N/A
N=10,069
Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi
Preterm Birth · Periodontal Disease · Caries, Dental
Bottom Line
View on ClinicalTrials.gov: NCT02333227 ↗Enrolled (actual)
10,069
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Rate of Preterm Birth — 878; 549 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Xylitol gum (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Baylor College of Medicine
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Preterm Birth |
878; 549 | <0.05 sig |
| PRIMARY Number of Infants <2500 Grams |
679; 385 | <0.05 sig |
| SECONDARY Number of Infants With Adverse Neonatal Composite Morbidity and Mortality |
238; 133 | <0.05 sig |
| SECONDARY Number of Participants With Periodontal Disease |
117; 102 | <0.05 sig |
| SECONDARY Number of Participants With Dental Caries |
123; 135 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Enrollment at 18 years of age (in Malawi, constitutes a legal adult and capacity to consent for study)
- Willing to participate in the study
- Willing to undergo at least two periodontal exams
- Willing to chew 1 piece of xylitol gum for 10 minutes after the morning and evening meal (intervention sites)
- Anticipating to remain within the region for 18 months
Exclusion Criteria
- >20 weeks gestation by best obstetrical estimate
- Post partum and not anticipating another pregnancy within 18 months
- Preconception and not anticipating another pregnancy within 18 months
- Not cognitively aware enough to participate in the study
- Not willing to undergo at least two periodontal exams
- <18 years of age
- Not willing to chew 1 piece of xylitol gum for 10 minutes after the morning and evening meal (intervention sites)
- Anticipating a move outside of the region within 18 months
Data sourced from ClinicalTrials.gov (NCT02333227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.