NCT03668015

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2015

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 10, 2018

Last Update Submit

September 27, 2021

Conditions

Keywords

cariesbacteriasalivaplaquemicrobial ecology

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)

EXPERIMENTAL

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

Group B (Sorbitol then xylitol gum)

EXPERIMENTAL

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

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.

Group A (Xylitol then sorbitol 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.

Group B (Sorbitol then xylitol gum)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Reisha Rafeek, MSc, BDS

    The University of The West Indies

    PRINCIPAL INVESTIGATOR

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