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
Download

Clinical Efficacy of ColgateTotal ® Toothpaste on Peri