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

NCT ID: NCT02333227

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10069 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-01
• Study Completion Date: 2021-12-01

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.

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.

Conditions

Preterm Birth; Periodontal Disease; Caries, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Xylitol

Cluster of sites receiving xylitol gum.

Group Type: EXPERIMENTAL

Xylitol gum

Intervention Type: DIETARY_SUPPLEMENT

This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Kjersti Aagaard

Associate Professor and Vice Chair of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kjersti Aagaard, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

H-35933

Identifier Type: OTHER

Identifier Source: secondary_id

NHSRC # 1030

Identifier Type: -

Identifier Source: org_study_id