Plaque RegrowthPhase 2APCGNCT02864901
Is an Antiplaque Chewing Gum (30 mg) Able to Reduce Dental Plaque in a Healthy Population?
A Phase 2 study testing KSL-W in people with Plaque Regrowth, run by U.S. Army Medical Research and Development Command.
Trial summary
The Safety, efficacy and tolerability of an Antimicrobial Chewing Gum Formulation in Reducing Dental Plaque Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Regrowth
- What is being tested?
- KSL-W
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A negative urine pregnancy test (females of childbearing potential only)
- A negative urine drug test
- On a reliable form of birth control for at least 30 days prior to the start of the study and willing to use a reliable form of contraception for the duration of the study (Females of childbearing potential only), with reliable contraception defined as:
- Abstinence which has been the customary lifestyle of choice
- Oral contraceptive, either estrogen progesterone combined, or progesterone alone
- Injectable progesterone
Show all 23Show fewer
- Implants of levonorgestrel
- Estrogenic vaginal ring
- Percutaneous contraceptive patches
- Intrauterine device or intrauterine system
- Double barrier method [condom or occlusive cap (diaphragm or cervical vault caps) plus spermicidal agent (foam, gel, film, cream, suppository)]
- Male partner sterilization at least 6 months prior to the female subject's entry into the study, and this male is the sole partner for that subject
- Post-menopausal for at least two years
- Good health, as determined by pertinent medical history, physical examination, and vital signs
- A minimum of 20 natural teeth with 6 scorable surfaces per tooth
- Sufficient number of opposing posterior teeth to chew on both sides of the mouth as determined by the examining dentist
- Teeth that have gross caries, full crowns or extensive restorations on facial and/or lingual surfaces, orthodontic bands, and third molars are not included in the tooth count
- Subject must have refrained from all oral hygiene procedures 12 to 16 hours prior to screening visit
- Plaque Index of 1.95 or greater (Turesky et al-1970)
- Willing to forgo any optional dental procedures during the study period, such as dental prophylaxis or teeth whitening
- Ability to comprehend and a willingness to sign an informed consent, which includes the Authorization for the Release of Health Information document
- Ability to access the internet to complete the drug compliance information
- Willingness to comply with all study procedures
Who cannot join
- E01 Phenylketonuria E02 Acute or chronic medical conditions, organ system disease, or medications that, in the principal investigator's opinion, would impair the subject's ability to participate E03 TMD E04 Self-reported allergy to sucralose or mint flavors E05 Self-reported use of tobacco products including e-cigarettes E06 Use of any type of anticoagulant medications (eg clopidogrel) E07 Routine use of proton pump inhibitors E08 Allergic to any component of the study drug E09 Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or calculus, or soft or hard tissue tumor of the oral cavity E010Orthodontic appliances or removable partial dentures that will compromise the ability of the potential subject to participate in the study E011Periodontitis as indicated by periodontal pockets greater than 4 millimeters on more than one site E012 Receipt of any investigational drug/test product within 30 days prior to study entry with study entry defined as Day 0, or currently participating in either the active or follow-up phase of any other investigational study or planning to participate in any other investigational study during participation in this trial E013 Participation in the Phase 1/2a antiplaque study E014 Receipt of antibiotics within 30 days prior to study entry E015 Need for antibiotic prophylaxis prior to invasive dental procedures E016 Receipt of prescription antibacterial oral products (eg products containing chlorhexidine) within 30 days prior to study entry E017 Pregnant or breast-feeding female E018 An employee of the study site directly involved with the study E019 Inability to comply with assigned treatment regimen
About this study
Official title: A Double-Blind, Randomized, Placebo Controlled, Clinical Trial of an Antiplaque Chewing Gum (30 mg) - Phase 2 Proof of Concept in a Generally Healthy Patient Population
The Safety, efficacy and tolerability of an Antimicrobial Chewing Gum Formulation in Reducing Dental Plaque
Read the detailed description
A Phase 2 two-armed placebo-controlled, double-blind, randomized (1:1), multiple dose, single center interventional study to evaluate the safety and proof of concept for an antimicrobial decapeptide KSL-W chewing gum formulation 3 times per day over 4 treatment days measuring dental plaque regrowth from specific regions of the upper jaw, lower jaw, buccal and lingual surfaces.
- Conditions
- Plaque Regrowth
- Being tested
- KSL-W
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSL-WDrug
Also called Antimicrobial decapeptide KSL-W
Antimicrobial KSL-W Plaque reducing chewing gum
| Study group | Role | What they receive |
|---|---|---|
| KSL-W 30 mg | Experimental | 3 times per day over 4 treatment days Receives: Drug: KSL-W |
| Chewing Gum Placebo | Placebo comparator | 3 times per day over 4 treatment days Receives: Drug: KSL-W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, Tolerability and Effectiveness in Reducing Dental Plaque of KLS-W Delivered in a Chewing Gum Formulation
Day 4 Exam Following 72-hours of Chewing Gum Treatment. Exam Included Vital Signs and Whole Mouth Dental Examination (Maxillary Buccal, Maxillary Lingual, Mandibular Buccal and Mandibular Surfaces) Assessing for Local Oral Mucosal Reactions, Systemic Reactions and Serious Total Body Reactions.
Measured: Baseline, and Day 4 Following Three-days of Chewing Gum Treatment
Secondary outcomes (1)
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures
The Amount of Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Based on the Quigley-Hein Turskey Plaque Index (QHT) a measure that evaluates plaque on teeth surfaces on a scale of 0 to 5 defined by Quigley \&Hein in 1962 and modified by Turskey et al in 1970. All teeth except the third molars are assessed. An index for the entire mouth is determined by dividing the total score by the number of surfaces examined. Quigley-Hein-Turskey Plaque Index Scale Minimum score 0=no plaque, 1-Isolated flecks of plaque at the gingival margin, 2=A continuous band of plaque up to 1mm at the gingival margin, 3=Plaque greater than 1mm in width and covering up to one third of the tooth surface, 4=Plaque covering from one thirds to two thirds of the tooth surface, Maximum score of 5=Plaque covering more than two thirds of the tooth surface
Measured: 4 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque RegrowthStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeffery L Milleman, DDS, MPA, Principal investigator, Salus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864901
- Sponsor's protocol ID
- S-16-10
- Acronym
- APCG
- Status last verified
- Jul 2025
- First submitted
- 9 Aug 2016
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kirkwood B, Miller M, Milleman J, Milleman K, Leung K. Four-day plaque regrowth evaluation of a peptide chewing gum in a double-blind randomized clinical trial. Clin Exp Dent Res. 2020 Jun;6(3):318-327. doi: 10.1002/cre2.275. Epub 2019 Dec 14.
PubMed 32558314
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo Controlled, Clinical Trial of an Antiplaque Chewing Gum (30 mg) - Phase 2 Proof of Concept in a Generally Healthy Patient Population
- ClinicalTrials.gov ID
- NCT02864901
- Acronym / sponsor ID
- APCG / S-16-10
- Conditions
- Plaque Regrowth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Safety, efficacy and tolerability of an Antimicrobial Chewing Gum Formulation in Reducing Dental Plaque
Detailed description
A Phase 2 two-armed placebo-controlled, double-blind, randomized (1:1), multiple dose, single center interventional study to evaluate the safety and proof of concept for an antimicrobial decapeptide KSL-W chewing gum formulation 3 times per day over 4 treatment days measuring dental plaque regrowth from specific regions of the upper jaw, lower jaw, buccal and lingual surfaces.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KSL-W 30 mg | Experimental | Drug: KSL-W3 times per day over 4 treatment days |
| Chewing Gum Placebo | Placebo comparator | Drug: KSL-W3 times per day over 4 treatment days |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- A negative urine pregnancy test (females of childbearing potential only)
- A negative urine drug test
- On a reliable form of birth control for at least 30 days prior to the start of the study and willing to use a reliable form of contraception for the duration of the study (Females of childbearing potential only), with reliable contraception defined as:
- Abstinence which has been the customary lifestyle of choice
- Oral contraceptive, either estrogen progesterone combined, or progesterone alone
Key exclusion criteria (1 listed)
- E01 Phenylketonuria E02 Acute or chronic medical conditions, organ system disease, or medications that, in the principal investigator's opinion, would impair the subject's ability to participate E03 TMD E04 Self-reported allergy to sucralose or mint flavors E05 Self-reported use of tobacco products including e-cigarettes E06 Use of any type of anticoagulant medications (eg clopidogrel) E07 Routine use of proton pump inhibitors E08 Allergic to any component of the study drug E09 Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or calculus, or soft or hard tissue tumor of the oral cavity E010Orthodontic appliances or removable partial dentures that will compromise the ability of the potential subject to participate in the study E011Periodontitis as indicated by periodontal pockets greater than 4 millimeters on more than one site E012 Receipt of any investigational drug/test product within 30 days prior to study entry with study entry defined as Day 0, or currently participating in either the active or follow-up phase of any other investigational study or planning to participate in any other investigational study during participation in this trial E013 Participation in the Phase 1/2a antiplaque study E014 Receipt of antibiotics within 30 days prior to study entry E015 Need for antibiotic prophylaxis prior to invasive dental procedures E016 Receipt of prescription antibacterial oral products (eg products containing chlorhexidine) within 30 days prior to study entry E017 Pregnant or breast-feeding female E018 An employee of the study site directly involved with the study E019 Inability to comply with assigned treatment regimen
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 |
|---|---|---|
| KSL-WAlso: Antimicrobial decapeptide KSL-WAntimicrobial KSL-W Plaque reducing chewing gum | Drug | Chewing Gum Placebo, KSL-W 30 mg |
Primary outcome
Safety, Tolerability and Effectiveness in Reducing Dental Plaque of KLS-W Delivered in a Chewing Gum Formulation
Time frame: Baseline, and Day 4 Following Three-days of Chewing Gum Treatment
Day 4 Exam Following 72-hours of Chewing Gum Treatment. Exam Included Vital Signs and Whole Mouth Dental Examination (Maxillary Buccal, Maxillary Lingual, Mandibular Buccal and Mandibular Surfaces) Assessing for Local Oral Mucosal Reactions, Systemic Reactions and Serious Total Body Reactions.
1 secondary outcome
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures
Time frame: 4 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32558314Kirkwood B, Miller M, Milleman J, Milleman K, Leung K. Four-day plaque regrowth evaluation of a peptide chewing gum in a double-blind randomized clinical trial. Clin Exp Dent Res. 2020 Jun;6(3):318-327. doi: 10.1002/cre2.275. Epub 2019 Dec 14.
Related trials for Plaque Regrowth
RecruitingObservational study
UV-Trichoscopic Red Fluorescence in Alopecia Areata
Alopecia Areata
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.
Jeffery L Milleman, DDS, MPA principal investigator
Salus Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KSL-W in people with Plaque Regrowth, run by U.S. Army Medical Research and Development Command.
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 23 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 15 Jul 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety, Tolerability and Effectiveness in Reducing Dental Plaque of KLS-W Delivered in a Chewing Gum Formulation (time frame: Baseline, and Day 4 Following Three-days of Chewing Gum Treatment). 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 NCT02864901, which also lists 1 linked publication.
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 15 Jul 2025.