Dental CariesBBENCT05133557
Delivery of Polyphenols in Gum as an Anti-Caries Agent
A study testing Chewing gum containing xylitol and blackberry extract (BBE) in people with Dental Caries, run by Craig Miller.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Chewing gum containing xylitol and blackberry extract (BBE)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2012to 30 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Chewing gum containing xylitol and blackberry extract (BBE)
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Half the participants receiving placebo gum (2 gram; 1 gram xylitol) first, Receives: 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. Receives: Other: Chewing gum containing xylitol and blackberry extract (BBE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total salivary bacteria count
Comparative difference in the total salivary bacteria count after chewing 4 pieces of gum
Measured: 7 hours
Secondary outcomes (1)
Bacteria count on enamel
Comparative difference in the total bacteria count after chewing 4 pieces of gum (placebo vs. BBE gum)
Measured: 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Oct 2012
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study was a randomized, crossover-washout design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Miller
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor-investigator, Craig Miller, University of Kentucky
- Investigators
- Craig S Miller, DMD, MS, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133557
- Sponsor's protocol ID
- 12-0704-F6A
- Other IDs
- R42DE018839
- Acronym
- BBE
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 12804021Danaher 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.
PubMed 21827957Dai 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.
PubMed 17651061Takeuchi 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.
PubMed 30429438
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chewing Gum Containing Xylitol and Blackberry Extract on Oral Microbiota
- ClinicalTrials.gov ID
- NCT05133557
- Acronym / sponsor ID
- BBE / 12-0704-F6A
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Craig MillerUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study was a randomized, crossover-washout design.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Chewing gum containing xylitol and blackberry extract (BBE)Half the participants receiving placebo gum (2 gram; 1 gram xylitol) first, |
| BBE gum | Experimental | Other: Chewing gum containing xylitol and blackberry extract (BBE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | BBE gum, Placebo |
Primary outcome
Total salivary bacteria count
Time frame: 7 hours
Comparative difference in the total salivary bacteria count after chewing 4 pieces of gum
1 secondary outcome
Bacteria count on enamel
Time frame: 7 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Background: PubMed 12804021Cavanagh 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.
- Background: PubMed 21827957Danaher 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.
- Background: PubMed 17651061Dai 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.
- Background: PubMed 30429438Takeuchi 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.
- UK Healthcare websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig S Miller, DMD, MS principal investigator
University of Kentucky
Questions about this trial
What is this clinical trial studying?
A study testing Chewing gum containing xylitol and blackberry extract (BBE) in people with Dental Caries, run by Craig Miller.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total salivary bacteria count (time frame: 7 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05133557, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.