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Four-day plaque regrowth evaluation of a peptide chewing gum in a double-blind randomized clinical trial.

ABSTRACT: OBJECTIVE:Antimicrobial peptide, KSL-W, formulated as an antiplaque chewing gum (APCG), was tested to evaluate the dental plaque inhibition activity and safety in an IRB approved and FDA regulated 4-day plaque regrowth clinical study. METHODS:This Phase 2 two-armed placebo-controlled, double blind, randomized (1:1), multiple dose, and single-center study was evaluated in a proof of concept for the APCG containing 30?mg antimicrobial peptide KSL-W. Twenty six generally healthy subjects were consented and randomized into the study. The subjects were administered a dose three times per day for four treatment days following a complete dental prophylaxis. Participants were prohibited from conducting oral hygiene care (teeth brushing, flossing, and/or mouth wash rinse) for the duration of the trial. Twelve to 16?hr prior to the baseline visit, the subjects were to abstain from oral hygiene care. The Quigley-Hein Turesky plaque index (QHT) score and the oral soft tissue clinical exams were obtained at both Day 0 and Day 4. RESULTS:All randomized study subjects that received either APCG or placebo gum completed the study with no significant adverse events recorded. The APCG significantly inhibited the regrowth of dental plaque over the course of 4?days. The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two-tailed P value of .0003. CONCLUSION:Considering the limited sample size, the proof of concept analysis in this Phase 2 study confirmed that APCG is effective against dental plaque formation and safe for human use. (ClinicalTrials.gov Study ID# NCT02864901).

SUBMITTER: Kirkwood B

PROVIDER: S-EPMC7301399 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Four-day plaque regrowth evaluation of a peptide chewing gum in a double-blind randomized clinical trial.

Kirkwood Brian B Miller Michael M Milleman Jeffery J Milleman Kimberly K Leung Kai K

Clinical and experimental dental research 20191214 3

<h4>Objective</h4>Antimicrobial peptide, KSL-W, formulated as an antiplaque chewing gum (APCG), was tested to evaluate the dental plaque inhibition activity and safety in an IRB approved and FDA regulated 4-day plaque regrowth clinical study.<h4>Methods</h4>This Phase 2 two-armed placebo-controlled, double blind, randomized (1:1), multiple dose, and single-center study was evaluated in a proof of concept for the APCG containing 30 mg antimicrobial peptide KSL-W. Twenty six generally healthy subj ...[more]

PMID: 32558314

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Project description:Background: The oral cavity harbors a complex microbial ecosystem, intimately related to oral health and disease. The use of polyol-sweetened gum is believed to benefit oral health through stimulation of salivary flow and impacting oral pathogenic bacteria. Maltitol is often used as sweetener in food products. This study aimed to establish the in vivo effects of frequent consumption of maltitol-sweetened chewing gum on the dental plaque microbiota in healthy volunteers and to establish the cellular and molecular effects by in vitro cultivation and transcriptional analysis. Results: An intervention study was performed in 153 volunteers, randomly assigned to three groups (www.trialregister.nl; NTR4165). One group was requested to use maltitol gum five times daily, one group used gum-base, and the third group did not use chewing gum. At day 0 and day 28, 24 h-accumulated supragingival plaque was collected at the lingual sites of the lower jaw and the buccal sites of the upper jaw and analyzed by 16S ribosomal rRNA gene sequencing. At day 42, 2 weeks after completion of the study, lower-jaw samples were collected and analyzed. The upper buccal plaque microbiota composition had lower bacterial levels and higher relative abundances of (facultative) aerobic species compared to the lower lingual sites. There was no difference in bacterial community structure between any of the three study groups (PERMANOVA). Significant lower abundance of several bacterial phylotypes was found in maltitol gum group compared to the gum-base group, including Actinomyces massiliensis HOT 852 and Lautropia mirabilis HOT 022. Cultivation studies confirmed growth inhibition of A. massiliensis and A. johnsonii by maltitol at levels of 1% and higher. Transcriptome analysis of A. massiliensis revealed that exposure to maltitol resulted in changes in the expression of genes linked to osmoregulation, biofilm formation, and central carbon metabolism. Conclusion: The results showed that chewing itself only marginally impacted the plaque microbiota composition. Use of maltitol-sweetened gum lowered abundance of several bacterial species. Importantly, the species impacted play a key role in the early formation of dental biofilms. Further studies are required to establish if frequent use of maltitol gum impacts early dental-plaque biofilm development.

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Four-day plaque regrowth evaluation of a peptide chewing gum in a double-blind randomized clinical trial.

Publications

Four-day plaque regrowth evaluation of a peptide chewing gum in a double-blind randomized clinical trial.

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