BACKGROUND: The objective of this pilot clinical trial was to evaluate the anti-gingivitis and anti-plaque effects of a dentifrice containing bioactive glass (NovaMin) compared with a placebo control dentifrice in a 6 weeks clinical study. METHODS: The study design was a randomized, double-blinded, controlled clinical trial. One hundred volunteers took part in the study and were matched for plaque index (PLI), gingival bleeding index (GBI), age and gender. The protocol was reviewed and approved by the Ethical Committee of the University. The subjects received a supragingival prophylaxis to remove all plaque, calculus and extrinsic stain. Following the baseline examination, subjects were instructed to brush with their assigned dentifrice and toothbrush. The PLI and GBI were determined for the baseline and 6 weeks. The data were analysed using a repeated-measures anova conducted on the two dependent measures to compare the effect between the test and control group. RESULTS:Ninety-five subjects finished the study. The results showed that the PLI (baseline=1.54, 6 weeks=1.29) and GBI (baseline=1.14, 6 weeks=0.47) were significantly reduced, respectively, over the 6 weeks period in the test group (p<0.001 for each measure). There was a 58.8% reduction in gingival bleeding and a 16.4% reduction in plaque growth. There was no difference of the PLI (baseline=1.60, 6 weeks=1.57) and GBI (baseline=1.18, 6-week=1.02) over the 6 week period in the control group. CONCLUSION: This study demonstrated that a dentifrice containing NovaMin significantly improves oral health as measured by a reduction in gingival bleeding and reduction in supragingival plaque compared with a negative dentifrice over the 6 weeks study period.
RCT Entities:
BACKGROUND: The objective of this pilot clinical trial was to evaluate the anti-gingivitis and anti-plaque effects of a dentifrice containing bioactive glass (NovaMin) compared with a placebo control dentifrice in a 6 weeks clinical study. METHODS: The study design was a randomized, double-blinded, controlled clinical trial. One hundred volunteers took part in the study and were matched for plaque index (PLI), gingival bleeding index (GBI), age and gender. The protocol was reviewed and approved by the Ethical Committee of the University. The subjects received a supragingival prophylaxis to remove all plaque, calculus and extrinsic stain. Following the baseline examination, subjects were instructed to brush with their assigned dentifrice and toothbrush. The PLI and GBI were determined for the baseline and 6 weeks. The data were analysed using a repeated-measures anova conducted on the two dependent measures to compare the effect between the test and control group. RESULTS: Ninety-five subjects finished the study. The results showed that the PLI (baseline=1.54, 6 weeks=1.29) and GBI (baseline=1.14, 6 weeks=0.47) were significantly reduced, respectively, over the 6 weeks period in the test group (p<0.001 for each measure). There was a 58.8% reduction in gingival bleeding and a 16.4% reduction in plaque growth. There was no difference of the PLI (baseline=1.60, 6 weeks=1.57) and GBI (baseline=1.18, 6-week=1.02) over the 6 week period in the control group. CONCLUSION: This study demonstrated that a dentifrice containing NovaMin significantly improves oral health as measured by a reduction in gingival bleeding and reduction in supragingival plaque compared with a negative dentifrice over the 6 weeks study period.
Authors: Xiaojing Chen; Xiaohui Chen; Delia S Brauer; Rory M Wilson; Robert V Law; Robert G Hill; Natalia Karpukhina Journal: Int J Appl Glass Sci Date: 2017-09-27 Impact factor: 2.029
Authors: Yann C Fredholm; Natalia Karpukhina; Delia S Brauer; Julian R Jones; Robert V Law; Robert G Hill Journal: J R Soc Interface Date: 2011-10-12 Impact factor: 4.118
Authors: Derek A Hoffman; Andrew E Clark; Wellington J Rody; Susan P McGorray; Timothy T Wheeler Journal: Prog Orthod Date: 2015-08-13 Impact factor: 2.750