Delivery of Polyphenols in Gum as an Anti-Caries Agent

NCT05133557 | Completed

• 2 other identifiers: 12-0704-F6AR42DE018839
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Total salivary bacteria count

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

  7 hours

Secondary Outcomes (1)

• Bacteria count on enamel

  7 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Half the participants receiving placebo gum (2 gram; 1 gram xylitol) first,

Other: Chewing gum containing xylitol and blackberry extract (BBE)

BBE gum

EXPERIMENTAL

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)

Interventions

Chewing gum containing xylitol and blackberry extract (BBE) OTHER

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.

BBE gum; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Craig Miller: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Related 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. doi: 10.1089/109662003765184750.

  PMID: 12804021 BACKGROUND

• 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.

  PMID: 21827957 BACKGROUND

• 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.

  PMID: 17651061 BACKGROUND

• 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.

  PMID: 30429438 BACKGROUND

Related Links

• UK Healthcare website

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Craig S Miller, DMD, MS

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Each volunteer was allocated xylitol-containing placebo gum or xylitol-containing BBE gum according to a predetermined randomization scheme. To ensure investigator blinding, test products were dispensed through other staff members who kept the assignment codes in sealed envelopes. Randomization resulted in half the participants receiving placebo gum (2 gram; 1 gram xylitol) first, and half receiving first the BBE gum (2 gram; 1 gram xylitol and 100 mg BBE) that were identical in size, shape, color and flavor.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This study was a randomized, crossover-washout design.

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: October 1, 2012
• Primary Completion: November 30, 2015
• Study Completion: November 30, 2015
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share