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
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.
調査の概要
詳細な説明
Adverse pregnancy outcomes are significant personal and public health issues in the United States where approximately 12% of all births are pre-term (<37 weeks gestation). Care for these neonates accounts for over 5 million neonatal intensive care hospital stays each year and close to $6 Billion in annual health care costs. Premature delivery and low birth weight (LBW) are leading determinates of neonatal mortality and serious morbidity often leading to neurological and developmental restrictions in early childhood. Concomitant to these data are significant social and psychological consequences related to maternal and family distress and the effects of personal loss.
The role of maternal periodontitis as a potential stressor having detrimental effects on pregnancy outcomes is a relatively new area of investigation. Nevertheless, increasing evidence exists to support an association between maternal periodontal disease, a chronic anaerobic inflammatory condition of the oral cavity, and adverse pregnancy outcomes including pre-term birth (PTB) and fetal growth restriction. This is particularly true with very early-in-gestation delivery.
After adjusting for age, race, smoking and parity, a prospective study of over one-thousand pregnant women conducted at the University of Alabama at Birmingham (UAB) demonstrated that periodontal disease is associated with an increased risk of pre-term birth (PTB) by an odds ratio 4-7, depending on disease severity. These data showed a 55% prevalence of periodontal disease among this cohort; a much higher prevalence than had been reported in national surveys.
The mechanisms responsible for this association remain unclear. However, substantial data suggest that systemic inflammation, as measured by serum C-reactive protein and other inflammatory mediators may well underlie the observed associations.
Investigators hypothesize that links between maternal infections and pre-term bith involve microbes and host response to microbes that enter the uterine cavity during pregnancy. In cases of remote infection, such as periodontitis, this may occur via a blood-bourne route which triggers an alteration in the normal cytokine and hormone regulatory gestation that can result in premature labor, early rupture of membranes and preterm birth.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35294
- The Center for Women's Reproductive Health at UAB
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Confirmed pregnancy between 16 and 24 weeks gestation
- Minimum of 20 natural teeth
- Gingival inflammation 50% of teeth
Exclusion Criteria:
- Multiple gestations
- Positive history for HIV infection, AIDS, Diabetes Mellitus
- Rampant untreated caries
- Concomitant Orthodontic treatment
- Medical condition that requires antibiotic prophylaxis prior to dental treatment
- Chronic use of medication that may cause gingival hypertrophy
- Chronic use of steroids
- Any obstetrical contraindication
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Observation
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Reduced gingival inflammation
時間枠：8 weeks
|
8 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Reduced pre-term birth
時間枠：40 weeks
|
40 weeks
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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. Erratum In: J Clin Invest. 2003 Jul;112(2):299.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Pregnancy-associated Gingivitisの臨床試験
-
Schülke & Mayr GmbH完了