Delivery of Polyphenols in Gum as an Anti-Caries Agent

Dental Caries Clinical Trial

— BBE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05133557
• Other study ID #: 12-0704-F6A
• Secondary ID: R42DE018839
• Status: Completed
• Phase: N/A
• Start date: October 1, 2012
• Est. completion date: November 30, 2015

Study information

• Verified date: November 2021
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2015
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Craig Miller	National Institute of Dental and Craniofacial Research (NIDCR)

References & Publications (4)

Cavanagh HM, Hipwell M, Wilkinson JM. Antibacterial activity of berry fruits used for culinary purposes. J Med Food. 2003 Spring;6(1):57-61. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total salivary bacteria count	Comparative difference in the total salivary bacteria count after chewing 4 pieces of gum	7 hours
Secondary	Bacteria count on enamel	Comparative difference in the total bacteria count after chewing 4 pieces of gum (placebo vs. BBE gum)	7 hours

External Links

•   UK Healthcare website