEE H. PERIODONTAL CHANGES IN PREGNANCY. J Periodontol (1930). 1965 May-Jun;36:209-17. No abstract available.
Arafat AH. Periodontal status during pregnancy. J Periodontol. 1974 Aug;45(8):641-3. doi: 10.1902/jop.1974.45.8.2.641. No abstract available.
Lopez NJ, Smith PC, Gutierrez J. Higher risk of preterm birth and low birth weight in women with periodontal disease. J Dent Res. 2002 Jan;81(1):58-63. doi: 10.1177/002203450208100113.
Lopez NJ, Smith PC, Gutierrez J. Periodontal therapy may reduce the risk of preterm low birth weight in women with periodontal disease: a randomized controlled trial. J Periodontol. 2002 Aug;73(8):911-24. doi: 10.1902/jop.2002.73.8.911.
Hill GB. Preterm birth: associations with genital and possibly oral microflora. Ann Periodontol. 1998 Jul;3(1):222-32. doi: 10.1902/annals.1998.3.1.222.
Gibbs RS. The relationship between infections and adverse pregnancy outcomes: an overview. Ann Periodontol. 2001 Dec;6(1):153-63. doi: 10.1902/annals.2001.6.1.153.
Romero BC, Chiquito CS, Elejalde LE, Bernardoni CB. Relationship between periodontal disease in pregnant women and the nutritional condition of their newborns. J Periodontol. 2002 Oct;73(10):1177-83. doi: 10.1902/jop.2002.73.10.1177.
Lopez NJ, Da Silva I, Ipinza J, Gutierrez J. Periodontal therapy reduces the rate of preterm low birth weight in women with pregnancy-associated gingivitis. J Periodontol. 2005 Nov;76(11 Suppl):2144-53. doi: 10.1902/jop.2005.76.11-S.2144.
Pepys MB, Hirschfield GM. C-reactive protein: a critical update. J Clin Invest. 2003 Jun;111(12):1805-12. doi: 10.1172/JCI18921. No abstract available.
Oppenheim J, Feldman M. Durham S, Hirano T, Vilcek J, Nicola N. Cytokine Reference: A Compendium of cytokines and other mediators of host defense. San Diego, CA Academic Press 2001 (vol 1)
Kaur M, Geisinger ML, Geurs NC, Griffin R, Vassilopoulos PJ, Vermeulen L, Haigh S, Reddy MS. Effect of intensive oral hygiene regimen during pregnancy on periodontal health, cytokine levels, and pregnancy outcomes: a pilot study. J Periodontol. 2014 Dec;85(12):1684-92. doi: 10.1902/jop.2014.140248.
Primary Completion
July 2009
Actual (reported)Study Completion
July 2009
Actual (reported)Last Updated
March 1, 2013
Record last verified: 2013-02
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