The Safety, efficacy and tolerability of an Antimicrobial Chewing Gum Formulation in Reducing Dental Plaque
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
27
Antimicrobial KSL-W Plaque reducing chewing gum
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.
Time frame: Baseline, and Day 4 Following Three-days of Chewing Gum Treatment
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
Time frame: 4 Days
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