Summary human studies:
Initial studies - open pilot studies
- Nordlund: 22 participants. Statistical and clinical significant reduced effect on plaque, tartar and gingival bleeding after 10 weeks. Main effect was seen after the first 5 weeks of supplementation.
- Mattsson & S Wikner: 30 participants. Extension of plaque and calculus was strongly and significantly reduced after 2 months, with 46 and 81% reduction, respectively.
Controlled parallel study
- Wikner: 40 participants with no oral hygiene and 103 participants with oral hygiene. In the no oral hygiene group getting ProDen PlaqueOff® plaque was reduced with 44,4% while in the placebo group it was increased with 69,2%. In the group with oral hygiene the corresponding figures were a reduction with 83,3 in the PlaqueOff® group and with 18,8% in the placebo group.
Controlled randomized cross-over designed study
- J van Dijken: 61 participants. A highly significant reduction of supragingival calculus, and a significant less bleeding on probing and plaque was seen in the active group compared to the control. 52 out of 55 participants showed a lower calculus formation in the active group with a mean calculus reduction score/site of 52%.
Double blind, randomised, placebo controlled study. Dose response
- Wikner, C. Timander and J. Bergström: 105 participants. Significant reduction on plaque levels compared to control were observed after eight weeks in both low and high dose algal groups with 49% and 66% reduction, respectively. Significant reduction in supragingival calculus levels were observed after four weeks and improving after eight weeks. The effect appears to be dose dependent. Significant drop of S. mutants in active groups
All human studies showed a consistent and significant reducing effect on calculus and plaque of ProDen PlaqueOff® compared to a control and/or after treatment compared to baseline. A dose-response effect was indicated.