Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2024-06-13
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Xylitol gum
Participants will receive 6.36grams of daily xylitol; Epic dental gum, 1.06 grams Xylitol per piece of gum; to chew two pieces for 5 minutes after meals, thrice a day.
Xylitol gum
Two pieces of xylitol gum after meals, thrice a day.
Sorbitol gum
Participants will receive Epic sorbitol-containing gum (0 grams xylitol/day); to chew two pieces for 5 minutes after meals, thrice a day.
Sorbitol gum
Two pieces of sorbitol gum after meals, thrice a day.
Interventions
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Xylitol gum
Two pieces of xylitol gum after meals, thrice a day.
Sorbitol gum
Two pieces of sorbitol gum after meals, thrice a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A singleton at \<20 weeks' gestation (based on ultrasound or best obstetric measurement)
* Planning to deliver at Area 25 health center.
* Willing to chew two pieces of gum thrice daily for 5 minutes after the morning, day and evening meals throughout pregnancy.
* Willing to undergo at least two dental exams including oral microbiota sampling at study enrolment \<20 weeks of pregnancy, 28-30 weeks, at delivery/within 48 hours and 4-6 weeks after giving birth.
* Willing to have at least two vaginal sampling at study enrolment \<20 weeks of pregnancy, 28-30 weeks, at delivery/within 48 hours and 4-6 weeks after giving birth.
* Able to speak Chichewa or English.
* Cognitively aware enough to be able to participate in the study.
* Willing to consent to all required aspects of protocol including allowing collection of placenta specimens, infant oral swab and meconium/stool sampling at birth/within 48 hours and 4-6 weeks after.
Exclusion Criteria
* Gravidae with known or suspected non-viable pregnancy (including life threatening congenital anomalies such as cardiac, neurological or others).
* Pregnant individual has a life-threatening diagnosis such as cancer requiring treatment during pregnancy.
* Pregnant women with a known or suspected morbidly adherent placenta (such as placenta accrete, increta and percreta).
12 Years
60 Years
FEMALE
No
Sponsors
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Fogarty International Center of the National Institute of Health
NIH
University of Washington
OTHER
Baylor College of Medicine Children's Foundation Malawi
UNKNOWN
Baylor College of Medicine
OTHER
Responsible Party
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Benjamin Chimarioff Shayo
Assistant Professor
Principal Investigators
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Benjamin Shayo, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Area 25 Health Center
Lilongwe, , Malawi
Countries
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References
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Chen P, Hong F, Yu X. Prevalence of periodontal disease in pregnancy: A systematic review and meta-analysis. J Dent. 2022 Oct;125:104253. doi: 10.1016/j.jdent.2022.104253. Epub 2022 Aug 20.
Robinson JL, Johnson PM, Kister K, Yin MT, Chen J, Wadhwa S. Estrogen signaling impacts temporomandibular joint and periodontal disease pathology. Odontology. 2020 Apr;108(2):153-165. doi: 10.1007/s10266-019-00439-1. Epub 2019 Jul 3.
Alnasser BH, Alkhaldi NK, Alghamdi WK, Alghamdi FT. The Potential Association Between Periodontal Diseases and Adverse Pregnancy Outcomes in Pregnant Women: A Systematic Review of Randomized Clinical Trials. Cureus. 2023 Jan 1;15(1):e33216. doi: 10.7759/cureus.33216. eCollection 2023 Jan.
Bobetsis YA, Graziani F, Gursoy M, Madianos PN. Periodontal disease and adverse pregnancy outcomes. Periodontol 2000. 2020 Jun;83(1):154-174. doi: 10.1111/prd.12294.
Zhang Y, Feng W, Li J, Cui L, Chen ZJ. Periodontal Disease and Adverse Neonatal Outcomes: A Systematic Review and Meta-Analysis. Front Pediatr. 2022 May 4;10:799740. doi: 10.3389/fped.2022.799740. eCollection 2022.
Iheozor-Ejiofor Z, Middleton P, Esposito M, Glenny AM. Treating periodontal disease for preventing adverse birth outcomes in pregnant women. Cochrane Database Syst Rev. 2017 Jun 12;6(6):CD005297. doi: 10.1002/14651858.CD005297.pub3.
Soderling E, Pienihakkinen K. Effects of xylitol and erythritol consumption on mutans streptococci and the oral microbiota: a systematic review. Acta Odontol Scand. 2020 Nov;78(8):599-608. doi: 10.1080/00016357.2020.1788721. Epub 2020 Jul 7.
Marghalani AA, Guinto E, Phan M, Dhar V, Tinanoff N. Effectiveness of Xylitol in Reducing Dental Caries in Children. Pediatr Dent. 2017 Mar 15;39(2):103-110.
Gudnadottir U, Debelius JW, Du J, Hugerth LW, Danielsson H, Schuppe-Koistinen I, Fransson E, Brusselaers N. The vaginal microbiome and the risk of preterm birth: a systematic review and network meta-analysis. Sci Rep. 2022 May 13;12(1):7926. doi: 10.1038/s41598-022-12007-9.
Loimaranta V, Mazurel D, Deng D, Soderling E. Xylitol and erythritol inhibit real-time biofilm formation of Streptococcus mutans. BMC Microbiol. 2020 Jun 29;20(1):184. doi: 10.1186/s12866-020-01867-8.
Soderling E, Pienihakkinen K, Gursoy UK. Effects of sugar-free polyol chewing gums on gingival inflammation: a systematic review. Clin Oral Investig. 2022 Dec;26(12):6881-6891. doi: 10.1007/s00784-022-04729-x. Epub 2022 Oct 14.
Soderling E, Pienihakkinen K. Effects of xylitol chewing gum and candies on the accumulation of dental plaque: a systematic review. Clin Oral Investig. 2022 Jan;26(1):119-129. doi: 10.1007/s00784-021-04225-8. Epub 2021 Oct 22.
Other Identifiers
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H-55146
Identifier Type: -
Identifier Source: org_study_id
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