PlaquePhase 1/2APCGNCT01877421

Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population

A Phase 1/2 study testing 2 mg KSL-W, 4 mg KSL-W and 6 mg KSL-W in people with Plaque and Gingivitis, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Plaque, Gingivitis
What is being tested?: 2 mg KSL-W, 4 mg KSL-W and 6 mg KSL-W
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 135 participants
Where: 1 siteUnited States
Study dates: 25 Feb 2014to Mar 2016
Phase: Phase 1/2
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

Subjects must meet all of the following criteria to be included in the Phase 1 portion of the study:
Males and females between 18 and 64 years of age
A negative urine pregnancy test and willingness to use a reliable form of contraception for the duration of the study (females of childbearing potential only), with reliable contraception defined as:
Abstinence Oral contraceptive, either estrogen progesterone combined, or progesterone alone Injectable progesterone 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 prior to the female subject's entry into the study, and this male is the sole partner for that subject
Good health, as determined by pertinent medical history, physical examination, vital signs, and clinical safety laboratory evaluations
A minimum of 16 natural teeth with 2 scorable surfaces (facial and lingual) 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

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Ability to comprehend and a willingness to sign an informed consent, which includes the Authorization for the Release of Health Information document
Willingness to comply with all study procedures
Phase 2a Inclusion Criteria
Subjects must meet all the criteria for the phase 1 portion of the study, and in addition must:
Have mild to moderate gingivitis and plaque MGI of 1.8 or greater (Ainamo and Bay-1975) PI 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

Who cannot join

Subjects meeting any of the following criteria will be excluded from the study:
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
TMD
Self-reported use of tobacco products
Use of anticoagulant medications (eg clopidogrel)
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

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Orthodontic appliances or removable partial dentures that will compromise the ability of the potential subject to participate in the study
Periodontitis as indicated periodontal pockets greater than 4 millimeters on more than one site
Receipt of any investigational drug/test product within 30 days prior to study entry
Receipt of antibiotics within 30 days prior to study entry
Need for antibiotic prophylaxis prior to invasive dental procedures
Receipt of daily anti-inflammatory therapy [eg nonsteroidal anti-inflammatory drugs (NSAID), tumor necrosis factor (TNF) alpha blockers] within 30 days prior to study entry
Receipt of prescription antibacterial oral products (eg products containing chlorhexidine) within 30 days prior to study entry
Pregnant or breast-feeding female
Clinically significant abnormal laboratory tests as determined by the principal investigator
An employee of the study site directly involved with the study
Inability to comply with assigned treatment regimen

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University School of Dentistry, Oral Health Research Institute
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Controlled, Dose Escalation Clinical Trial of an Antiplaque Chewing Gum - Phase 1 Safety and Tolerability and Phase 2a Safety, Tolerability, and Proof of Concept in a Gingivitis Population

This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation.

Read the detailed description

This study is a Phase 1/2a placebo-controlled, double-blind, randomized, dose-escalation study to evaluate the safety and proof of concept of Antiplaque Chewing Gum. This is a 2-part trial with 9 dosing cohorts in Phase 1 and 7 dosing cohorts in Phase 2a. For both phases, the oral soft (OST) and oral hard tissues (OHT) will be examined. Changes from baseline, such as soft tissue erythema, ulceration and sloughing, will be noted and assessments will be made by the principal investigator as to whether they might be attributable to the antiplaque chewing gum.

In the Phase 2a portion of the study, the efficacy of the antiplaque chewing gum in reducing existing supragingival plaque and gingivitis will also be assessed. Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index (PI, Turesky et al-1970) and gingivitis will be assessed using both the Modified Gingival Index (MGI, Lobene et al-1986) and the percent of bleeding sites on gentle probing (BOP) using the methods described in Ainamo and Bay-1975.

Conditions: Plaque, Gingivitis
Being tested: 2 mg KSL-W, 4 mg KSL-W, 6 mg KSL-W, 10 mg KSL-W, 20 mg KSL-W
Keywords: Reducing plaque, Reducing gingivitis, safety, proof of concept, antiplaque chewing gum
Medical subject headings: Plaque, Amyloid, Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

2 mg KSL-WDrug
Also called Antiplaque Chewing Gum
4 mg KSL-WDrug
Also called Antiplaque Chewing Gum
6 mg KSL-WDrug
Also called Antiplaque Chewing Gum
10 mg KSL-WDrug
Also called Antiplaque Chewing Gum
20 mg KSL-WDrug
Also called Antiplaque Chewing Gum
30 mg KSL-WDrug
Also called Antiplaque Chewing Gum
50 mg KSL-WDrug
Also called Antiplaque Chewing Gum
75 mg KSL-WDrug
Also called Antiplaque Chewing Gum
100 mg KSL-WDrug
Also called Antiplaque Chewing Gum
PlaceboOther
Cetylpyridinium chloride (CPC) as an additive, isomalt as a bulk sweetener, peppermint powder for flavoring, sucralose as an intense sweetener, colloidal silicon dioxide is a flow enhancer, magnesium stearate as a process aid, and the proprietary gum base formulation.

Study groups in NCT01877421
Study group	Role	What they receive
2 mg KSL-W (Phase 1, 1a)	Experimental	one 2 mg KSL-W tablet at day 0 at Phase 1 Receives: Drug: 2 mg KSL-W
4 mg KSL-W (Phase 1, 2a; Phase 2a, 1b)	Experimental	one 4 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. one 4 mg KSL-W tablet on days 1-6; two 4 mg KSL-W tablets on days 7-13 and days 14-20; and three 4 mg tablets at days 21-27 at Phase 2a. Receives: Drug: 4 mg KSL-W
6 mg KSL-W (Phase 1, 3a; Phase 2a, 2b)	Experimental	One 6 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 6 mg KSL-W tablet on days 1-6; two 6 mg KSL-W tablets on days 7-13 and days 14-20; and three 6 mg tablets at days 21-27 at Phase 2a. Receives: Drug: 6 mg KSL-W
10 mg KSL-W (Phase 1, 4a; Phase 2a, 3b)	Experimental	One 10 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 10 mg KSL-W tablet on days 1-6; two 10 mg KSL-W tablets on days 7-13 and days 14-20; and three 10 mg tablets at days 21-27 at Phase 2a. Receives: Drug: 10 mg KSL-W
20 mg KSL-W (Phase 1, 5a; Phase 2a, 4b)	Experimental	One 20 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 20 mg KSL-W tablet on days 1-6; two 20 mg KSL-W tablets on days 7-13 and days 14-20; and three 20 mg tablets at days 21-27 at Phase 2a. Receives: Drug: 20 mg KSL-W
30 mg KSL-W (Phase 1, 6a; Phase 2a, 5b)	Experimental	One 30 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 30 mg KSL-W tablet on days 1-6; two 30 mg KSL-W tablets on days 7-13 and days 14-20; and three 30 mg tablets at days 21-27 at Phase 2a. Receives: Drug: 30 mg KSL-W
50 mg KSL-W (Phase 1, 7a; Phase 2a, 6b)	Experimental	One 50 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 50 mg KSL-W tablet on days 1-6; two 50 mg KSL-W tablets on days 7-13 and days 14-20; and three 50 mg tablets at days 21-27 at Phase 2a. Receives: Drug: 50 mg KSL-W
75 mg KSL-W (Phase 1, 8a; Phase 2a, 7b)	Experimental	One 75 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 75 mg KSL-W tablet on days 1-6; two 75 mg KSL-W tablets on days 7-13 and days 14-20; and three 75 mg tablets at days 21-27 at Phase 2a. Receives: Drug: 75 mg KSL-W
100 mg KSL-W (Phase 1, 9a)	Experimental	one 100 mg KSL-W tablet at day 0 at Phase 1 Receives: Drug: 100 mg KSL-W
Placebo	Placebo comparator	Placebo Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs)
Occurrence of local oral mucosal reactions, systemic reactions such as fever, nausea, headache, and changes in blood pressure, clinical laboratory measures of safety, and serious total body reactions will be assessed (AEs and SAEs)
Measured: Up to 28 days

Secondary outcomes (3)

Proof of Concept of KSL-W in Reducing Plaque in Phase 2a
Data summarizes plaque index scores changes from baseline. Supragingival plaque will be assessed after the MGI and BOP assessments and following use of a disclosing solution on the facial (buccal) and lingual surfaces of a minimum of 16 scorable teeth according to the criteria of the Turesky modification of the Quigley-Hein Plaque Index.
Quigley-Hein Plaque Index Scores with Turesky Modifications:
0 No plaque
1. Separate flecks of plaque at the cervical margin of the tooth
2. A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
3. A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
4. Plaque covering at least one-third but less than two thirds of the crown of the tooth
5. Plaque covering two-thirds or more of the crown of the tooth
Measured: days 14, 28, 34
Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a
Data summarizes gingival index scores changes from baseline in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP) The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae.
Modified Gingival Index Scores:
0 Absence of inflammation
1. Mild inflammation; slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit
2. Mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit
3. Moderate inflammation; glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit
4. Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.
Measured: days 14, 28, 34
Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a
Proof of concept of KSL-W in reducing plaque as measured by percent of bleeding sites upon probing (BOP) in phase 2a.
Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP). The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae. The Gingival Bleeding Index assesses the percentage of sites that bleed on gentle probing. A periodontal probe (HU-Friedy UNC 15) will be gently inserted into the gingival sulcus until resistance is felt at mid-facial (buccal), mid-lingual, mesial, and distal interproximal sites of all scorable teeth, with the exception of the most posterior distal sites. Presence or absence of bleeding will be recorded for each site and the percentage of bleeding sites per subject will serve as the unit of analysis.
Measured: days 0, 14, 28, 34

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 2014Mar 2016

First posted13 Jun 2013 (estimated)
Study start25 Feb 2014
Primary completion25 Aug 2015
Study completionMar 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 PlaqueStudies 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01877421
Sponsor's protocol ID: S-11-14
Acronym: APCG
Status last verified: Feb 2020
First submitted: 14 May 2013
Last updated: 13 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ryan JB, Kirkwood BJ, Leung KP. Combined Phase 1/2a Initial Clinical Safety Trials and Proof-of-Concept Assessment of a Novel Antimicrobial Peptide KSL-W Anti-Plaque Chewing Gum. Clin Exp Dent Res. 2024 Dec;10(6):e943. doi: 10.1002/cre2.943.
PubMed 39466933

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Controlled, Dose Escalation Clinical Trial of an Antiplaque Chewing Gum - Phase 1 Safety and Tolerability and Phase 2a Safety, Tolerability, and Proof of Concept in a Gingivitis Population
ClinicalTrials.gov ID: NCT01877421
Acronym / sponsor ID: APCG / S-11-14
Conditions: Plaque, Gingivitis
Keywords: Reducing plaque, Reducing gingivitis, safety, proof of concept, antiplaque chewing gum
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Study start: 25 Feb 2014 (actual)
Primary completion: 25 Aug 2015 (actual)
Study completion: Mar 2016 (actual)
First posted: 13 Jun 2013 (estimated)
Results: Posted 13 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
2 mg KSL-W (Phase 1, 1a)	Experimental	Drug: 2 mg KSL-Wone 2 mg KSL-W tablet at day 0 at Phase 1
4 mg KSL-W (Phase 1, 2a; Phase 2a, 1b)	Experimental	Drug: 4 mg KSL-Wone 4 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. one 4 mg KSL-W tablet on days 1-6; two 4 mg KSL-W tablets on days 7-13 and days 14-20; and three 4 mg tablets at days 21-27 at Phase 2a.
6 mg KSL-W (Phase 1, 3a; Phase 2a, 2b)	Experimental	Drug: 6 mg KSL-WOne 6 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 6 mg KSL-W tablet on days 1-6; two 6 mg KSL-W tablets on days 7-13 and days 14-20; and three 6 mg tablets at days 21-27 at Phase 2a.
10 mg KSL-W (Phase 1, 4a; Phase 2a, 3b)	Experimental	Drug: 10 mg KSL-WOne 10 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 10 mg KSL-W tablet on days 1-6; two 10 mg KSL-W tablets on days 7-13 and days 14-20; and three 10 mg tablets at days 21-27 at Phase 2a.
20 mg KSL-W (Phase 1, 5a; Phase 2a, 4b)	Experimental	Drug: 20 mg KSL-WOne 20 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 20 mg KSL-W tablet on days 1-6; two 20 mg KSL-W tablets on days 7-13 and days 14-20; and three 20 mg tablets at days 21-27 at Phase 2a.
30 mg KSL-W (Phase 1, 6a; Phase 2a, 5b)	Experimental	Drug: 30 mg KSL-WOne 30 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 30 mg KSL-W tablet on days 1-6; two 30 mg KSL-W tablets on days 7-13 and days 14-20; and three 30 mg tablets at days 21-27 at Phase 2a.
50 mg KSL-W (Phase 1, 7a; Phase 2a, 6b)	Experimental	Drug: 50 mg KSL-WOne 50 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 50 mg KSL-W tablet on days 1-6; two 50 mg KSL-W tablets on days 7-13 and days 14-20; and three 50 mg tablets at days 21-27 at Phase 2a.
75 mg KSL-W (Phase 1, 8a; Phase 2a, 7b)	Experimental	Drug: 75 mg KSL-WOne 75 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 75 mg KSL-W tablet on days 1-6; two 75 mg KSL-W tablets on days 7-13 and days 14-20; and three 75 mg tablets at days 21-27 at Phase 2a.
100 mg KSL-W (Phase 1, 9a)	Experimental	Drug: 100 mg KSL-Wone 100 mg KSL-W tablet at day 0 at Phase 1
Placebo	Placebo comparator	Other: PlaceboPlacebo

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Subjects must meet all of the following criteria to be included in the Phase 1 portion of the study:
Males and females between 18 and 64 years of age
A negative urine pregnancy test and willingness to use a reliable form of contraception for the duration of the study (females of childbearing potential only), with reliable contraception defined as:
Abstinence Oral contraceptive, either estrogen progesterone combined, or progesterone alone Injectable progesterone 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 prior to the female subject's entry into the study, and this male is the sole partner for that subject
Good health, as determined by pertinent medical history, physical examination, vital signs, and clinical safety laboratory evaluations

Key exclusion criteria (17 listed)

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
TMD
Self-reported use of tobacco products
Use of anticoagulant medications (eg clopidogrel)
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

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
2 mg KSL-WAlso: Antiplaque Chewing Gum	Drug	2 mg KSL-W (Phase 1, 1a)
4 mg KSL-WAlso: Antiplaque Chewing Gum	Drug	4 mg KSL-W (Phase 1, 2a; Phase 2a, 1b)
6 mg KSL-WAlso: Antiplaque Chewing Gum	Drug	6 mg KSL-W (Phase 1, 3a; Phase 2a, 2b)
10 mg KSL-WAlso: Antiplaque Chewing Gum	Drug	10 mg KSL-W (Phase 1, 4a; Phase 2a, 3b)
20 mg KSL-WAlso: Antiplaque Chewing Gum	Drug	20 mg KSL-W (Phase 1, 5a; Phase 2a, 4b)
30 mg KSL-WAlso: Antiplaque Chewing Gum	Drug	30 mg KSL-W (Phase 1, 6a; Phase 2a, 5b)
50 mg KSL-WAlso: Antiplaque Chewing Gum	Drug	50 mg KSL-W (Phase 1, 7a; Phase 2a, 6b)
75 mg KSL-WAlso: Antiplaque Chewing Gum	Drug	75 mg KSL-W (Phase 1, 8a; Phase 2a, 7b)
100 mg KSL-WAlso: Antiplaque Chewing Gum	Drug	100 mg KSL-W (Phase 1, 9a)
PlaceboCetylpyridinium chloride (CPC) as an additive, isomalt as a bulk sweetener, peppermint powder for flavoring, sucralose as an intense sweetener, colloidal silicon dioxide is a flow enhancer, magnesium stearate as a process aid, and the proprietary gum base formulation.	Other	Placebo

Primary outcome

Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs)
Time frame: Up to 28 days
Occurrence of local oral mucosal reactions, systemic reactions such as fever, nausea, headache, and changes in blood pressure, clinical laboratory measures of safety, and serious total body reactions will be assessed (AEs and SAEs)

3 secondary outcomes

Proof of Concept of KSL-W in Reducing Plaque in Phase 2a
Time frame: days 14, 28, 34
Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a
Time frame: days 14, 28, 34
Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a
Time frame: days 0, 14, 28, 34

Results and safety

Results posted to the registry on 13 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2mg KSL-W	2	2
2mg Placebo	1	1
4mg KSL-W	4	4
4mg Placebo	2	2
6mg KSL-W	4	4
6mg Placebo	2	2
10mg KSL-W	4	4
10mg Placebo	2	2
20mg KSL-W	7	7
20mg Placebo	3	3
30mg KSL-W	7	7
30mg Placebo	3	3
50mg KSL-W	7	7
50mg Placebo	3	3
75mg KSL-W	7	7
75mg Placebo	3	3
100mg KSL-W	7	7
100mg Placebo	3	3

Primary outcome: Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs)

Time frame: Up to 28 days. Count of participants. Unit: Participants

Measure	Phase 1, 1a (2mg) n = 2	Phase 1, 1a Placebo n = 1	Phase 1, 2a (4mg) n = 4	Phase 1, 2a Placebo n = 2	Phase 1, 3a (6mg) n = 4	Phase 1, 3a Placebo n = 2	Phase 1, 4a (10mg) n = 4	Phase 1, 4a Placebo n = 2	Phase 1, 5a (20mg) n = 7	Phase 1, 5a Placebo n = 3	Phase 1, 6a (30mg) n = 7	Phase 1, 6a Placebo n = 3	Phase 1, 7a (50mg) n = 7	Phase 1, 7a Placebo n = 3	Phase 1, 8a (75mg) n = 7	Phase 1, 8a Placebo n = 3	Phase 1, 9a (100mg) n = 7	Phase 1, 9a Placebo n = 3	Phase 2, 1b (4mg) n = 4	Phase 2, 1b Placebo n = 2	Phase 2, 2b (6mg) n = 7	Phase 2, 2b Placebo n = 3	Phase 2, 3b (10mg) n = 7	Phase 2, 3b Placebo n = 2	Phase 2, 4b (20mg) n = 6	Phase 2, 4b Placebo n = 3	Phase 2, 5b (30mg) n = 7	Phase 2, 5b Placebo n = 3	Phase 2, 6b (50mg) n = 7	Phase 2, 6b Placebo n = 3	Phase 2, 7b (75mg) n = 7	Phase 2, 7b Placebo n = 3
Subject Experiencing AEs = NO	2	1	4	2	4	1	4	1	6	1	7	3	7	3	5	3	5	3	2	1	4	2	4	2	5	1	2	1	2	2	2	3
Subjects Experiencing AEs = YES	0	0	0	0	0	1	0	1	1	2	0	0	0	0	2	0	2	0	2	1	3	1	3	0	1	2	5	2	5	1	5	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1, 1a (2mg)	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Phase 1, 1a Placebo	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Phase 1, 2a (4mg)	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Phase 1, 2a Placebo	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Phase 1, 3a (6mg)	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Phase 1, 3a Placebo	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Phase 1, 4a (10mg)	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Phase 1, 4a Placebo	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Phase 1, 5a (20mg)	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
Phase 1, 5a Placebo	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Phase 1, 6a (30mg)	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Phase 1, 6a Placebo	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Phase 1, 7a (50mg)	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Phase 1, 7a Placebo	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Phase 1, 8a (75mg)	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7
Phase 1, 8a Placebo	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Phase 1, 9a (100mg)	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7
Phase 1, 9a Placebo	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Phase 2, 1b (4mg)	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Phase 2, 1b Placebo	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Phase 2, 2b (6mg)	0 of 7 (0%)	3 of 7 (42.9%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39466933Ryan JB, Kirkwood BJ, Leung KP. Combined Phase 1/2a Initial Clinical Safety Trials and Proof-of-Concept Assessment of a Novel Antimicrobial Peptide KSL-W Anti-Plaque Chewing Gum. Clin Exp Dent Res. 2024 Dec;10(6):e943. doi: 10.1002/cre2.943.
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.

Domenick T Zero, DDS, MS principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 2 mg KSL-W, 4 mg KSL-W and 6 mg KSL-W in people with Plaque and Gingivitis, run by U.S. Army Medical Research and Development Command 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 12 inclusion and 17 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 13 Feb 2020. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 13 Sep 2017). 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 and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) (time frame: Up to 28 days). 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 NCT01877421, 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 13 Feb 2020.