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Biomedical subjects

S Mankodi

Publications and source records attributed to S Mankodi.

14 recordsLinked to original sources

The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinical study on children in the United States of America.

PURPOSE: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 5-17 yr-old children from the Central and South areas of Florida and from the Lares area of Puerto Rico. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. Two calibrated examiners performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. RESULTS: Two thousand five hundred six (2,506) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 2.29 for the Test Dentifrice group, and 2.47 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 0.69 for the Test Dentifrice group and 0.81 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 1.25 for the Test Dentifrice group, and 1.46 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 14.38% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.

Adolescent↗

Anticalculus effect of two zinc citrate/essential oil-containing dentifrices.

PURPOSE: To assess the feasibility of incorporating zinc citrate, a known anticalculus ingredient, into a dentifrice formulation containing a fixed combination of essential oils, a known antiplaque/antigingivitis agent. MATERIALS AND METHODS: This randomized, parallel, double-blind study evaluated the potential of two essential oil dentifrice formulations containing different levels of zinc citrate (1.0% and 2.0% ZCT) to reduce supragingival calculus formation compared to a marketed control dentifrice, Crest Regular. Following a 3-month pre-test phase, subjects received a dental prophylaxis, were stratified into three balanced groups on the basis of Volpe-Manhold calculus scores and brushed twice daily with their assigned dentifrice for 3 months. RESULTS: One hundred ninety-six evaluable subjects completed all phases of the study. ANCOVA revealed that the 1.0% ZCT and 2.0% ZCT essential oil dentifrice formulations provided significant reductions in calculus formation of 26.4% and 29.0% (P< 0.001), respectively, compared to the control dentifrice, Crest Regular. The magnitude of calculus reductions is similar to those levels obtained by other zinc salt formulations.

Adolescent↗

Essential oils in an antiplaque and antigingivitis dentifrice: a 6-month study.

PURPOSE: To determine if a dentifrice formulated with the fixed combination of essential oils possessed antiplaque and antigingivitis properties. MATERIALS AND METHODS: This study was a blinded, randomized, controlled clinical trial. The 6-month study had clinical examinations at baseline, 3 and 6 months. The examinations consisted of three indices; a plaque index, the Modified Gingival Index and a bleeding index. RESULTS: At 6 months, the essential oil-containing dentifrice group had statistically significantly (P < 0.001) lower whole-mouth and interproximal mean plaque index scores exhibiting mean reductions of 18.3% and 18.1% relative to the vehicle control. At 6 months, the essential oil-containing dentifrice group had statistically significantly (P < 0.001) lower whole-mouth and interproximal mean gingival index scores compared to the vehicle control with reductions of 16.2% and 15.5%, respectively. Finally, for the gingival bleeding index, the essential oil-containing dentifrice group had statistically significantly (P < 0.001) lower whole-mouth and interproximal mean bleeding index scores and reductions of 40.5% and 46.9% at 6 months compared to the vehicle control.

Adolescent↗

Clinical study to compare extrinsic stain formation in subjects using three dentifrice formulations.

The purpose of this study was to compare the degree of extrinsic dental stain formed with the use of three dentifrices: (1) a new dentifrice formulation containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength Toothpaste, Colgate-Palmolive Co.); (2) a commercially available dentifrice containing 5.0% potassium nitrate and 0.243% sodium fluoride in a silica base (Sensodyne Fresh Mint Toothpaste, Block Drug Company, Inc.); and (3) a dentifrice containing 0.243% sodium fluoride in a silica base (Colgate Winterfresh Gel, Colgate-Palmolive Co.). A total of 121 participants were entered into the study and stratified into 3 balanced groups according to baseline mean Lobene Stain Index scores. A thorough dental prophylaxis was completed on each participant after completion of the baseline examination. The three groups were randomly assigned to use one of the three dentifrices. The groups were well balanced with regard to mean baseline stain index scores, gender, and tobacco habits. Participants were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Extrinsic dental stain examinations, which measured dental stain area and dental stain intensity, were conducted at baseline and 4 and 8 weeks. Examinations were conducted by the same dental examiner at each examination. After 4 and 8 weeks' use of the test dentifrices, there was no statistically significant difference regarding extrinsic stain formation with the use of any of the dentifrices. Thus, it can be concluded from this study that the use of a new formulation dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base will not result in a greater formation of extrinsic dental staining than that which is formed by two commercially available dentifrices not known to cause extrinsic dental stain.

Adolescent↗

A six-week clinical efficacy study of a tooth whitening tartar control dentifrice for the removal of extrinsic tooth stain.

The objective of this double-blind clinical study was to investigate the tooth whitening efficacy of a new commercially available calculus-inhibiting dentifrice (Colgate Tartar Control Plus Whitening Fluoride dentifrice) containing tetra-sodium pyrophosphate, sodium tripolyphosphate, and PVM/MA copolymer in a 0.243% sodium fluoride/silica base (test dentifrice), compared to a commercially available, non-tooth whitening dentifrice containing 0.243% sodium fluoride in a silica base (control dentifrice). Following a baseline examination for, extrinsic tooth stain, qualifying adult male and female subjects from the Manchester, United Kingdom area were randomized into two treatment groups which were balanced for gender, age and level of extrinsic tooth stain. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice using a soft-bristled toothbrush. Examinations for extrinsic tooth stain were repeated after six weeks' use of the study dentifrices. Seventy-nine(79) subjects complied with the protocol and completed the entire study. At the six-week examination, subjects assigned to the test dentifrice treatment group exhibited statistically significant reductions of over 40% with respect to both extrinsic tooth stain area and extrinsic tooth stain intensity relative to those subjects assigned to the control dentifrice treatment group.

Adult↗

Evaluation of the effects of brushing on the removal of dental plaque.

The ability of three different toothpaste abrasive systems--sodium bicarbonate, hydrated silica, and dicalcium phosphate--to remove dental plaque has been examined. A total of 34 volunteers participated in an independent, double-blind, crossover clinical investigation that compared the amount and percentage of plaque removed with a single brushing with Arm & Hammer Dental Care (sodium bicarbonate), Crest Regular Toothpaste (hydrated silica), and Colgate Regular Toothpaste (dicalcium phosphate) after 48 hours of limited oral hygiene. All three dentifrices removed from 58% to 68% of plaque, but the percentage removed after brushing with Arm & Hammer Dental Care was significantly greater than with either Crest (p = 0.0001) or Colgate (p = 0.0002) during a controlled, 1-minute toothbrushing. The mean amount of plaque removed with Arm & Hammer Dental Care was also significantly greater than that with Crest or Colgate (p = 0.0002 and p = 0.0004, respectively). These results indicate that the abrasive system in Arm & Hammer Dental Care was the most efficient in removing plaque and improving oral hygiene. In the second half of the study, Arm & Hammer Dental Care was compared with Arm & Hammer Peroxicare and Mentadent toothpaste in 45 subjects. All three dentifrices removed from 57% to 70% of the plaque, with Arm & Hammer Dental Care removing significantly more than Mentadent (p = 0.007).

Adolescent↗

Clinical efficacy of an optimized stannous fluoride dentifrice, Part 2: A 6-month plaque/gingivitis clinical study, northeast USA.

The objective of this 6-month, double-blind clinical study, conducted following the American Dental Association guidelines, was to investigate the efficacy of Colgate Optimized Stannous Fluoride (COSF) dentifrice for the control of supragingival dental plaque and gingivitis. This dentifrice contains 0.454% stannous fluoride, stannous chloride, polyphosphate, and citrate in a silica base. At the 3- and 6-month study examinations, the COSF dentifrice group exhibited statistically significant reductions in both plaque and gingivitis compared to the control dentifrice group. At the 6-month examination, the magnitude of these percent reductions exceeded 20% for all 4 parameters measured. Thus, the results of this study support the conclusion that the COSF dentifrice is efficacious for the control of supragingival plaque and gingivitis.

Adult↗

Clinical efficacy of an optimized stannous fluoride dentifrice, Part 5: A 3-month study of extrinsic tooth staining, northeast USA.

The objective of this 3-month, double-blind clinical study was to investigate the level of tooth staining associated with the use of Colgate Optimized Stannous Fluoride (COSF) dentifrice compared to the tooth staining associated with two commercially available dentifrices. The results of this clinical study support the conclusion that the intensity and extent of extrinsic tooth stain associated with the use of the COSF dentifrice are significantly lower than that associated with Crest Gum Care Toothpaste. Further, this study provided no indication that the use of the COSF dentifrice is associated with a greater level of stain than that associated with the use of Crest Regular Toothpaste, a standard 0.243% sodium fluoride/silica dentifrice.

Adult↗

A six-month clinical study of the effect of a pre-brush rinse on plaque removal and gingivitis.

The effect of a pre-brush rinse (Colgate Plax, Colgate UK) containing 0.03% triclosan (Irgacare MP, Ciba-Geigy Corp.) and 0.125% of a copolymer of methoxyethylene and maleic acid (Gantrez, ISP Corp.) on existing plaque and gingivitis over a 6-month period was compared to a matching placebo pre-brush rinse. The study was a double-blind, parallel design utilising 125 subjects, 117 of whom completed the 6-month period. Subjects rinsed twice daily for 60 seconds with 15 ml of their assigned pre-brush rinse. Immediately after rinsing, subjects brushed their teeth for 30 seconds with a fluoride dentifrice and a soft-bristled toothbrush. After 3 and 6 months, the levels of plaque and gingivitis were significantly lower in the triclosan/copolymer rinse group when compared with the placebo rinse group. The beneficial effects of the active rinse were particularly evident on the surfaces of teeth which are poorly cleaned by mechanical procedures. No side effects, such as staining, were observed or reported. The results indicate that the twice daily use of a pre-brush rinse containing triclosan and copolymer can provide significant adjunctive benefits to mechanical oral hygiene procedures.

Adolescent↗

Development and verification of the proximal/marginal plaque index.

The purpose of this study was to compare the ability of experienced and newly trained investigators to use the published Global Plaque Index and a newly developed Proximal/Marginal Index (PMI) that focuses on disclosed plaque at clearly defined proximal and marginal surfaces. Four independent clinical studies were performed, two with each index, on 11 subjects per study. In each study, examinations were conducted before and after brushing, to determine inter- and intra-examiner comparisons over a range of plaque levels. Inter-examiner reliability estimates for the PMI were at a level below Global Plaque index means. Intra-examiner agreement values were similar for both indices. Both scoring systems are considered sufficiently validated to detect product differences in clinical studies.

Clinical Competence↗

A modified Kapur scale for evaluating denture retention and stability: methodology study.

This study described a modification of a standard method for evaluating the retention and stability of complete denture prostheses. The upper ranges of the Kapur Scale for retention and stability were expanded to improve the sensitivity of this procedure. The standard and modified Kapur scales were also compared with a model using two denture adhesives that have demonstrated varying efficacies when evaluated by more refined laboratory instrumentation. This study verified that the modified Kapur scale was more capable of discriminating the effectiveness between the two denture adhesives, confirming the elevated sensitivity of the modified scale. This improvement of the Kapur scale could be valuable in conducting clinical efficacy trials of denture adhesives when more advanced methodologies present logistic problems.

Adhesives↗

Clinical efficacy of listerine in inhibiting and reducing plaque and experimental gingivitis.

103 adult subjects completed a supervised 2-week double-blind controlled clinical study to determine the effect of using either listerine antiseptic (LA) or its vehicle control (VC), as the only oral hygiene procedure, in inhibiting the development of and in reducing plaque and experimental gingivitis. Following baseline examinations, half-mouth prophylaxes were performed on each subject, who continued normal oral hygiene and returned 4 or 5 days later for a second baseline. Subjects then rinsed, under supervision, either 2 or 4 times daily for 2 weeks with LA or twice daily with VC, but suspended all other oral hygiene measures. Plaque and gingivitis were evaluated at baselines and after 2 weeks. Subjects using LA 2 or 4 times a day as the only oral hygiene procedure for 2 weeks demonstrated highly significant inhibition and reduction of both supragingival plaque and gingival inflammation compared to those using VC.

Adolescent↗

Clinical effect of a triclosan-containing dentifrice on plaque and gingivitis: a six-month study.

A total of 294 adult male and female subjects completed a 6-month, double-blind clinical trial designed to evaluate the effects of a dentifrice which contained 0.3% triclosan in conjunction with 2% of a methoxyethylene/maleic acid copolymer in a 0.243% sodium fluoride/silica base, relative to a control dentifrice, on supragingival plaque accumulation and gingivitis. Plaque and gingivitis were scored after 3 and 6-month use of the assigned dentifrice. At the end of the study, the triclosan group showed an average reduction, relative to the control group, of 12% in plaque accumulation and 20% in gingivitis. Both were statistically significant at p < or = 0.0001. The effect of the triclosan dentifrice was most pronounced on the more severe manifestations of plaque and gingivitis. The improvement in the gingival parameters at 6-months relative to the control dentifrice was statistically significant at p < or = 0.0001. It was concluded that the twice-daily use of the triclosan-containing dentifrice resulted in significant reduction in supragingival plaque formation and a significant improvement in gingival health without the presence of any extrinsic staining or objectionable taste.

Adolescent↗