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Xylitol and Sorbitol Effects on the Oral Microbiome

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ClinicalTrials.gov Identifier: NCT03668015
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
J. Craig Venter Institute
Information provided by (Responsible Party):
Reisha Rafeek, The University of The West Indies

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, we 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.

Condition or disease Intervention/treatment Phase
Human Microbiome Other: Xylitol then Sorbitol gum Other: Sorbitol then Xylitol gum Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Xylitol and Sorbitol Effects on the Microbiome of Saliva and Plaque
Actual Study Start Date : March 5, 2015
Actual Primary Completion Date : June 4, 2015
Actual Study Completion Date : June 4, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A (Xylitol then sorbitol gum)
Subjects 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
Other: Xylitol then Sorbitol gum
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.

Experimental: Group B (Sorbitol then xylitol gum)
Subjects 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
Other: Sorbitol then Xylitol gum
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.




Primary Outcome Measures :
  1. Oral microbiome composition [ Time Frame: 14 weeks ]
    Profile microbial communities of saliva and plaque based high-throughput sequencing of the 16S rRNA gene.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


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): NCT03668015


Sponsors and Collaborators
The University of The West Indies
J. Craig Venter Institute
Investigators
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Principal Investigator: Reisha Rafeek, MSc, BDS The University of The West Indies
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Responsible Party: Reisha Rafeek, Senior Lecturer, The University of The West Indies
ClinicalTrials.gov Identifier: NCT03668015    
Other Study ID Numbers: CRP.3.MAR14.7
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Reisha Rafeek, The University of The West Indies:
caries
bacteria
saliva
plaque
microbial ecology
Additional relevant MeSH terms:
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Sorbitol
Cathartics
Gastrointestinal Agents