Pregnancy-associated GingivitisTRIUMPHNCT00641901
A Study to Evaluate Associations Between Gingivitis and Pregnancy Outcomes
An observational study of Pregnancy-associated Gingivitis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy-associated Gingivitis
- What is being tested?
- counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The Center for Women's Reproductive Heath at UAB
Who may be able to join
- Confirmed pregnancy between 16 and 24 weeks gestation
- Minimum of 20 natural teeth
- Gingival inflammation 50% of teeth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Women's Reproductive Health at UAB
Birmingham, Alabama, 35294
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Pregnancy-associated Gingivitis
- Being tested
- counseling
- Keywords
- gingivitis, pregnancy, pre-term birth
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counselingBehavioural
Also called Pre and Post-study questionnaires, Instructional DVD, Brushing and flossing instruction, Oral examination
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.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Pregnant women with gingivitis Receives: Behavioral: counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced gingival inflammation
Measured: 8 weeks
Secondary outcomes (1)
Reduced pre-term birth
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startJan 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Pregnancy-associated GingivitisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Reddy, DMD, University of Alabama at Birmingham
- Investigators
- Michael S Reddy, DMD, DMSc, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641901
- Sponsor's protocol ID
- F070117004
- Acronym
- TRIUMPH
- Status last verified
- Feb 2013
- First submitted
- 17 Mar 2008
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kramer MS. Determinants of low birth weight: methodological assessment and meta-analysis. Bull World Health Organ. 1987;65(5):663-737.
PubMed 3322602National 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.
PubMed 15622995Guyer 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.
PubMed 10585972Wienerroither 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.
PubMed 11239655Andrews WW, Hauth JC, Goldenberg RL. Infection and preterm birth. Am J Perinatol. 2000;17(7):357-65. doi: 10.1055/s-2000-13448.
PubMed 12141522Andrews WW, Goldenberg RL, Hauth JC. Preterm labor: emerging role of genital tract infections. Infect Agents Dis. 1995 Dec;4(4):196-211.
PubMed 8665085Goldenberg 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.
PubMed 10816189Hauth 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.
PubMed 15458901Offenbacher 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.
PubMed 8910829Jeffcoat 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.
PubMed 11480640LOEE H. PERIODONTAL CHANGES IN PREGNANCY. J Periodontol (1930). 1965 May-Jun;36:209-17. No abstract available.
PubMed 14300227Arafat 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.
PubMed 4529365Lopez 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.
PubMed 11820369
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Oral Health Care Education and Therapy to Reduce Gingivitis During Pregnancy
- ClinicalTrials.gov ID
- NCT00641901
- Acronym / sponsor ID
- TRIUMPH / F070117004
- Conditions
- Pregnancy-associated Gingivitis
- Keywords
- gingivitis, pregnancy, pre-term birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Behavioral: counselingPregnant women with gingivitis |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Center for Women's Reproductive Heath at UAB
Key inclusion criteria (3 listed)
- Confirmed pregnancy between 16 and 24 weeks gestation
- Minimum of 20 natural teeth
- Gingival inflammation 50% of teeth
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counselingAlso: Pre and Post-study questionnaires, Instructional DVD, Brushing and flossing instruction, Oral examinationThe 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. | Behavioural | Observation |
Primary outcome
Reduced gingival inflammation
Time frame: 8 weeks
1 secondary outcome
Reduced pre-term birth
Time frame: 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
- Background: PubMed 3322602Kramer MS. Determinants of low birth weight: methodological assessment and meta-analysis. Bull World Health Organ. 1987;65(5):663-737.
- BackgroundNational Health Statistics. Health, United States, 1982 Washington DC:U S Government Printing Office; December 1982 DHHS publication (PHS) 83-1232
- Background: PubMed 15622995Hamilton 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.
- Background: PubMed 10585972Guyer 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.
- Background: PubMed 11239655Wienerroither 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.
- Background: PubMed 12141522Andrews WW, Hauth JC, Goldenberg RL. Infection and preterm birth. Am J Perinatol. 2000;17(7):357-65. doi: 10.1055/s-2000-13448.
- Background: PubMed 8665085Andrews WW, Goldenberg RL, Hauth JC. Preterm labor: emerging role of genital tract infections. Infect Agents Dis. 1995 Dec;4(4):196-211.
- Background: PubMed 10816189Goldenberg 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.
- BackgroundHauth JC, Andrews WW, Goldenberg RL. Infection-related risk factors predictive of spontaneous birth. Prenat Neonat Med 1998;3:86-90
- Background: PubMed 15458901Goepfert 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.
- Background: PubMed 8910829Offenbacher 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.
- Background: PubMed 11480640Jeffcoat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Reddy, DMD, DMSc principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy-associated Gingivitis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced gingival inflammation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00641901, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.