6-Week Clinical Trial Comparing Combination Hygiene and Professional Care

Objective: This clinical trial compared the safety and effectiveness of combination oral hygiene (brush, paste, rinse, floss) or dental prophylaxis on clinical gingivitis. 

Method: After institutional review and informed consent, adults were evaluated for gingivitis, and enrolled subjects were randomly assigned to one of two interventions: combination hygiene (CH) or professional care plus routine hygiene (PC).  Whole mouth gingivitis was measured by a treatment-blinded examiner using a standard index (Loe-Silness Gingivitis Index).  Test products were dispensed in blinded kits.  The CH group received 0.454% stannous fluoride paste (Crest® Pro-Health Clinical Gum Protection) and a flexible crisscross manual brush (Oral-B® Pro-Health Clinical), 0.07% cetylpryidinium chloride rinse (Crest Pro-Health) and floss (Glide®), while the PC group received a thorough dental prophylaxis plus a regular anticavity paste and manual brush.  Daily treatment was unsupervised at-home, and subjects were evaluated biweekly over 6-weeks to assess change in gingivitis bleeding sites. 

Result: The study population (N=50) exhibited diversity with respect to age (18-50 years), ethnicity and bleeding sites (6-38 sites) at baseline.  The CH group had significant (p<0.01) improvement in gingivitis bleeding beginning at Week 2 and continuing through Week 6, while the PC group exhibited bleeding reductions at Week 2 that significantly (p<0.03) declined thereafter.  Overall, CH exhibited increasing improvement over time, with adjusted bleeding site means of 7.7, 5.1 & 2.2 at Weeks 2, 4 & 6, respectively, while in contrast, PC showed biweekly bleeding site means of 10.7, 13.2 & 15.5.  Groups differed significantly (p<0.008) beginning at Week 2 and continuing throughout the study.  A total of 46 subjects (23 per group) completed the study, and both treatments were well-tolerated. 

Conclusion: Use of a combination daily oral hygiene regimen involving a manual brush, floss plus a therapeutic paste and rinse resulted in significant (p<0.01) 80%+ improvements in gingivitis and bleeding relative to dental prophylaxis and routine hygiene.