Crossover Clinical Trial of Tablets Containing Sodium Tripolyphosphate on Dental Stain Formation.

OBJECTIVES: The purpose of this clinical investigation was to evaluate the effectiveness of sugar-free tablets containing sodium tripolyphosphate 2% or sodium tripolyphosphate 0.65%, compared to a no-tablet control in preventing the formation of extrinsic stains over a 12- week period of regular unsupervised use preserving daily oral hygiene with dentifrice and usual tooth brushing. METHODS: This was a single-center, examiner-blind, randomized, 12-week crossover clinical trial. Sixty-six adult participants were enrolled in the study and were submitted to a professional cleaning to have a stain-free baseline. They either consumed two sugar-free tablets four times per day or not for 12 weeks. At the crossover, all procedures were repeated and subjects were assigned to another group. Extrinsic stain was measured at each 12-week period by the Modified Lobene Stain Index (MLSI). RESULTS: After the three legs of 12 weeks, 60 subjects completed the trial, their MLSI stain scores showed a significant 35.5% reduction (p < 0.001) in new stain formation for those using the sodium tripolyphosphate 2% tablets, and a significant 23.3% reduction (p < 0.001) in new stain formation for those using the sodium tripolyphosphate 0.65% tablets versus the control group. CONCLUSIONS: This clinical study showed that regular use of sugar-free tablets added with sodium tripolyphosphate 2% or 0.65% can reduce stain formation on the anterior teeth respectively by 35.5% (p < 0.001) or 23.3% (p < 0.001), both on facial and lingual/palatal surfaces.

Effect of Green Tea-Added Tablets on Volatile Sulfur-Containing Compounds in the Oral Cavity.

OBJECTIVES: A controlled, clinical, double-blind, cross-over study was conducted to assess the efficacy of sugar-free tablets containing green tea extract on oral volatile sulfur-containing compounds (VSC) versus placebo tablets for 30 minutes. METHODS: To join the study, subjects had to have at least 24 teeth, no report of oral and systemic diseases, and no removable dentures. All eligible participants had to avoid professional oral hygiene and drugs for two weeks, to not be menstruating, to avoid brushing their teeth and tongue, to not smoke, to not consume alcohol, coffee or tea, nor onion, garlic, or licorice for six hours before the test. Moreover, they had to score a level of VSC ≥ 75 ppb at the basal measurement. Subjects were entered into their respective groups after a minimum 48-hour wash-out period. The test tablet (0.7 g) contained 0.05% green tea extract (equivalent of 1 mg polyphenols for three tablets); the control tablet was identical but without the active agent. The OralChroma2™ device was utilized to evaluate VSC in the oral air. The levels were recorded at baseline, after sucking three tablets in succession, and after 30 minutes. Data were analyzed with SPSS software and significance was set at α = 0.05. RESULTS: 54 subjects completed the trial (23 men, 31 women). None reported problems linked to green tea. The mean reductions in VSC level from baseline at the end of tablet sucking were 34% (p < 0.001) in the control and 55% (p < 0.001) in the test group; after 30 minutes, reductions were 7% in the control (p = NS) and 26% (p < 0.005) in the test group. The comparisons between the two groups after baseline adjustment showed a statistically significant difference in reductions both at the end of the sucking period (p < 0.01) and after 30 minutes (p < 0.01). CONCLUSIONS: Tablets containing green tea extract can statistically significantly reduce the oral VSC levels immediately, and after 30 minutes. Moreover, the test tablets reduced oral VSC significantly more than the control tablets.

A clinical study of the efficacy of a new chewing gum containing calcium hydroxyapatite in reducing dentin hypersensitivity.

OBJECTIVE: A controlled, clinical, double blind study was conducted to assess the efficacy of a sugar-free chewing gum containing calcium hydroxyapatite on dentin hypersensitivity, versus a placebo chewing gum with no active ingredients, after one and two weeks. METHODS: One hundred and seven subjects joined the trial and were allocated into the test or the control (placebo) group by a random table. The test chewing gum contained calcium hydroxyapatite and dicalcium phosphate dihydrate; the control chewing gum was identical, but without those ingredients. Participants were required to chew two pieces of their assigned chewing gum three times a day. Dentin hypersensitivity was evaluated following three clinical test indexes (tactile, air blast, cold water) and one subjective index. RESULTS: One hundred subjects completed the study with 50 allocated to each group. The clinical test index reductions after one and two weeks in the test group were, respectively, 36% and 54% for tactile, 35% and 66% for air blast, and 24% and 49% for cold water. The clinical test index reductions after one and two weeks in the control group were, respectively, 16% and 30% for tactile, 11% and 25% for air blast, and 14% and 31% for cold water. These reductions at one and two weeks were significant for the test group (p < 0.01). For the control group they were significant (p < 0.01) only at two weeks. The comparisons between the groups at two weeks showed a significant statistical difference between the test and the control gum for tactile (p < 0.01), for air blast (p < 0.001), for cold water (p < 0.05), and for the subjective index (p < 0.05). CONCLUSION: In this trial, the group using the chewing gum containing calcium hydroxyapatite had a statistically significant reduction in all clinical test indexes for dentin hypersensitivity after one and two weeks, and a statistically significant reduction compared to the control gum group.

The effect of zinc lactate and magnolia bark extract added tablets on volatile sulfur-containing compounds in the oral cavity.

OBJECTIVE: A controlled, clinical, double-blind study was conducted to assess the efficacy of sugar-free tablets containing zinc lactate and magnolia bark extract (MBE) on oral volatile sulfur-containing compounds (VSC) versus placebo tablets for two hours. METHODS: In order to join the study, subjects had to have at least 24 teeth, no report of oral and systemic diseases, and no removable dentures. All 128 eligible participants had to avoid any professional oral hygiene, refrain from taking medicines for two weeks, be not menstruating, and not brush their teeth and tongue, smoke, drink alcohol, coffee or tea, eat onion, garlic, or licorice for a six-hour period before the visit and during the test. Moreover, to join the protocol, they had to show a VSC score of ≥ 75 ppb at the baseline measurement. Each qualified subject was placed in the test or the control group using a table of random numbers. The test tablet (0.7 g) contained 0.17 mg of zinc, in the form of zinc lactate, and 0.84 mg magnolia bark extract; the control tablet was identical, but without these active agents. The OralChroma2 device was utilized to evaluate total oral VSC. Their levels were recorded at baseline, after eight minutes of sucking two tablets in succession, after one hour, and after two hours. Data were analyzed with SPSS software and the level of significance was set at α = 0.05. RESULTS: One hundred subjects completed the trial (50 in the control group and 50 in the test group); 52 men and 48 women, mean age 38. None reported problems linked to zinc lactate or magnolia bark extract. The mean percentage reduction from baseline at the end of eight minutes of tablet sucking was 39% in the control group (p < 0.001) and 62% in the test group (p < 0.001); one hour later it was 6% in the control group and 30% in the test group (p < 0.001), and two hours later it was 2% in the control group and 18% in the test group (p < 0.001). The comparisons between the two groups after baseline adjustment showed a statistically significant difference in reductions of VSC between the test and the control tablets at the end of the sucking period (p < 0.01), after one hour (p < 0.001), and after two hours (p < 0.05). CONCLUSION: Tablets containing zinc lactate and magnolia bark extract can statistically significantly reduce the oral VSC levels for over two hours and were statistically significantly more effective than a control tablet.

The effect of zinc acetate and magnolia bark extract added to chewing gum on volatile sulfur-containing compounds in the oral cavity.

OBJECTIVE: A controlled, clinical, double-blind study was conducted to assess the efficacy of a sugar-free chewing gum containing zinc acetate and magnolia bark extract (MBE) on oral volatile sulfur-containing compounds (VSC) versus a placebo sugar-free chewing gum for two hours. METHODS: To participate in the study, subjects had to have at least 24 of their teeth, no report of oral and systemic diseases, and no removable dentures. All 168 eligible participants had to avoid any professional oral hygiene, refrain from taking medicine for two weeks, and not be menstruating. They were also instructed not to brush their teeth and tongue, smoke, drink alcohol, or eat onion, garlic, or licorice for the six-hour period before the visit and during the test. Moreover, to join the protocol, they had to show a VSC score of > or = 75 ppb at the baseline measurement. One-hundred and twenty-three subjects (67 men and 56 women, mean age 37) met the criteria at baseline and were entered into either the test or control group by assignment from a table of randomized numbers. The test chewing gum (2.23 g) contained zinc acetate 0.012% and magnolia bark extract 0.15% in weight; the control gum was equivalent without these active agents. The OralChroma device was utilized to evaluate total oral VSC. Their levels were recorded at baseline, after ten minutes of mastication, after one hour, and after two hours. Data were analyzed with SPSS software and the level of significance was set at alpha = 0.05. RESULTS: One-hundred and twenty-three subjects completed the trial (62 in the control group and 61 in the test group); none reported problems linked to zinc acetate or magnolia bark extract. The mean percentage reductions from baseline at the end of the 10-minute chewing were 31.2% in the control group (p < 0.05) and 50.9% in the test group (p < 0.05). One hour later the reductions were 6.9% in the control group and 27.6% in the test group (p < 0.05); two hours later the reductions were 2.3% in the control group and 13.6% in the test group. The comparison of the two groups after baseline adjustment showed a statistically significant difference (p < 0.05) in VSC reductions between the test and control chewing gums at the end of the mastication period and after one hour. CONCLUSION: Chewing gum containing zinc acetate and magnoliabark extract can significantly reduce the oral VSC levels for more than one hour. Moreover, the test chewing gum reduces oral VSC significantly more than a control chewing gum.

Effect on dental stain occurrence by chewing gum containing sodium tripolyphosphate--a double-blind six-week trial.

OBJECTIVE: A six-week controlled double-blind clinical study was conducted to assess and to measure the efficacy of a sugar-free chewing gum containing sodium tripolyphosphate (1%) on dental stain occurrence versus a placebo sugar-free chewing gum. METHODS: One-hundred and eleven subjects who had a Lobene Modified Index for stain extent score between 0.33 and 1.5 in their frontal teeth joined this study. Each subject entered in the test or the control group using a random table which allowed for an equal distribution of smokers and habitual tea users. Participants agreed to chew two gums (two grams each) three times per day, after meals, for ten minutes over six weeks. All received the same dentifrice containing only fluoride as the active agent. After six weeks, participants were scored for dental stain with the Lobene Modified Index. Data were scored by the same blinded operator for all measurements. Comparisons between the groups with respect to baseline scores were performed using an unpaired t-test, and inside the groups with a paired t-test (alpha = 0.05). RESULTS: One-hundred and eight subjects completed the trial; three left, but none reported problems linked to sodium tripolyphosphate. The mean difference for stain extent index after the six-week trial was 0.04 (+/- 0.08) in the control group, and -0.05 (+/- 0.08) in the test group (p < 0.001). A statistically significant reduction was also reported for intensity and composite indexes. The initial mean for stain extent index in the test group was 0.8 (+/- 0.34), and at six weeks was 0.74 (+/- 0.33; p < 0.001). The initial mean for extent index in the control group was 0.78 (+/- 0.3), and at six weeks was 0.81 (+/- 0.32; p < 0.005). CONCLUSION: This trial showed a reduction in dental stain by a chewing gum containing sodium tripolyphosphate after six weeks.

Whitening effect by stain inhibition from a chewing gum with sodium hexametaphosphate in a controlled twelve-week single-blind trial.

OBJECTIVE: A twelve-week clinical study was conducted to assess the effect of a chewing gum containing sodium hexametaphosphate (4%) on the inhibition of stain formation. METHODOLOGY: Fifty-four subjects were entered and completed all aspects of the study. Twenty-seven of the subjects were smokers, and the other half did not smoke. Subjects were randomly assigned to the test gum or no-gum group. Each participant received a full oral prophylaxis at the beginning of each period of observation. Those chewing the test gum agreed to chew four times a day, for five minutes each time, over twelve weeks. Those assigned to the no-gum group agreed not to chew any gum. After twelve weeks, participants were scored for stain deposits (Lobene Index), received a second oral prophylaxis, and joined the alternate group in this cross-over format. At the end of the twenty-fourth week, all subjects were again scored for stain deposits and the study was completed. In order to enhance stain formation during the entire 24-week study period, all participants received a supply of a chlorhexidine (0.12%) dentifrice without anionic agents to use three times a day. Stain levels were scored by the same examiner for all measurements and recorded on computer. The examiner was blinded to all treatment assignments. RESULTS: There were no reported problems associated with the chewing gum. The Lobene Index mean score for stain extent was 0.54 +/- 0.36) in the test-gum group and 0.81 +/- 0.47) for the no-gum group. The difference between the mean scores was highly significant with paired sample t-test (p < 0.001). Mean stain intensity was 0.57 +/- 0.38) in the test group and 0.95 (+/- 0.72) in the control group, with a statistically significant difference at p < 0.01. CONCLUSION: The results indicated that chewing gum containing sodium hexametaphosphate reduced induced stain formation by 33% compared to a no-gum treatment.

Anticalculus efficacy of a chewing gum with polyphosphates in a twelve-week single-blind trial.

OBJECTIVE: A twelve-week clinical study was conducted to evaluate the effect of a chewing gum containing pyrophosphate (1%) and tripolyphosphate (1%) on controlling supragingival calculus deposits. METHODOLOGY: One-hundred and seventeen subjects enrolled in the study were randomly assigned to either a test gum or no gum group. Each participant received a full oral prophylaxis. Those chewing the test gum agreed to chew four times a day for five minutes each time over twelve weeks. Those assigned to the no gum group agreed not to chew any gum. After twelve weeks, participants were scored for calculus deposits using the modified Volpe-Manhold Calculus Index (VMI), received a second oral prophylaxis and entered the alternate group in this cross-over format. At the end of the twenty-fourth week, all subjects were again scored for calculus deposits and the study was completed. All participants received a supply of a sodium fluoride (0.32%) dentifrice for the study period. Calculus levels were scored by the same examiner for all measurements and recorded on computer. He was blinded to all treatment assignments. RESULTS: One-hundred and eleven participants completed the study. Six participants left the study but none reported problems linked to the pyrophosphates in the chewing gum. The VMI mean score for the test gum group was 2.55 (+/- 2.50) and the mean score for the no gum group was 4.09 (+/- 3.18). The difference between the mean scores was highly significant with paired sample t-test (p < 0.0001). CONCLUSION: The results indicated that a chewing gum containing tripolyphosphate and pyrophosphate reduced calculus formation by 37.6% compared to a no gum treatment.

A six-week study to evaluate the anti-calculus efficacy of a chewing gum containing pyrophosphate and tripolyphosphate.

OBJECTIVE: A six-week, double-blind, cross-over clinical study was conducted to compare the effect of a new chewing gum containing pyrophosphate (1%) and tripolyphosphate (1%), versus a control chewing gum on supragingival calculus deposits. METHODOLOGY: Twenty-eight adult subjects (mean age 34 +/- 8 years) who entered the study were given a full oral prophylaxis and were assigned to chew two pieces of gum, four times a day for five minutes. The gum, either a test chewing gum or placebo chewing gum, was randomly assigned and the subjects were directed to chew their assigned gum for six weeks. All participants also received a 12-week supply of a sodium fluoride (0.32%) dentifrice (Colgate). They were then scored for calculus deposits using the modified Volpe-Manhold Calculus Index (VMI) by the same two examiners. At the end of the first six weeks, the subjects received a second oral prophylaxis and used the alternate chewing gum for a second six-week period of time. The subjects were again scored for calculus deposits and the study was completed. RESULTS: The results demonstrated a mean VMI of 3.65 +/- 2.82 for the test group, and a mean of 4.24 +/- 3.25 for the placebo group. This difference was significant with paired sample t-test (p < 0.001). CONCLUSION: These results indicated that chewing gum containing pyrophosphate and tripolyphosphate reduced supragingival calculus formation by 13.9%, compared to the placebo chewing gum.