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

Primary Purpose

Dental Caries

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Chewing gum containing xylitol and blackberry extract (BBE)

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

BBE gum

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Total salivary bacteria count

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

Secondary Outcome Measures

Bacteria count on enamel

Comparative difference in the total bacteria count after chewing 4 pieces of gum (placebo vs. BBE gum)

Full Information

NCT ID

NCT05133557

First Posted

November 12, 2021

Last Updated

November 12, 2021

Sponsor

Craig Miller

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

1. Study Identification

Unique Protocol Identification Number

NCT05133557

Brief Title

Delivery of Polyphenols in Gum as an Anti-Caries Agent

Acronym

BBE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 1, 2012 (Actual)

Primary Completion Date

November 30, 2015 (Actual)

Study Completion Date

November 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Craig Miller

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This study was a randomized, crossover-washout design.

Masking

ParticipantCare ProviderInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

BBE gum

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Chewing gum containing xylitol and blackberry extract (BBE)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Total salivary bacteria count

Description

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

Time Frame

7 hours

Secondary Outcome Measure Information:

Title

Bacteria count on enamel

Description

Comparative difference in the total bacteria count after chewing 4 pieces of gum (placebo vs. BBE gum)

Time Frame

7 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig S Miller, DMD, MS

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

12804021

Citation

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.

Results Reference

background

PubMed Identifier

21827957

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.

Results Reference

background

PubMed Identifier

17651061

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. doi: 10.1089/jmf.2006.238.

Results Reference

background

PubMed Identifier

30429438

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.

Results Reference

background

Links:

URL

https://ukhealthcare.uky.edu/doctors/craig-miller

Description

UK Healthcare website

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Delivery of Polyphenols in Gum as an Anti-Caries Agent

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