Clinical Trial Comparing Plaque Effects of Hygiene Regimen or Prophylaxis

Objectives: A randomized clinical trial compared the effects of a daily oral hygiene combination regimen on overnight plaque accumulation versus a dental prophylaxis.
Methods: After IRB approval and informed consent, baseline measurements were obtained, and subjects with overnight plaque were randomized equally to a daily oral hygiene regimen or dental prophylaxis (the positive control). The regimen group received an advanced manual crosscross brush, 0.454% stannous fluoride dentifrice, 0.1% CPC rinse and floss, while the control group received a dental prophylaxis plus a 0.243% sodium fluoride dentifrice and manual brush. Test products (The Procter & Gamble Co.) were dispensed in blinded kits for 7-days at-home use, while subjects assigned to the positive control also received a routine dental prophylaxis. Efficacy was measured instrumentally via image analysis of fluorescein-disclosed plaque coverage from high-resolution images of the anterior facial dentition, while safety was assessed from clinical examination.
Results: 47 subjects were randomized, mean (SD) age was 36.7 (13.6) years, and 46 were evaluated at Day 7. At baseline, mean (SD) overnight plaque area % coverage was 14.1 (10.6) and 14.2 (14.4) in the regimen and control groups, respectively. Relative to baseline, only the oral hygiene regimen group exhibited a significant (p=0.0002) improvement in overnight plaque area at the 1-week recall. Adjusting for baseline, Week 1 means (SE) for overnight plaque area % coverage were 5.19 (0.68) and 12.08 (1.69) in the regimen and prophylaxis groups, respectively. This represented a 57% reduction in plaque with the regimen versus the positive control, with groups differing significantly (p<0.0005). Both treatments were well-tolerated.
Conclusions: Use of a combination daily oral hygiene brush, paste, rinse and floss regimen resulted in significant improvement in overnight plaque accumulation in one week relative to a dental prophylaxis, and as such, may represent a useful approach to achieve sustained plaque control.