| Abstrakt: |
Tlie objective of this study was to evaluate the effectof different interdental oral cleaning modalities on gingivitis and plague following a 6-week period of home use. This was a randomized, four-arm, parallel design clinical trial. Study subjects were manual toothbrush (MTB) users with moderate to severe gingivitis, aged 18 to 65 years. Subjects were required at baseline to have a gingival bleeding score of -1 on at least 50 gingival sites per the Gingival Bleeding I ndex (GBI) and to have an overall plague score of 20.6 per the Rustogi Modified Navy Plague Index (RMNPI) following a 3- to 6-hour plague accumulation period. Subjects were randomly assigned to use one offouroral caircleaning niodalities: (1) NON group: MTB alone, (2) FLS group: MTB plus string floss, (3) IDB group: MTB plus an interdental brush, or (4) CPF group: MTB plus the Philips Sonicare Cordless Power Flosser with the Quad Stream nozzle. Efficacy measures (Modified Gingival Index [MGIl, GBI, and RMNPI) and safety were assessed at baseline. 2 weeks, and 6 weeks. The primary efficacy endpoint was the reduction in gingival inflammation from baseline to week 6 as ineasilred by the MG L Of the 372 subjects r:indomized in the study, 364 completed a post-baseline MGI evaluation and were included in the analyses. The adjusted mean percent reduction in gingival inflamniation from baseline to week 6 was -2.10% for the NON group, 2.82% fur the FLS group, 2.60% forthe IDB group, and 29.10% for the CPF group. Pairwise comparisons indicated that the CPF group was statistically significantly different from the NON, FLS, and IDB groups Of' < .0001). In conclusion, adjunctive use ofthe Philips Sonicare Cordless Power Flosser with the Quad Stream nozzle and an MTB showed statistically better results in term of reducing gingival inflammation following 6 weeks o f home use when compared to an MTB alone, an MTB used with string floss, and an MTB used With an interdental brush. [ABSTRACT FROM AUTHOR] |
