Clinical Trial of Malodor and Gingivitis Effects of Combination Hygiene

Objectives: A randomized controlled trial was conducted to evaluate effects of combination oral hygiene on oral malodor and gingivitis, and to assess possible endpoint correlations.
Methods: The study targeted adult volunteers with appreciable malodor and gingivitis. Institutional review and informed consent were obtained, and subjects were assigned a regular anticavity dentifrice and manual brush for 1-week acclimation. Baseline measurements were collected, and subjects with moderate-to-extensive malodor and gingivitis were randomly assigned to combination oral hygiene regimen or a regular hygiene control group. The regimen group received a 0.454% SnF₂ dentifrice (Crest® Pro-Health™ Clinical Plaque Protection), a 0.07% CPC rinse (Crest Pro-Health), floss (Oral-B® Glide Pro-Health Clinical) and a crisscross manual brush (Oral-B Clinical Pro-Flex), while subjects in the control group received a 0.243% NaF dentifrice (Crest Cavity Protection) and manual brush (Oral-B Indicator). Test products were dispensed blinded to treatment in kits with instructions for use. After 1-week, oral malodor was assessed by trained judges using a 9-point hedonic scale, and gingivitis was measured independently by a trained examiner using a 4-point scale (Loe-Silness) to quantify bleeding sites.
Results: At baseline, the population (N=60) exhibited diversity in age (18-60), bleeding sites (32-135), and malodor (7-9). For malodor, Week 1 adjusted mean (SE) hedonic scores were 2.54 (0.24) and 7.99 (0.24) for the regimen and control groups, respectively, with treatments differing significantly (p<0.0001). For gingivitis, Week 1 adjusted mean (SE) bleeding sites were 14.3 (3.5) and 70.6 (3.5) in the regimen and control groups, again differing significantly (p<0.0001). Changes in malodor and gingival bleeding were well correlated (r=0.71, p<0.0001). Both treatments were well-tolerated.
Conclusions: One week use of a stannous fluoride dentifrice, cetylpyridinium chloride rinse, floss and crisscross brush yielded 68-80% reductions in oral malodor and gingival bleeding relative to regular oral hygiene.