Xylitol and Sorbitol Effects on the Oral Microbiome
1 other identifier
interventional
29
0 countries
N/A
Brief Summary
Chewing gum containing xylitol may help prevent caries by reducing levels of mutans streptococci (MS) and lactobacilli in saliva and plaque. Very little is known about other species which are possibly beneficial to oral health. In this study, the investigators employed high-throughput sequencing of the 16S ribosomal ribonucleic acid (rRNA) gene to profile microbial communities of saliva and plaque following short-term consumption of xylitol and sorbitol containing chewing gum. Participants (n = 30) underwent a washout period and were randomly assigned to one of two groups. Each group chewed either xylitol or sorbitol gum for 3 weeks, before undergoing a second four-week washout period after which they switched to the alternate gum for three weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2015
CompletedFirst Submitted
Initial submission to the registry
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedOctober 5, 2021
September 1, 2021
3 months
September 10, 2018
September 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oral microbiome composition
Profile microbial communities of saliva and plaque based high-throughput sequencing of the 16S rRNA gene.
14 weeks
Study Arms (2)
Group A (Xylitol then sorbitol gum)
EXPERIMENTALSubjects were randomly allocated to a group and entered a 4-week "washout period" during which no gum was chewed, followed by a 3-week treatment period (treatment period 1) during which Group A used Xylitol gum.(2 gum pieces, 3 times daily after meals for 6 minutes).Then underwent another 4-week washout period before entering treatment period 2 during which Group A used Gum Sorbitol
Group B (Sorbitol then xylitol gum)
EXPERIMENTALSubjects were randomly allocated to a group and entered a 4-week "washout period" during which no gum was chewed, followed by a 3-week treatment period (treatment period 1) during which Group B used sorbitol gum. Group B used Gum Sorbitol (2 gum pieces, 3 times daily after meals for 6 minutes).Then underwent another 4-week washout period before entering treatment period 2 during which Group B used Gum xylitol
Interventions
Xylitol gum contains 70% xylitol in addition to gum base, natural flavors, soy lecithin, gum arabic, titanium dioxide, carnuba wax. Sorbitol gum was similar except that xylitol was replaced by 63% sorbitol and 2% maltitol and aspartame was included.
Sorbitol gum was similar except that xylitol was replaced by 63% sorbitol and 2% maltitol and aspartame was included. Xylitol gum contains 70% xylitol in addition to gum base, natural flavors, soy lecithin, gum arabic, titanium dioxide, carnuba wax.
Eligibility Criteria
You may qualify if:
- To be eligible, subjects must have been 18 years and over, have had at least 20 teeth, provided written informed consent and been willing to comply with study procedures
You may not qualify if:
- Subjects with systemic, infectious or inflammatory diseases or taking medicines, antibiotics or fluoride in the last month, habitual consumers of xylitol / sorbitol-containing products and mouth rinses, with abnormal salivary flow (\<1ml / min), pregnant, on contraceptive pills, or with abnormal dietary habits were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of The West Indieslead
- J. Craig Venter Institutecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reisha Rafeek, MSc, BDS
The University of The West Indies
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 12, 2018
Study Start
March 5, 2015
Primary Completion
June 4, 2015
Study Completion
June 4, 2015
Last Updated
October 5, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share