OBJECTIVE: The objective of these three clinical trials was to compare the impact of two commercial products, Colgate Total and Crest Pro-Health, on the formation of dental plaque over a 24-hour period of time. The studies utilized the Modified Gingival Margin Plaque Index (MGMPI), a validated and reliable clinical method for assessing the efficacy of products in reducing plaque build-up. METHODS:Colgate Total and Crest Pro-Health were the test products for all three clinical trials. Colgate Great Regular Flavor (CR) was used as the universal washout product. Colgate Total, as the only toothpaste approved by the FDA under an NDA for antiplaque, antigingivitis, and anticaries benefits, contains 0.3% triclosan/2.0% PVM/MA copolymer for antigingivitis and antiplaque, as well as 0.243% sodium fluoride (NaF) for anticaries. Crest Pro-Health contains 0.454% stannous fluoride (SnF2) as both a monographed anticaries agent and a monographed antigingivitis agent, along with sodium hexametaphosphate and zinc lactate. Twenty-five healthy subjects meeting all study criteria were included into each of the double-blind studies. Product assignment was randomized and a crossover design was implemented. Informed consent was obtained from all subjects prior to commencement of each of the studies. The studies followed published MGMPI procedures, which require subjects to receive a dental scaling/prophylaxis followed by a one-week washout period prior to use of test products. A baseline MGMPI score was calculated following use of the test products in the dental clinic. Subjects refrained from all oral hygiene for 24 hours following use of each test product, and returned to the clinic for a 24-hour MGMPI score. Following a washout period, subjects repeated the procedure with the other test product as per the crossover design. The differences (delta) between baseline plaque scores and 24-hour plaque scores were independently calculated for each study, and the delta values were compared for the two test products in each of the studies. RESULTS: In all three clinical trials, Colgate Total significantly reduced plaque regrowth over a 24-hour time period (p < or = 0.05) compared to Crest Pro-Health. Existing differences were determined via a paired t-test, which confirmed that Colgate Total was statistically significantly different from Crest Pro-Health. CONCLUSION: These in vivo data support the antiplaque benefit of the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice. Additionally, the results support that Colgate Total provides superior efficacy in inhibiting the formation of dental plaque compared to Crest Pro-Health.
RCT Entities:
OBJECTIVE: The objective of these three clinical trials was to compare the impact of two commercial products, Colgate Total and Crest Pro-Health, on the formation of dental plaque over a 24-hour period of time. The studies utilized the Modified Gingival Margin Plaque Index (MGMPI), a validated and reliable clinical method for assessing the efficacy of products in reducing plaque build-up. METHODS: Colgate Total and Crest Pro-Health were the test products for all three clinical trials. Colgate Great Regular Flavor (CR) was used as the universal washout product. Colgate Total, as the only toothpaste approved by the FDA under an NDA for antiplaque, antigingivitis, and anticaries benefits, contains 0.3% triclosan/2.0% PVM/MA copolymer for antigingivitis and antiplaque, as well as 0.243% sodium fluoride (NaF) for anticaries. Crest Pro-Health contains 0.454% stannous fluoride (SnF2) as both a monographed anticaries agent and a monographed antigingivitis agent, along with sodium hexametaphosphate and zinc lactate. Twenty-five healthy subjects meeting all study criteria were included into each of the double-blind studies. Product assignment was randomized and a crossover design was implemented. Informed consent was obtained from all subjects prior to commencement of each of the studies. The studies followed published MGMPI procedures, which require subjects to receive a dental scaling/prophylaxis followed by a one-week washout period prior to use of test products. A baseline MGMPI score was calculated following use of the test products in the dental clinic. Subjects refrained from all oral hygiene for 24 hours following use of each test product, and returned to the clinic for a 24-hour MGMPI score. Following a washout period, subjects repeated the procedure with the other test product as per the crossover design. The differences (delta) between baseline plaque scores and 24-hour plaque scores were independently calculated for each study, and the delta values were compared for the two test products in each of the studies. RESULTS: In all three clinical trials, Colgate Total significantly reduced plaque regrowth over a 24-hour time period (p < or = 0.05) compared to Crest Pro-Health. Existing differences were determined via a paired t-test, which confirmed that Colgate Total was statistically significantly different from Crest Pro-Health. CONCLUSION: These in vivo data support the antiplaque benefit of the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice. Additionally, the results support that Colgate Total provides superior efficacy in inhibiting the formation of dental plaque compared to Crest Pro-Health.