Background

Goal of this in vivo prospective, randomized, controlled, double-blinded, cross over study was to compare the level of plaque control and gingivitis after use of a novel dental gel (test) vs. A Triclosan/copolymer dentifrice (control).

Methods

After coronal polishing, 22 subjects with moderate gingivitis were randomly assigned to brush twice daily with test or control dentifrice for the first study Arm. Plaque, gingival and sulcus bleeding indices were recorded at baseline, week 2 and week 4. Professional coronal polishing was repeated, and then subjects brushed with the second dentifrice for 4 weeks. Clinical indices were again recorded at Baseline, week 2 and week 4. The effects of each dentifrice on clinical indices were compared using Student's t-test.

Results

Brushing with the test gel produced significantly greater levels of plaque reduction versus the Triclosan/copolymer control dentifrice at each time point. 45% less plaque was measured after 4 weeks of test agent use than after control agent use (p<0.000000005). A significant reduction in gingival inflammation from test vs control agent over w weeks was also observed (p=0.000342).

Conclusions

An activated edathamil dental gel formulation provides effective plaque control and reduced gingival inflammation compared to a Triclosan/Co-polymer dental gel. Practical Implications: A novel dental gel formulation that does not contain abrasives, detergents or antimicrobials may provide effective plaque control and support gingival health.

Objectives

The goal of this clinical study was to determine the effects of a dental gel containing 2.6% edathamil on overnight plaque re-accumulation and plaque removal.

Methods

In this double-blind, randomized crossover study, 10 subjects first brushed for one week with a washout toothpaste. On the evening of Day 7, prior to tooth brushing, Plaque Index (PI) was recorded, then plaque stained and photographed. Subsequently subjects were randomized to either brush with the test dental gel or the control. After overnight plaque accumulation, PI was recorded. Plaque was stained and photographed before and after subjects brushed with the same toothpaste as the previous night. Subsequently, the process was repeated with the second toothpaste. Image J software was used to quantify plaque presence.

Results

Mean increase in PI overnight after brushing (1.78 versus 0.94) and final PI after tooth brushing the next morning (2.20 versus 1.31) were significantly (p < 0.05) better after use of the test gel. Tooth surface covered by plaque overnight was significantly higher after using the control gel (22.3%) than the test gel (11.8%; p < 0.05). After morning brushing, the residual area of plaque on the teeth was significantly higher for the control gel (9.2%) than for the test gel (3.6%; (p < 0.05).

Conclusions

A test dental gel more effectively reduced overnight plaque re-accumulation and achieved better plaque removal than a control dentifrice.