Delivery of Polyphenols in Gum as an Anti-Caries Agent (BBE)

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Other: Chewing gum containing xylitol and blackberry extract (BBE)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Half the participants receiving placebo gum (2 gram; 1 gram xylitol) first,	Other: Chewing gum containing xylitol and blackberry extract (BBE); 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.
Experimental: BBE gum; 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); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Craig Miller
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Craig S Miller, DMD, MS, University of Kentucky

Publications and helpful links

General Publications

• Cavanagh HM, Hipwell M, Wilkinson JM. Antibacterial activity of berry fruits used for culinary purposes. J Med Food. 2003 Spring;6(1):57-61. doi: 10.1089/109662003765184750.
• Danaher RJ, Wang C, Dai J, Mumper RJ, Miller CS. Antiviral effects of blackberry extract against herpes simplex virus type 1. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Sep;112(3):e31-5. doi: 10.1016/j.tripleo.2011.04.007.
• Dai J, Patel JD, Mumper RJ. Characterization of blackberry extract and its antiproliferative and anti-inflammatory properties. J Med Food. 2007 Jun;10(2):258-65. doi: 10.1089/jmf.2006.238.
• Takeuchi K, Asakawa M, Hashiba T, Takeshita T, Saeki Y, Yamashita Y. Effects of xylitol-containing chewing gum on the oral microbiota. J Oral Sci. 2018 Dec 27;60(4):588-594. doi: 10.2334/josnusd.17-0446. Epub 2018 Nov 15.

Helpful Links

• UK Healthcare website

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2015

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 12-0704-F6A; R42DE018839 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No