NCT01877421

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

February 25, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 13, 2017

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

May 14, 2013

Results QC Date

January 30, 2017

Last Update Submit

February 11, 2020

Conditions

PlaqueGingivitis

Keywords

Reducing plaqueReducing gingivitissafetyproof of conceptantiplaque chewing gum

Outcome Measures

Primary Outcomes (1)

  • 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)

    Up to 28 days

Secondary Outcomes (3)

  • Proof of Concept of KSL-W in Reducing Plaque in Phase 2a

    days 14, 28, 34

  • Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a

    days 14, 28, 34

  • Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a

    days 0, 14, 28, 34

Study Arms (10)

2 mg KSL-W (Phase 1, 1a)

EXPERIMENTAL

one 2 mg KSL-W tablet at day 0 at Phase 1

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.

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.

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.

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.

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.

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.

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.

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

Drug: 100 mg KSL-W

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

2 mg KSL-WDRUG
Also known as: Antiplaque Chewing Gum
2 mg KSL-W (Phase 1, 1a)
4 mg KSL-WDRUG
Also known as: Antiplaque Chewing Gum
4 mg KSL-W (Phase 1, 2a; Phase 2a, 1b)
6 mg KSL-WDRUG
Also known as: Antiplaque Chewing Gum
6 mg KSL-W (Phase 1, 3a; Phase 2a, 2b)
10 mg KSL-WDRUG
Also known as: Antiplaque Chewing Gum
10 mg KSL-W (Phase 1, 4a; Phase 2a, 3b)
20 mg KSL-WDRUG
Also known as: Antiplaque Chewing Gum
20 mg KSL-W (Phase 1, 5a; Phase 2a, 4b)
30 mg KSL-WDRUG
Also known as: Antiplaque Chewing Gum
30 mg KSL-W (Phase 1, 6a; Phase 2a, 5b)
50 mg KSL-WDRUG
Also known as: Antiplaque Chewing Gum
50 mg KSL-W (Phase 1, 7a; Phase 2a, 6b)
75 mg KSL-WDRUG
Also known as: Antiplaque Chewing Gum
75 mg KSL-W (Phase 1, 8a; Phase 2a, 7b)
100 mg KSL-WDRUG
Also known as: Antiplaque Chewing Gum
100 mg KSL-W (Phase 1, 9a)
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.

Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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
  • 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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Dentistry, Oral Health Research Institute

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 39466933DERIVED

MeSH Terms

Conditions

Plaque, AmyloidGingivitis

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Domenick T. Zero, DDS, MS
Organization
Oral Health Research Institute, Indiana University School of Dentistry
dzero@iu.edu
240-457-0668

Study Officials

  • Domenick T Zero, DDS, MS

    Oral Health Research Institute, Indiana University School of Dentistry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2013

First Posted

June 13, 2013

Study Start

February 25, 2014

Primary Completion

August 25, 2015

Study Completion

March 1, 2016

Last Updated

February 13, 2020

Results First Posted

September 13, 2017

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)