1 Clinical Efficacy of Colgate Total® Toothpaste on Peri-Implant Mucositis in Dental Implant Patients P. Ramberg, J. Lindhe, D. Botticelli, A. Botticelli The Effect of a Triclosan Dentifrice on Mucositis in Subjects with Dental Implants: A Six-Month Clinical Study In: Journal of Clinical Dentistry (2009), 20: 103-107 Study Objectives The objective of this 6-month clinical study was to compare the effects of the use of a dentifrice containing triclosan/copolymer and a regular fluoride dentifrice on peri-implant mucositis in subjects that had been restored with dental implants. Trial Conditions and Methods Products Under Investigation Test: Colgate Total® toothpaste containing 0.3% triclosan/2.0% copolymer/ 0.243% sodium fluoride (Colgate-Palmolive Company, New York, USA) Control: Colgate® Cavity Protection toothpaste containing 0.76% sodium monofluorophosphate (Colgate-Palmolive Company, New York, USA) Study Subjects A total of sixty male and female subjects (aged 35-70) who had lost teeth due to periodontal disease and had been restored with a minimum of two implants at least 1 year prior to the start of the study with a minimum of one implant site showing signs of peri-implant mucositis. Methods This trial was designed as a double-blind, randomized, two treatment, parallel group clinical study. Following baseline evaluations for bleeding on probing (BoP), probing pocket depth (PPD), and plaque at the mesial, distal, buccal, and lingual sites of all implants present, the subjects were randomly assigned to either the test or the control group. Subjects were instructed to brush twice daily (morning and evening) for 1 minute each time with their assigned dentifrice and a commercially available soft-bristled toothbrush for the six-month duration of the study. Clinical parameters (BoP, PPD, plaque) were determined after three and six months and statistically analyzed using ANOVA (changes from baseline) and ANCOVA (differences between groups). YOUR PARTNER IN ORAL HEALTH www.colgateprofessional.com Results and Conclusion 2 Results Fifty-nine subjects1 with a mean age of 57 years (± 8 yrs) completed the clinical trial. Subjects who used the test toothpaste exhibited significantly less inflammation than those who used the regular fluoride dentifrice. Mean BoP scores in the test group were significantly (p<0.001) reduced at both 3 months (-30.9%) and 6 month (-24.7%) compared to the baseline, whereas the control group showed no significant change. Furthermore, the mean change in BoP in the test group between baseline and 6 months was significantly different from the change in the control group (Fig. 1). Mean % of implant sites with BoP Bleeding on Probing 60 Colgate® Total Control 50 40 30 * * 20 + 10 0 -10 -20 -30 Baseline 3 Months 6 Months BL-6M Fig. 1: Mean percentage of implant sites with bleeding on probing (BoP) at baseline (BL), 3 months and 6 months, and mean change between baseline and 6 months. Mean changes between BL and 3 months and BL and BL and 6 months were statistically significant in the group using Colgate Total® (* p<0.001). The mean BoP change in the test group between BL and 6 months was significantly different from the change in the control group (+ p<0.001). Furthermore, the individual mean probing pocket depth, as well as the frequency of sites with 5mm and ≥6mm deep pockets, were reduced significantly more in the group using Colgate Total® than in the control group (data not shown). Conclusions The results of this six-month clinical trial comparing the use of Colgate Total® toothpaste and a regular fluoride dentifrice in subjects with peri-implant mucositis indicate that the regular use of Colgate Total® toothpaste may reduce the signs of inflammation in the mucosa adjacent to dental implants. 1. One subject left the study for reasons unrelated to the trial. YOUR PARTNER IN ORAL HEALTH © 2010 Colgate-Palmolive Company, New York, NY 10022, USA www.colgateprofessional.com