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Fotinos S. Panagakos, DMD, PhD, Diane Cummins, PhD
ABSTRACT
This article reviews evidence of the clinical effectiveness and mechanism of action of Colgate* Total*.
Thirteen independent, 6-month plaque and gingivitis studies have demonstrated plaque and gingival bleeding reductions in the range of 12% to 98% and 38% to 88%, respectively, for Colgate* Total*. Six 3- to 6-month calculus studies have shown tartar reductions in the range of 23% to 55%. Four 2- to 3-year caries studies have demonstrated the effectiveness of the fluoride ingredient, one showing a reduction in new cavities of 16.6% with the addition of the triclosan copolymer system over fluoride alone. In addition, three 3-week organoleptic studies have shown reductions in oral malodor, 12 hours after brushing with Colgate* Total*, in the range of 40% to 53%. Colgate* Total* has also been shown to provide clinical benefits in reducing the progression of established periodontal disease.
In situ plaque viability studies have shown that significantly less viable bacteria were present in dental plaque collected 12 hours after brushing with Colgate* Total* compared with plaque collected 12 hours after brushing with a regular fluoride dentifrice. The effects of Colgate* Total* on clinical plaque scores and on levels of representative organisms in harvested plaque, 24 hours postbrushing, were compared to the effects of regular fluoride toothpaste. Colgate* Total* showed a 41% reduction in dental plaque coverage and fewer periodontal pathogens and early colonizers in harvested plaque compared to control. In vitro studies have demonstrated that triclosan has the potential to suppress a number of cytokine-initiated inflammatory pathways contributing to gingival inflammation This is consistent with in vivo studies that show that Colgate* Total* can directly reduce gingival inflammation in addition to its effects on plaque bacteria.
In summary, clinical studies have demonstrated that Colgate* Total* delivers superior oral health benefits compared to regular fluoride toothpaste, including the prevention and control of plaque and gingivitis, reduced formation of calculus and oral malodor, and caries prevention. Colgate* Total* also provides benefits in preventing and controlling the progression of periodontal disease. Clinical and laboratory studies also show that Colgate* Total* provides 12-hour antibacterial protection and anti-inflammatory action, as well as 24-hour protection against plaque.
This article reviews some of the unique properties and characteristics of Colgate* Total* toothpaste. A short background is followed by the mechanism of action, which covers both the antibacterial as well as the anti-inflammatory effects of Colgate* Total*. A summary of clinical studies is presented, including the documented clinical effects of Colgate* Total* on periodontal disease.
BACKGROUND
Colgate* Total* is a uniquely formulated dentifrice that possesses pronounced antibacterial and anti-inflammatory properties. The dentifrice formulation contains 0.3% triclosan and 2% of PVM/MA copolymer in a 0.243% sodium fluoride base. Triclosan is a broad-spectrum antibacterial agent marketed for use in oral products under the trade name Irgacare MP® (Ciba-Geigy corporation).1 The chemical name is 2,4,4'-trichloro-2'- hydroxydiphenyl ether (Figure 1).
Triclosan is a useful antibacterial agent to incorporate into oral care products because it has a broad spectrum of activity against oral bacteria, is compatible with the ingredients in oral care products, and has a long history of safe use in consumer products.2 After review of the available pharmacological and toxicological data, it was concluded that triclosan is safe for use in dentifrice and mouthrinse products.3 Subsequently, a number of additional studies and reviews have attested to the safety of triclosan.4-7
PVM/MA is the nonproprietary designation for a polyvinylmethyl ether maleic acid copolymer. The chemical structure of this copolymer is presented in Figure 2. The results of in vitro studies reported showing greater uptake of triclosan to enamel and buccal epithelial cells for a fluoride dentifrice containing both triclosan and the PVM/MA copolymer compared with a dentifrice containing triclosan alone. It was also reported that the PVM/MA copolymer, in the presence of triclosan, inhibited crystal growth in vitro and in vivo8,9 and a US patent on the triclosan and PVM/MA copolymer technology in oral products was granted.10
Colgate* Total* has been approved by the US Food and Drug Administration (FDA) as the only over-the-counter (OTC) oral care product that is clinically proven to reduce plaque and gingivitis. It has also been demonstrated to provide clinical benefits in preventing cavities and in controlling calculus and oral malodor.
More than 40 controlled clinical studies have demonstrated the efficacy of Colgate* Total* vs regular fluoride dentifrices. Thirteen independent, 6-month plaque and gingivitis studies have demonstrated reductions in plaque and gingival bleeding in the range of 12% to 98% and 38% to 88%, respectively.11-23 Six calculus studies, 3 to 6 months in duration, have shown tartar reductions in the range of 23% to 55%.24-29 Four caries clinical studies, ranging between 24 and 36 months, have demonstrated the effectiveness of the fluoride ingredient and, in one study, showed a reduction in the development of new cavities of 16.6%.30-33 The caries studies demonstrated that Colgate* Total* is equal to or better than other dentifrices, containing the same type and level of fluoride, in promoting anticavity effects. Three organoleptic studies, and one study of volatile sulphur compounds (VSC), have shown reductions in oral malodor in the range of 40% to 53%, up to 12 hours after brushing with Colgate* Total*.34-37 In conjunction with these oral malodor studies, investigation of the tongue and saliva microflora showed that Colgate* Total* has a pronounced effect in reducing the bacteria that produce VSC (the compounds that cause oral malodor).38 No adverse effects on oral soft tissue or hard tissue resulting from the use of Colgate* Total* were observed in any of these clinical studies.
In addition to these clinical studies, microbiological safety studies have been conducted to examine the effects of *Colgate Total* on oral ecology. Five studies were conducted, ranging in length from 6 to 12 months, in which the use of Colgate* Total* was compared to regular fluoride dentifrice. No differences in the presence or proportion of bacterial species were observed; no overgrowth of opportunistic bacteria, periodontal pathogens, or cariogenic flora was noted; and no bacterial resistance to triclosan was seen in these five studies.39-43
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© Colgate Oral Pharmaceuticals
