GingivitisNCT03237624
Functional Chewing Gum in Reduction of Gingival Inflammation
A study testing Functional Chitosan Chewing Gum and Oral hygiene measures in people with Gingivitis, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The aim of this prospective randomized 3-month double-blinded single center study is to determine whether a chewing gum device with food additive chitosan, will aid in reducing gingival inflammation by supplementing traditional tooth brushing and flossing measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis
- What is being tested?
- Functional Chitosan Chewing Gum and Oral hygiene measures
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 31 Jan 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild-moderate gingivitis
- Minimum of 20 natural teeth
Who cannot join
- Significant alveolar bone loss as evidenced by Bite-wings (>3.0 mm cementoenamel junction to bone)
- Requirement for antibiotic pre-medication prior to dental procedures
- Systemic antibiotic use in past 14 days to current.
- Use of oral contraceptives
- Use of anti-inflammatory (NSAIDs) or in past 14 days.
- Use of anticoagulant therapy or in past 14 days.
Show all 10Show fewer
- Poorly controlled diabetes (HbA1c > 7.9%)*
- Smoking
- Pregnancy
- Use of any oral rinses such as, but not limited to chlorhexidine, essential oils, cetylpyridinium chloride during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Dentistry
Baltimore, Maryland, 21201
About this study
Official title: Use of a Functional Chewing Gum in Reduction of Gingival Inflammation
The aim of this prospective randomized 3-month double-blinded single center study is to determine whether a chewing gum device with food additive chitosan, will aid in reducing gingival inflammation by supplementing traditional tooth brushing and flossing measures. Patients with mild to moderate gingivitis will be identified and enrolled in this investigation. All enrolled subjects will receive baseline oral hygiene brushing instructions and a baseline clinical examination of the gingiva. The test group will utilize the test chewing gum three times a day for a minimum 20-30 minutes duration; the control group will receive a placebo gum and use it in a similar manner. We will examine whether daily use of a functional chewing gum enhances improvements to brushing and flossing.
Read the detailed description
Periodontal disease remains a prevalent and preventable disease in man. Plaque bacterial biofilm remains the primary etiologic agent of disease; colonization of non-shedding tooth surfaces greatly contributes to initiation and progression of gingivitis, for example. Although there are currently available chemotherapeutic agents to supplement daily oral hygiene measures, one continuous issue is patient compliance. Chewing gum represents a unique delivery device for not only drugs and other agents, but food additives that might aid in reducing bacteria plaque colonization on tooth surfaces. For example, chitosan and chitosan-related food additive preparations have been shown to have some antimicrobial-like properties, possibly in the disruption of bacterial colonization (not -cidal).
NOTE: ALL INGREDIENTS of the "test" chewing gum, and the placebo chewing gum, are generally regarded as safe ("GRAS" label by the Food and Drug Administration), as they are common food components. For example, chitosan is listed in the GRAS database (https://www.accessdata.fda.gov/scripts/fdcc/?set=SCOGS). See item GRN No. 397.
This study aims to determine whether adjunctive use of functional chewing gum will improve gingival inflammation status-retaining clinical gains initiated by professional tooth cleaning and at home brushing over a 12 week period in gingivitis patients.
Eligibility criteria and outcome measures are described in the next section.
- Conditions
- Gingivitis
- Being tested
- Functional Chitosan Chewing Gum, Control Chewing Gum, Oral hygiene measures
- Keywords
- gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Chitosan Chewing GumDevice
Chitosan and chitosan-related preparations have been shown to have some antimicrobial properties, possibly in the disruption of bacterial colonization. It is thought that as a component of a functional chewing gum this will supplement in the removal of daily build up of dental plaque on tooth surfaces.
Control Chewing GumDevice
Control chewing gum device does not have food additive chitosan in its composition.
Oral hygiene measuresBehavioural
Patients will be given instructions on how to brush and floss routinely (twice per day)
| Study group | Role | What they receive |
|---|---|---|
| Functional chewing gum | Experimental | Subjects given as intervention functional chewing gum device to supplement oral hygiene practices. Functional gum contains chitosan which is a food additive or generally recognized as safe food product. Individuals will use this gum 20 to 30 minutes three times per day. Subjects will brush and floss normally twice a day. Receives: Device: Functional Chitosan Chewing Gum; Behavioral: Oral hygiene measures |
| Control chewing gum | Placebo comparator | Subjects given control gum to supplement oral hygiene practices. Placebo gum does not contain any active ingredients. Individuals will use this gum 20 to 30 minutes three times per day. Subjects will brush and floss normally twice a day. Receives: Device: Control Chewing Gum; Behavioral: Oral hygiene measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gum inflammation change
Measure the color of gingiva - use Gingiva Index
Measured: Change in color of gingiva from baseline to 12 weeks
Secondary outcomes (1)
Plaque levels (on teeth) change
Measure plaque using Plaque Index
Measured: Change in plaque level from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start31 Jan 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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 GingivitisStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harlan Shiau, University of Maryland, Baltimore
- Investigators
- Harlan Shiau, DDS, Principal investigator, UMSOD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237624
- Sponsor's protocol ID
- HP-00073354
- Status last verified
- Nov 2024
- First submitted
- 31 Jul 2017
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaur S, Dhillon GS. The versatile biopolymer chitosan: potential sources, evaluation of extraction methods and applications. Crit Rev Microbiol. 2014 May;40(2):155-75. doi: 10.3109/1040841X.2013.770385. Epub 2013 Mar 14.
PubMed 23488873Machul A, Mikolajczyk D, Regiel-Futyra A, Heczko PB, Strus M, Arruebo M, Stochel G, Kyziol A. Study on inhibitory activity of chitosan-based materials against biofilm producing Pseudomonas aeruginosa strains. J Biomater Appl. 2015 Sep;30(3):269-78. doi: 10.1177/0885328215578781. Epub 2015 Apr 8.
PubMed 25855683Li Y, Lee S, Hujoel P, Su M, Zhang W, Kim J, Zhang YP, DeVizio W. Prevalence and severity of gingivitis in American adults. Am J Dent. 2010 Feb;23(1):9-13.
PubMed 20437720Simons D, Beighton D, Kidd EA, Collier FI. The effect of xylitol and chlorhexidine acetate/xylitol chewing gums on plaque accumulation and gingival inflammation. J Clin Periodontol. 1999 Jun;26(6):388-91. doi: 10.1034/j.1600-051x.1999.260609.x.
PubMed 10382579
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Functional Chewing Gum in Reduction of Gingival Inflammation
- ClinicalTrials.gov ID
- NCT03237624
- Acronym / sponsor ID
- HP-00073354
- Conditions
- Gingivitis
- Keywords
- gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 2 Aug 2017 (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 aim of this prospective randomized 3-month double-blinded single center study is to determine whether a chewing gum device with food additive chitosan, will aid in reducing gingival inflammation by supplementing traditional tooth brushing and flossing measures. Patients with mild to moderate gingivitis will be identified and enrolled in this investigation. All enrolled subjects will receive baseline oral hygiene brushing instructions and a baseline clinical examination of the gingiva. The test group will utilize the test chewing gum three times a day for a minimum 20-30 minutes duration; the control group will receive a placebo gum and use it in a similar manner. We will examine whether daily use of a functional chewing gum enhances improvements to brushing and flossing.
Detailed description
Periodontal disease remains a prevalent and preventable disease in man. Plaque bacterial biofilm remains the primary etiologic agent of disease; colonization of non-shedding tooth surfaces greatly contributes to initiation and progression of gingivitis, for example. Although there are currently available chemotherapeutic agents to supplement daily oral hygiene measures, one continuous issue is patient compliance. Chewing gum represents a unique delivery device for not only drugs and other agents, but food additives that might aid in reducing bacteria plaque colonization on tooth surfaces. For example, chitosan and chitosan-related food additive preparations have been shown to have some antimicrobial-like properties, possibly in the disruption of bacterial colonization (not -cidal).
NOTE: ALL INGREDIENTS of the "test" chewing gum, and the placebo chewing gum, are generally regarded as safe ("GRAS" label by the Food and Drug Administration), as they are common food components. For example, chitosan is listed in the GRAS database (https://www.accessdata.fda.gov/scripts/fdcc/?set=SCOGS). See item GRN No. 397.
This study aims to determine whether adjunctive use of functional chewing gum will improve gingival inflammation status-retaining clinical gains initiated by professional tooth cleaning and at home brushing over a 12 week period in gingivitis patients.
Eligibility criteria and outcome measures are described in the next section.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional chewing gum | Experimental | Device: Functional Chitosan Chewing Gum, Behavioral: Oral hygiene measuresSubjects given as intervention functional chewing gum device to supplement oral hygiene practices. Functional gum contains chitosan which is a food additive or generally recognized as safe food product. Individuals will use this gum 20 to 30 minutes three times per day. Subjects will brush and floss normally twice a day. |
| Control chewing gum | Placebo comparator | Device: Control Chewing Gum, Behavioral: Oral hygiene measuresSubjects given control gum to supplement oral hygiene practices. Placebo gum does not contain any active ingredients. Individuals will use this gum 20 to 30 minutes three times per day. Subjects will brush and floss normally twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild-moderate gingivitis
- Minimum of 20 natural teeth
Key exclusion criteria (10 listed)
- Significant alveolar bone loss as evidenced by Bite-wings (>3.0 mm cementoenamel junction to bone)
- Requirement for antibiotic pre-medication prior to dental procedures
- Systemic antibiotic use in past 14 days to current.
- Use of oral contraceptives
- Use of anti-inflammatory (NSAIDs) or in past 14 days.
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 |
|---|---|---|
| Functional Chitosan Chewing GumChitosan and chitosan-related preparations have been shown to have some antimicrobial properties, possibly in the disruption of bacterial colonization. It is thought that as a component of a functional chewing gum this will supplement in the removal of daily build up of dental plaque on tooth surfaces. | Device | Functional chewing gum |
| Control Chewing GumControl chewing gum device does not have food additive chitosan in its composition. | Device | Control chewing gum |
| Oral hygiene measuresPatients will be given instructions on how to brush and floss routinely (twice per day) | Behavioural | Control chewing gum, Functional chewing gum |
Primary outcome
Gum inflammation change
Time frame: Change in color of gingiva from baseline to 12 weeks
Measure the color of gingiva - use Gingiva Index
1 secondary outcome
Plaque levels (on teeth) change
Time frame: Change in plaque level from baseline to 12 weeks
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 26 Nov 2024.
- Background: PubMed 23488873Kaur S, Dhillon GS. The versatile biopolymer chitosan: potential sources, evaluation of extraction methods and applications. Crit Rev Microbiol. 2014 May;40(2):155-75. doi: 10.3109/1040841X.2013.770385. Epub 2013 Mar 14.
- Background: PubMed 25855683Machul A, Mikolajczyk D, Regiel-Futyra A, Heczko PB, Strus M, Arruebo M, Stochel G, Kyziol A. Study on inhibitory activity of chitosan-based materials against biofilm producing Pseudomonas aeruginosa strains. J Biomater Appl. 2015 Sep;30(3):269-78. doi: 10.1177/0885328215578781. Epub 2015 Apr 8.
- Background: PubMed 20437720Li Y, Lee S, Hujoel P, Su M, Zhang W, Kim J, Zhang YP, DeVizio W. Prevalence and severity of gingivitis in American adults. Am J Dent. 2010 Feb;23(1):9-13.
- Background: PubMed 10382579Simons D, Beighton D, Kidd EA, Collier FI. The effect of xylitol and chlorhexidine acetate/xylitol chewing gums on plaque accumulation and gingival inflammation. J Clin Periodontol. 1999 Jun;26(6):388-91. doi: 10.1034/j.1600-051x.1999.260609.x.
- 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.
Harlan Shiau, DDS principal investigator
UMSOD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Chitosan Chewing Gum and Oral hygiene measures in people with Gingivitis, run by University of Maryland, Baltimore at 1 site in United States.
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 2 inclusion and 10 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Gum inflammation change (time frame: Change in color of gingiva from baseline to 12 weeks). 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 NCT03237624, 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 26 Nov 2024.