1 A 6-Month Study of the Effects of a 0.3% Triclosan/Copolymer Dentifrice on Dental Implants PK Sreenivasan1, Y Vered2, A Zini2, J Mann2, H Kolog2, D Steinberg2, JJ Zambon3, VI Haraszthy3, MP da Silva3, W DeVizio1 J Clin Periodontol: In Press 1 Clinical Dental Research, Colgate-Palmolive Company, Piscataway, NJ, USA 2 Hadassah School of Dental Medicine, Hebrew University, Jerusalem, Israel 3 School of Dental Medicine, University at Buffalo, Buffalo, NY, USA Study objective The objective of this study was to evaluate the clinical and microbiological effects of routine oral hygiene with a triclosan/copolymer toothpaste on dental implants and natural teeth compared with a fluoride control toothpaste. Trial conditions and methods Products under investigation Test dentifrices: 0.3% triclosan/2% copolymer, 1100 ppm fluoride as NaF (Colgate-Palmolive Company, New York, NY). Control dentifrice: 1450 ppm fluoride as MFP (Colgate-Palmolive Company, New York, NY). Study subjects 120 adult subjects (56 males and 64 females) in good oral and general health, 18 years of age or over, with at least 20 teeth and at least one dental implant were included in this study. Methods In this 6-month, double-blind, two-treatment, parallel group study, 60 subjects were randomly assigned to a triclosan/copolymer dentifrice group, and 60 subjects to a fluoride dentifrice control group. Subjects were provided a soft-bristled toothbrush and instructed to brush twice daily with their assigned toothpaste for the next 6 months. At baseline, 3, and 6 months, a calibrated dentist examined subjects for dental plaque, gingival index, and bleeding on probing and collected supragingival plaque from both the dental implants and contra-lateral natural teeth for laboratory testing. Analysis of the clinical variables was conducted on an ‘‘intention-to-treat’’ (ITT) basis with the subject as the statistical unit. ITT included all measured sites from all 120 subjects enrolled in the study with analyses conducted in accordance with randomized treatment assignment and statistical significance reported at p<0.05. Primary outcomes were clinical measures of plaque and gingival inflammation and secondary outcomes were microbiological changes. YOUR PARTNER IN ORAL HEALTH www.colgateprofessional.com plaque scores onplaque naturalscores teeth and dental implants theimplants durationover of the study. Dental on natural teeth andover dental the duration of the study. Results and discussion 2 Results Dental plaque scores on natural teeth and dental implants over the duration of the study. al plaque scores on natural teeth over the duration of group the study. 105 subjects completed theand study.dental Subjectsimplants in the triclosan/copolymer dentifrice demonstrated significantly lower levels of dental plaque and gingival inflammation 3the study. al plaque scores on natural teeth and dental implants over the duration ofthe Dental plaque scores on natural teeth and dental implants overat duration of the study. and 6 months for both the dental implants and contra-lateral natural teeth compared with the fluoride dentifrice group (p<0.05), as shown in the following charts: Plaque Scores Control Teeth Plaque Scores Dental Implants 2.5 Dental plaque scores on natural teeth and dental implants over the duration of the study. Dental plaque scores on natural teeth and dental implants over the duration of the study. 2.5 Plaque Index (Mombelli Index) Plaque Index (Silness and Loe) Dental plaque scores on natural teeth and dental implants over the duration of the study 2 2 1.5 l index scores on natural teeth and dental implants over theimplants durationover of the study. Gingival index scores on natural teeth and dental the duration of the study. 1 1.5 1 .5 0 Baseline 3 months Baseline 3 months 6 months Gingival scores on6 months natural teeth andover dental over duration of the study. ival index scores on index natural teeth and dental implants the implants duration of thethe study. Triclosan/copolymer Control Gingival index scores on natural teeth and dental implants over the duration of the study. Gingival Inflammation Control Teeth Gingival Inflammation Dental Implants Gingival index scores on natural andon dental implants over the duration the study. 2 Dental plaqueteeth scores natural teeth and dental implantsofover the duration of the study. Dental plaque scores on natural teeth and dental implants over the duration of the study. Gingival Index ( Loe Silness Index) Gingival Index (Loe Silness Index) Gingivalon index scores onteeth natural teeth and dental implants the duration of the study Gingival index scores on natural teeth andover dental implants overofthe val index scores natural and dental implants over the duration theduration study. of the study. 2 1.6 1.2 1.6 1.2 .8 .8 g on probing scores on natural teeth and dental implants over the duration of the study. Baseline 3 months 6 months Bleeding onBaseline probing scores natural teeth and dental implants over the duration of the study 3 months 6on months Triclosan/copolymer Control Bleeding on probing scoresBleeding on natural andscores dental on implants theand duration the study onteeth probing naturalover teeth dentalof implants over the duration of the study. index scores on and natural teeth and dental overofthe Bleeding on probingGingival scores on natural teeth dental implants overimplants the duration theduration study. of the study. Bleeding onnatural Probing Control Teeth Bleeding onover Probing Dental Implants Gingival index scoresscores on natural teeth and dental implants thethe duration of the study. ding on probing scores teeth and dental implants over duration of thethe study. Bleeding onon probing on natural teeth and dental implants over duration Dental plaque scores on1.2 natural teeth and dental implants over the duration of the study. of the s 1.2 Dental plaque scores on natural teeth and dental implants over the duration of the study. BOP Scores BOP Scores Bleeding on probing scores on natural .8 teeth and dental implants over the duration of the s .8 ding on probing scores on natural teeth and dental implants over the duration of the study. .4 .4 0 Baseline Triclosan/copolymer 3 months 6 months 0 Baseline 3 months 6 months Control Bleeding on probing scores ondemonstrated natural teeth and dental implants over the duration of the study. Furthermore, the triclosan/copolymer dentifrice group significant Bleeding on probingGingival scores on natural teeth dental implants overimplants the duration the study. of the study. index scores on and natural teeth and dental overof the duration reductions in the number of on anaerobic and aerobic bacteria on over boththe theduration dental of the study. Gingival index scores natural teeth and dental implants implants and the contra-lateral natural teeth at both 3 and 6 months (p<0.05). There were significantly fewer Gram-negative anaerobes in the triclosan/copolymer dentifrice group (p<0.05) including >90% reductions in Aggregatibacter actinomycetemcomitans, Campylobacter rectus, Eubacterium saburreum, Fusobacterium nucleatum, Porphyromonas gingivalis, Prevotella melaninogenica, Solobacterium moorei, and Tannerella forsythia versus a fluoride control toothpaste Conclusions Twice daily use of a 0.3% triclosan/2% copolymer toothpaste may enhance dental implant maintenance by reducing dental plaque and gingival inflammation. Bleeding on probing scores on natural teeth and dental implants over the duration of the study. Bleeding on probing scores on natural teeth and dental implants over the duration of the study. YOUR PARTNER IN ORAL HEALTH © 2010 Colgate-Palmolive Company, New York, NY 10022, USA www.colgateprofessional.com