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Efficacy of a novel post-foaming dental gel on gingival inflammation: A randomized controlled clinical trial
Jonathan B Levine1, Jordan Goncalves1, Daniel Nguyen2
1GLO Science, Inc., New York, New York, USA.
Background:
A pilot randomized controlled clinical trial was performed to evaluate the efficacy of a post-foaming dental gel containing cetylpridinium chloride (CPC), hydrogen peroxide (H2 O2 ), sodium bicarbonate, and antioxidants on periodontal/oral health.
Methods:
Individuals with gingivitis or mild-moderate periodontitis (n=36) were included and randomly assigned to Group 1 and 2 with foaming gel loaded on a mouthpiece with a light source and controlled warming heat built-in unit or on a toothbrush, respectively, in addition to regular twice-daily brushing. Group 3 served as control with twice daily brushing and further assigned split-mouth to Group 3a-un-flossed and Group 3b-flossed. Gingival index (GI) and bleeding on probing (BOP) were evaluated in addition to plaque index (PI), pocket depth, and clinical attachment level at days 14, 28, 42 (treatment), and 60 (maintenance). Subgingival plaque microbial profiles and gingival crevicular fluid (GCF) cytokine levels were determined by DNA-DNA hybridization and multiplexing assays, respectively. Exploratory analyses included esthetic outcomes: changes in tooth color and levels of volatile sulfur compounds in breath. Statistical analyses were conducted using ANOVA with a post hoc analysis of Fisher's LSD.
Results:
Use of post-foaming gel in both test groups resulted in significant changes in GI and BOP at Day 42 compared to control and un-flossed control (P<0.05). Device-enhanced foaming gel significantly reduced the PI in Group 1 at Day 42 compared to control and un-flossed control (P=0.02; P=0.007, respectively). GCF IL-6 and TNF-α levels were significantly reduced in Group 2 compared to control (PIL-6 =0.01, PTNF-α =0.02). Post-foaming gel resulted in greater reductions in periodontopathogens, whereas health-associated species remained stable. Despite cessation of adjunct treatments, Group 1 and 2 continued having reduced levels of GI, BOP, and PI at Day 60 (P<0.05).
Conclusions:
The novel post-foaming dental gel improves oral health by reducing gingival inflammation at the local site in addition to better esthetic outcomes.
