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

Phase 2

Completed

Conditions: Plaque Regrowth

Interventions: Drug: KSL-W

Registration Number: NCT02864901

Lead Sponsor: U.S. Army Medical Research and Development Command

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KSL-W 30 mg	KSL-W	3 times per day over 4 treatment days
Chewing Gum Placebo	KSL-W	3 times per day over 4 treatment days

Primary Outcome Measures

Name	Time	Method
Safety, Tolerability and Effectiveness in Reducing Dental Plaque of KLS-W Delivered in a Chewing Gum Formulation	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.

Secondary Outcome Measures

Name	Time	Method
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	4 Days	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