Efficacy of a mouthrinse containing Ardox-X® Technology on the inhibition of de novo dental plaque formation in vivo.

Maintaining an adequate low level of plaque through daily toothbrushing is often not feasible. Chemotherapeutic agents as an adjunct to mechanical plaque control would be valuable. Ardox-X® Technology has shown to be an effective inhibitor of bacterial growth in-vitro. Up to now in vivo data regarding the anti-microbial effects of Ardox-X® Technology mouthrinse are lacking.

The aim of the study is to evaluate the efficacy of Ardox-X® Technology on the inhibition of de novo plaque formation and changes in the microbial composition in periodontally healthy patients in a one-week non-brushing model.

Time point:

1. Screening;

2. Pre experimental;

3. Experimental;

4. Assesment.

Wash out:

1. Experimental;

2. Assesment.

This randomized controlled clinical trial takes 9 weeks total. The trial starts with a pre-experimental period of 7 days followed by two experimental weeks. Each experimental week subjects receive a professional dental prophylaxis preformed by dental hygienists.

For 2 experimental periods of 7 days, subjects are asked to refrain from brushing and interdental cleaning. Instead of their normal oral hygiene subjects rinse twice daily with a test or control mouthwash. Subjects receive instruction how to use the intervention products and rinse the first time under supervision. According randomization subjects are assigned to the control or test group. In the second experimental week subjects from the control group switch to the test group and vice versa (cross-over design). In the 3 weeks of 'wash-out' period, between the two experimental weeks, subjects resume their normal oral hygiene.