Evaluating efficacy of a novel dentifrice in reducing probing depths in Stage I and II periodontitis maintenance patients: A randomized, double-blind, positive controlled clinical trial.

BACKGROUND: Compliance to periodontal maintenance therapy (PMT) is essential for long-term periodontal health. Between PMT visits, patients must maintain good oral hygiene. A dentifrice with demonstrable clinical benefits for use between PMT visits would be highly desirable. The aim of this clinical study was to investigate the effect of a novel dental gel on probing depths (PD) and inflammation when used as a home care dentifrice in Stage I and II periodontitis patients. METHODS: This double-blind clinical study randomized 65 subjects with Stage I and II periodontitis to the novel dental gel containing 2.6% EDTA, and a commercially available anti-gingivitis dentifrice with 0.454% stannous fluoride. Primary endpoint was PD at 6 months for those sites with baseline PD ≥ 4 mm and secondary endpoints included whole mouth mean scores of modified gingival index (MGI), modified sulcus bleeding index (mSBI) and plaque index (PI). No SRP was performed at baseline. RESULTS: Subjects using the novel dentifrice showed significant PD reductions of 1.18 mm (from 4.27 mm at baseline to 3.09 mm at 6 months) compared to 0.93 mm (from 4.23 mm at baseline to 3.30 mm at 6 months) shown for those using the positive control dentifrice. Difference between treatments at 6 months was 0.21 mm with P-value = 0.0126. Significant improvements in MGI (P = 0.0000), mSBI (P = 0.0000), and PI (P = 0.0102) were also observed in 6 months. CONCLUSION: The novel dentifrice showed significant reductions in PD and gingival inflammation over 6 months solely as a home care dentifrice without baseline SRP in Stage I and II periodontitis maintenance patients.

Effects of a Dental Gel Over 6 Months on Periodontal Health in Subjects with Stage II and III (Mild and Moderate) Periodontitis.

OBJECTIVE: Overall aim of this prospective, randomized, positive controlled, double-blind in vivo study was to identify the effects of a test dental gel containing 2.6% edathamil with an added carrier and permeability enhancer vs. a positive control dentifrice on periodontal health measures in patients with Stage II and III periodontitis. METHODS: In this prospective double-blinded, randomized study, 33 subjects were randomly assigned in a 1:1 ratio to brushing their teeth with either the test gel (LivFresh®, Livionex Dental Gel, Los Gatos, CA 95030) or the positive control toothpaste (Crest ProHealth®, P&G, Cincinnati, OH 45202).Full-mouth gingival index, modified sulcus bleeding index, and periodontal pocket probing depths were recorded for all teeth at baseline, and on days 90 and 180.Subjects brushed with the study material twice a day. RESULTS: The test dental gel reduced gingival inflammation and bleeding, as well as periodontal pocket probing depths significantly more than a control dentifrice. CONCLUSIONS: In this pilot study in subjects with Stage II and III periodontitis, a test dental gel was found to improve gingival inflammation and bleeding, as well as periodontal pocket depths significantly better than a control dentifrice.