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Clinical Trials/NCT05133557
NCT05133557
Completed
Not Applicable

Effects of Chewing Gum Containing Xylitol and Blackberry Extract on Oral Microbiota

Craig Miller0 sites50 target enrollmentOctober 1, 2012
ConditionsDental Caries

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries
Sponsor
Craig Miller
Enrollment
50
Primary Endpoint
Total salivary bacteria count
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The short-term effects of chewing gum containing xylitol and/or blackberry extract on oral microbiota was studied. Fifty healthy adults participated in a randomized, placebo-controlled, cross-over design study.

Detailed Description

The short-term effects of chewing gum containing xylitol and/or blackberry extract on oral microbiota was studied. Fifty healthy adults participated in a randomized, placebo-controlled, cross-over design study. One group chewed 1 piece of xylitol-containing chewing gum 4 times/day and the other chewed 1 piece of BBE+xylitol-containing gum 4 times/day. All wore a custom stent with a sterile enamel chip luted to the facial surface during the 1-day experiment. Unstimulated saliva was collected at 8 am and 4 pm, and enamel chips were harvested at 4 pm. A week later participants chewed gum from the other group. The bacterial composition in saliva and on the enamel chips were assessed using real-time PCR.

Registry
clinicaltrials.gov
Start Date
October 1, 2012
End Date
November 30, 2015
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Craig Miller
Responsible Party
Sponsor Investigator
Principal Investigator

Craig Miller

Professor

University of Kentucky

Eligibility Criteria

Inclusion Criteria

  • systemically healthy, had 20 or more natural erupted teeth, and had gingivitis (bleeding on probing \[BOP\] in more than 15% of sites, less than 25% sites with \> 4 mm probing pocket depths (PPD), and less than 5% sites with 5 mm depth PPD, who were a non-smoker, willing to participate, and verbally understood and signed an informed consent prior to enrollment

Exclusion Criteria

  • unable or unwilling to provide informed consent or follow study protocol, current smoker, systemic condition including diabetes mellitus, liver disease, kidney disease, autoimmune disease, and any cardiovascular condition that would require premedication prior to dental treatment, use of systemic antibiotics within three months of study entry, use of over the counter or prescription medications known to have anti-inflammatory/immunosuppressant activities (e.g., nonsteroidal anti-inflammatory drugs (\>14 day use in past 3 months), steroids, vitamin supplements, statin drugs, topical chlorhexidine on a daily basis, pregnancy as diagnosed by administered of a pregnancy test, cancer or cancer therapy within the last year, immunosuppression (e.g., organ transplant), orthodontic therapy (current or within the last 6 months), inability to communicate verbally or in writing, clinically detectable oral mucosal inflammatory condition (e.g., aphthous, lichen planus, leukoplakia, oral cancer), or febrile illness, persistent cough or current infectious condition (e.g., influenza, hepatitis), or any PPD of 6 mm or greater at the time of the baseline periodontal examination.

Outcomes

Primary Outcomes

Total salivary bacteria count

Time Frame: 7 hours

Comparative difference in the total salivary bacteria count after chewing 4 pieces of gum

Secondary Outcomes

  • Bacteria count on enamel(7 hours)

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