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Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi (PPaX)

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ClinicalTrials.gov Identifier: NCT02333227
Recruitment Status : Recruiting
First Posted : January 7, 2015
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Kjersti Aagaard, Baylor College of Medicine

Brief Summary:
The hypothesis of the investigators' project is that comprehensive primary preterm birth prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention), will reduce the rate of periodontal disease and caries, preterm birth prevalence, and neonatal mortality.

Condition or disease Intervention/treatment Phase
Preterm Birth Periodontal Disease Caries, Dental Dietary Supplement: Xylitol gum Not Applicable

Detailed Description:

Significance and Impact: Adverse birth outcomes related to the length of gestation (preterm birth) are recognized as one of the most significant disorders in maternal-child health at a global scale. In the developed world, the preterm birth rate approximates 7%. In Malawi, the investigators have recently demonstrated that this rate more than triples to approximate 26.1%. Of the 4 million newborn deaths annually, nearly 1/3 (27%) are directly attributable to prematurity with another 36% secondary to related opportunistic infections (sepsis, pneumonia, gastrointestinal). 75% of the 4 million deaths occur within the first week of life, with the vast majority occurring in the first 48 hours. For those that do survive, there are persistent and lifelong risks due to stunted growth, chronic infection, retinopathy of prematurity, and bronchopulmonary dysplasia. The link between maternal oral health (periodontal disease in particular) and risk of preterm birth has been demonstrated across all populations (rural and urban, in both industrialized and developing regions) studied to date. However, in multiple randomized controlled trials treatment of active periodontal disease with scaling and planning during pregnancy has failed to demonstrate a significant benefit in preventing preterm birth.

Why would maternal oral health impact preterm birth? In rodents, subcutaneous inoculations with periodontal pathogens cause dose-dependent decreases in pup weights, and elicit inflammatory responses that can trigger preterm birth when present in amniotic fluid. Periodontitis (defined as a destructive inflammation of the periodontium) has a prevalence of 30% or greater in women of child bearing age. By definition, it involves microbial infiltration of the periodontium, which stimulates a chronic inflammatory response, recurrent bacteremia, and the production of cytokines and prostaglandins which trigger risk of preterm birth. It is the same production of prostaglandins which are felt to mediate the risk of preterm birth. So if the investigators know that there is biologic evidence that periodontitis is related to preterm birth, but treating active periodontitis does not reduce these morbidities, is it possible that preventing periodontitis might prevent preterm birth and low birth weight? If so, what are the least expensive efficacious preventative measures? The investigators' overarching hypothesis is that comprehensive primary preterm birth prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention), will reduce the rate of periodontal disease and caries, preterm birth prevalence, and neonatal mortality.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9365 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi (Prevention of Prematurity and Xylitol)
Study Start Date : May 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
Drug Information available for: Xylitol

Arm Intervention/treatment
No Intervention: Control
Cluster of sites not receiving xylitol gum. This is a cluster randomized trial, whereby 4 sites will not receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
Experimental: Xylitol
Cluster of sites receiving xylitol gum.
Dietary Supplement: Xylitol gum
This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.




Primary Outcome Measures :
  1. Rate of preterm birth [ Time Frame: Conception to date of delivery, <37 weeks gestation ]
    Measure rate of preterm birth <37 and <34 weeks gestation, as defined by best obstetrical estimate of last menstrual period consistent with <24 week sonogram, OR <24 week sonogram with unknown last menstrual period, OR skilled examination and <24 week sonogram.

  2. Number of infants <2000 grams [ Time Frame: Date of delivery to 1 week postnatal ]
    Measured weight at delivery to determine the rate of <2000 gram infants.

  3. Number of infants with adverse neonatal composite morbidity and mortality [ Time Frame: Date of delivery to 30 days postnatal ]
    Additive or singular composite neonatal morbidity of <2000 gram infants at 30 days of age. Composite neonatal morbidity and mortality outcomes are defined as: neonatal death, neonatal sepsis, neonatal respiratory distress requiring assisted ventilation (generally bubble CPAP in this region of Malawi), exogenous oxygen, necrotizing enterocolitis, and neonatal seizures.


Secondary Outcome Measures :
  1. Prevalence of periodontal disease [ Time Frame: Enrollment up to 5 years ]
    We will measure the prevalence of periodontal disease among gravidae. We will use now standardized WHO oral health forms and disease scoring.

  2. Prevalence of dental caries [ Time Frame: Enrollment up to 5 years ]
    We will measure the prevalence of dental caries among gravidae. We will use now standardized WHO oral health forms and disease scoring.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Enrollment at <20 weeks gestation by best obstetrical estimate, or
  2. Enrollment post partum with an anticipated next pregnancy within 18 months, or
  3. Enrollment preconception with an anticipated pregnancy within 18 months (preconception); and
  4. Cognitively aware enough to participate in the study
  5. >18 years of age (in Malawi, constitutes a legal adult and capacity to consent for study)
  6. Willing to participate in the study
  7. Willing to undergo at least two periodontal exams
  8. Willing to chew 1 piece of xylitol gum for 10 minutes after the morning and evening meal (intervention sites)
  9. Anticipating to remain within the region for 18 months

Exclusion Criteria:

  1. >20 weeks gestation by best obstetrical estimate
  2. Post partum and not anticipating another pregnancy within 18 months
  3. Preconception and not anticipating another pregnancy within 18 months
  4. Not cognitively aware enough to participate in the study
  5. Not willing to undergo at least two periodontal exams
  6. <18 years of age
  7. Not willing to chew 1 piece of xylitol gum for 10 minutes after the morning and evening meal (intervention sites)
  8. Anticipating a move outside of the region within 18 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333227


Contacts
Contact: Kjersti Aagaard, M.D. 713 798-8467 aagaardt@bcm.tmc.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Kjersti Aagaard, MD/PhD    713-798-8467    aagaardt@bcm.edu   
Contact: Brigid Boggan, BS    713-798-8701    boggan@bcm.edu   
Sub-Investigator: Brigid D Boggan, BS         
Principal Investigator: Kjersti Aagaard, MD/PhD         
Sub-Investigator: Kathleen Antony, MD         
Sub-Investigator: Raine Susan, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Kjersti Aagaard, M.D. Baylor College of Medicine

Responsible Party: Kjersti Aagaard, Associate Professor and Vice Chair of Research, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02333227     History of Changes
Other Study ID Numbers: NHSRC # 1030
H-35933 ( Other Identifier: Baylor College of Medicine )
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Premature Birth
Dental Caries
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Tooth Demineralization