Delivery of Polyphenols in Gum as an Anti-Caries Agent

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Chewing gum containing xylitol and blackberry extract (BBE)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study was a randomized, crossover-washout design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Half the participants receiving placebo gum (2 gram; 1 gram xylitol) first, | Other: Chewing gum containing xylitol and blackberry extract (BBE)<br>* On the day of gum chewing, four pieces of gum were provided per the assigned group, and each volunteer was requested to chew the gum four times daily (i.e., at 9 am, 11 am, 1 pm and 3 pm). Each gum chewing interval was for 20 minutes.<br>|
| Experimental: BBE gum<br>Half receiving first the BBE gum (2 gram; 1 gram xylitol and 100 mg BBE) that were identical in size, shape, color and flavor. After 1 week the groups cross-over and chewed the other gum. | Other: Chewing gum containing xylitol and blackberry extract (BBE)<br>* On the day of gum chewing, four pieces of gum were provided per the assigned group, and each volunteer was requested to chew the gum four times daily (i.e., at 9 am, 11 am, 1 pm and 3 pm). Each gum chewing interval was for 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total salivary bacteria count | Comparative difference in the total salivary bacteria count after chewing 4 pieces of gum | 7 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteria count on enamel | Comparative difference in the total bacteria count after chewing 4 pieces of gum (placebo vs. BBE gum) | 7 hours |