Randomized controlled trial evaluating periodontal health maintenance with combination hygiene

OBJECTIVES: A 24‐month randomized controlled trial was conducted to evaluate the effects of combination oral hygiene on periodontal health maintenance. METHODS: After institutional review, informed consent was obtained, and generally healthy adults in an Israeli kibbutz were screened for 16+ teeth, 20+ bleeding sites and 3+ pockets >3‐6 mm. After baseline measurements, subjects were stratified on PD, GBI, age, gender and smoking, and randomly assigned (1:1) to marketed combination oral hygiene or regular control products (all manufactured by The Procter & Gamble Co.). The combination oral hygiene group received SnF2+NaF dentifrice, oscillating/rotating power toothbrush, 0.07% cetylpyridinium chloride rinse and floss, while the negative control group received regular anti‐cavity dentifrice and a manual toothbrush. Prophylaxis was conducted at baseline and semi‐annually thereafter. Periodontal health was measured every 6 months via Gingival Bleeding Index (GBI), Modified Gingival Index (MGI) scores, number of bleeding sites (BS) and pocket depth (PD) in mm. Analyses were a priori and inclusive using ANCOVA at 5% significance levels. RESULTS: 107 subjects were enrolled, mean age was 47 (28‐64 years), 50% were female, 14% reported smoking, and 87 completed the 24‐month study. Relative to baseline, the combination group had significant (p<0.0001) improvements in gingival health beginning at Month 6 and continuing through Month 24. At Month 24, mean (SD) DBS was ‐19.4 (13.0) for the combination group and 3.7 (14.9) for the negative control. Adjusted mean (SE) PDs were 2.5 (0.03) and 2.9 (0.04) for the combination and control groups, respectively. Between‐group comparisons showed significantly (p<0.0009) lower BS (28‐39%) and lower PD (6‐13%) for the combination versus control depending on visit. CONCLUSIONS: In a randomized controlled trial, long term use of a stannous fluoride, oscillation‐rotation brush, rinse and floss during routine maintenance resulted in significant improvements in periodontal health (gingivitis and pocket depth) versus maintenance/hygiene alone.