Is an Antiplaque Chewing Gum (30 mg) Able to Reduce Dental Plaque in a Healthy Population?

NCT ID: NCT02864901

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2016-11-30

Brief Summary

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.

Conditions

Plaque Regrowth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

KSL-W 30 mg

3 times per day over 4 treatment days

Group Type: EXPERIMENTAL

KSL-W

Intervention Type: DRUG

Antimicrobial KSL-W Plaque reducing chewing gum

Chewing Gum Placebo

3 times per day over 4 treatment days

Group Type: PLACEBO_COMPARATOR

KSL-W

Intervention Type: DRUG

Antimicrobial KSL-W Plaque reducing chewing gum

Interventions

KSL-W

Antimicrobial KSL-W Plaque reducing chewing gum

Intervention Type: DRUG

Other Intervention Names

Antimicrobial decapeptide KSL-W

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffery L Milleman, DDS, MPA

Role: PRINCIPAL_INVESTIGATOR

Salus Research

References

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.

Reference Type: DERIVED

PMID: 32558314 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

S-16-10

Identifier Type: -

Identifier Source: org_study_id