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1.
J Clin Dent ; 18(1): 1-6, 2007.
Article in English | MEDLINE | ID: mdl-17410948

ABSTRACT

OBJECTIVE: This single blind, crossover design, clinical trial provided a comparative assessment of the oral cleaning of two dental devices as demonstrated through the removal of dental plaque when used according to marketed product-use directions. METHODOLOGY: Twenty-six subjects, both male and female between the ages of 19 and 64 years, completed this two-cell crossover study. Subjects were assessed for whole mouth plaque levels, both before and after use of each of the randomly assigned floss devices, by assessing disclosed plaque using the Modified Turesky Plaque Index. The two floss devices were a Mint Floss Pick and a standard rolled floss. Subjects abstained from brushing the night before appearing in the clinic, and based upon meeting the minimum plaque criteria of 1.5 at the first phase of the crossover, used one of the two floss devices according to the directions for use found on the product packaging. Both pre- and post-device use plaque levels were recorded with calculations made of both the actual difference in plaque level, as well as the percent plaque removed. Data were subjected to an analysis of covariance (ANCOVA), and employed a model consistent with crossover design. RESULTS: Overall results from both phases of the crossover showed the Mint Floss Pick product removed 19.4% of the plaque. The standard rolled floss product removed 15% of the plaque. Both products removed statistically significant plaque when assessed versus pre-treatment levels. Although the ANCOVA identified a statistically significant difference between treatments favoring the Floss Pick product, further statistical examination revealed a significant sequence effect, which led to a conservative product comparison of equivalence. This analysis confirmed that the Floss Pick product was "at least as good as" the standard floss product for plaque removal. Additional analyses of various sites in the mouth, i.e., interproximal, anterior, posterior, etc., also confirmed similarity of performance for both products in this test. CONCLUSION: A two-way crossover assessment of the cleaning capability of a Mint Floss Pick product compared to a standard rolled floss product was performed through assessment of the removal of dental plaque. Results of this clinical investigation support the Floss Pick product to be "at least as good as" standard rolled floss in cleaning capability when both products were used according to their product-use directions.


Subject(s)
Dental Devices, Home Care , Dental Plaque/therapy , Oral Hygiene/instrumentation , Adult , Epidemiologic Methods , Female , Humans , Male , Middle Aged
2.
J Clin Periodontol ; 31(10): 878-84, 2004 Oct.
Article in English | MEDLINE | ID: mdl-15367192

ABSTRACT

OBJECTIVES: The objective of this study was to compare the antiplaque and antigingivitis effectiveness and the side-effect profiles of an essential oil-containing mouthrinse and a chlorhexidine-containing mouthrinse. MATERIAL AND METHODS: One hundred and eight qualifying subjects, aged 20-57 years, were randomized into three groups: essential oil mouthrinse (ListerineAntiseptic); 0.12% chlorhexidine mouthrinse (Peridex); or 5% hydroalcohol negative control. At baseline, subjects received a complete oral soft tissue examination and scoring of the Loe-Silness gingival index (GI), Quigley-Hein plaque index (PI), Volpe-Manhold calculus index (CI), and Lobene extrinsic tooth stain index (SI). Following a complete dental prophylaxis, subjects started rinsing twice daily with their respective mouthrinse as an adjunct to their usual mechanical oral hygiene procedures. One of the rinses on each weekday was supervised. Subjects were reexamined at 3 and 6 months. The treatment groups were compared with respect to baseline demographic and clinical variables. The primary efficacy variables were GI and PI. Intergroup differences for all clinical variables were tested at 3 and 6 months using appropriate statistical procedures. RESULTS: All of the 108 randomized subjects were evaluable at 3 months, and 107 subjects were evaluable at 6 months. There were no statistically significant differences among the three groups at baseline, with the exception that the control group PI was significantly lower than that of the essential oil group (p<0.05) and the chlorhexidine group (p<0.001), and the essential oil mouthrinse group had a significantly greater number of subjects than the control group with body region SI scores > or =1.0 (p=0.021). At 6 months, the essential oil and chlorhexidine mouthrinses produced statistically significant (p<0.001) GI reductions of 14.0% and 18.2%, respectively, and statistically significant (p<0.001) PI reductions of 18.8% and 21.6%, respectively, compared with the control and were not statistically significantly different from each other with respect to plaque and gingivitis reduction. The chlorhexidine mouthrinse group had significantly more calculus and extrinsic tooth stain than either the essential oil mouthrinse group or the control group. CONCLUSION: This 6-month controlled clinical study demonstrated that the essential oil mouthrinse and the chlorhexidine mouthrinse had comparable antiplaque and antigingivitis activity. Insofar as side effects associated with the chlorhexidine mouthrinse may limit patient compliance, it is suggested that each product can have a distinct role in the management of patients with periodontal diseases.


Subject(s)
Chlorhexidine/therapeutic use , Dental Plaque/drug therapy , Gingivitis/drug therapy , Mouthwashes/therapeutic use , Oils, Volatile/therapeutic use , Adult , Chlorhexidine/adverse effects , Dental Calculus/chemically induced , Dental Plaque Index , Epidemiologic Methods , Female , Humans , Male , Middle Aged , Mouthwashes/adverse effects , Oils, Volatile/adverse effects , Periodontal Index , Tooth Discoloration/chemically induced
3.
J Am Dent Assoc ; 134(3): 359-65, 2003 Mar.
Article in English | MEDLINE | ID: mdl-12699051

ABSTRACT

BACKGROUND: The use of dental floss has long been considered to be effective in controlling interproximal plaque and gingivitis. The authors compared this method with that of use of a mouthrinse. METHODS: Subjects with mild-to-moderate gingivitis enrolled in a long-term, six-month study. They received a dental prophylaxis and were randomized into one of the three following treatment groups: brushing and rinsing with an essential oil-containing mouthrinse (the BEO group), brushing and flossing (the BF group) and brushing and rinsing with a control rinse (the B group). RESULTS: A total of 326 subjects were evaluated. The BEO and BF had significantly lower (P < .001) mean interproximal Modified Gingival Index, or MGI, scores than did the B group at six months. The BEO group had lower mean interproximal Plaque Index, or PI, scores than the other two groups at both three and six months. The BF group's mean PI score was significantly lower than the B group's mean score at six months only. The magnitude of reductions for the BEO and the BF groups (vs. the B group) in MGI were 11.1 percent and 4.3 percent and for PI were 20.0 percent and 3.4 percent, respectively. CONCLUSIONS: In conjunction with professional care (prophylaxis) and toothbrushing over six months, rinsing twice daily with an essential oil-containing mouthrinse was at least as good as flossing daily in reducing interproximal plaque and gingivitis. Clinical Implications. When weighing recommendations for oral hygiene home care, clinicians should consider that an essential oil-containing mouthrinse may be a useful adjunct in patients with gingival inflammation.


Subject(s)
Anti-Infective Agents, Local/therapeutic use , Gingivitis/prevention & control , Mouthwashes/therapeutic use , Oils, Volatile/therapeutic use , Salicylates/therapeutic use , Terpenes/therapeutic use , Adolescent , Adult , Aged , Dental Devices, Home Care , Dental Plaque Index , Drug Combinations , Female , Humans , Male , Middle Aged , Periodontal Index , Treatment Outcome
4.
Am J Dent ; 14 Spec No: 13A-17A, 2001 May.
Article in English | MEDLINE | ID: mdl-11481926

ABSTRACT

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.


Subject(s)
Calcium Phosphates/pharmacology , Cariostatic Agents/pharmacology , Dental Caries/prevention & control , Sodium Fluoride/pharmacology , Toothpastes/therapeutic use , Adolescent , Analysis of Variance , Calcium Phosphates/administration & dosage , Cariostatic Agents/administration & dosage , Child , Child, Preschool , DMF Index , Dental Caries/epidemiology , Double-Blind Method , Drug Delivery Systems , Female , Florida/epidemiology , Humans , Male , Puerto Rico/epidemiology , Sodium Fluoride/administration & dosage , Toothpastes/pharmacology , Treatment Outcome
5.
Compend Contin Educ Dent ; 22(7A): 29-32, 2001 Jul.
Article in English | MEDLINE | ID: mdl-11913307

ABSTRACT

A 14-week, double-blind, randomized clinical trial was conducted with 126 healthy volunteers to compare the efficacy of twice-daily use of 3 baking soda-containing chewing gums in removing natural tooth stain when used in conjunction with a program of regular oral hygiene. All 3 chewing gums significantly reduced extrinsic stain (P < .0001) and improved the whitened appearance of teeth (P < .0001) at both the 2-week interim and the final 4-week evaluations. ARM & HAMMER DENTAL CARE The Baking Soda Gum (AHDC) reduced dental stain by 70.8%, compared to reductions of 71.9% and 65.3%, after use of 2 experimental gum formulations. Whitened appearance improved by 1.73 shade tabs using AHDC gum, and up to 2.49 shade tabs with the experimental formulations. These results suggest that the use of baking soda-containing gum after meals, in conjunction with good oral hygiene, can improve both extrinsic dental staining and the whitened appearance of teeth.


Subject(s)
Chewing Gum , Sodium Bicarbonate/therapeutic use , Tooth Discoloration/therapy , Adult , Aged , Analysis of Variance , Double-Blind Method , Female , Humans , Male , Middle Aged , Toothbrushing , Treatment Outcome
6.
Compend Contin Educ Dent Suppl ; (27): 23-7; quiz 28, 2000.
Article in English | MEDLINE | ID: mdl-11908357

ABSTRACT

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.


Subject(s)
Dentifrices/adverse effects , Tooth Discoloration/chemically induced , Adolescent , Adult , Aged , Air , Analysis of Variance , Complex Mixtures , Dentin Sensitivity/drug therapy , Double-Blind Method , Drug Combinations , Female , Fluorides/adverse effects , Humans , Male , Middle Aged , Nitrates/adverse effects , Phosphates/adverse effects , Potassium Compounds/adverse effects , Silicon Dioxide , Sodium Fluoride , Tin Fluorides/adverse effects , Touch
7.
Am J Dent ; 13(Spec No): 11C-13C, 2000 Sep.
Article in English | MEDLINE | ID: mdl-11763907

ABSTRACT

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.


Subject(s)
Anti-Infective Agents, Local/therapeutic use , Citric Acid/therapeutic use , Dental Calculus/prevention & control , Dentifrices/therapeutic use , Oils, Volatile/therapeutic use , Zinc Compounds/therapeutic use , Adolescent , Adult , Aged , Analysis of Variance , Anti-Infective Agents, Local/administration & dosage , Chemistry, Pharmaceutical , Citric Acid/administration & dosage , Dental Plaque/prevention & control , Double-Blind Method , Feasibility Studies , Female , Follow-Up Studies , Gingivitis/prevention & control , Humans , Male , Middle Aged , Oils, Volatile/administration & dosage , Silicic Acid , Silicon Dioxide/therapeutic use , Sodium Fluoride/therapeutic use , Statistics as Topic , Toothbrushing , Toothpastes , Zinc Compounds/administration & dosage
8.
Am J Dent ; 13(Spec No): 5C-10C, 2000 Sep.
Article in English | MEDLINE | ID: mdl-11763912

ABSTRACT

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.


Subject(s)
Anti-Infective Agents, Local/therapeutic use , Dental Plaque/prevention & control , Dentifrices/therapeutic use , Gingivitis/prevention & control , Oils, Volatile/therapeutic use , Adolescent , Adult , Analysis of Variance , Anti-Infective Agents, Local/administration & dosage , Dental Plaque Index , Double-Blind Method , Female , Follow-Up Studies , Gingival Hemorrhage/prevention & control , Humans , Male , Middle Aged , Observer Variation , Oils, Volatile/administration & dosage , Periodontal Index , Pharmaceutical Vehicles , Reproducibility of Results , Sample Size , Statistics as Topic , Toothbrushing
9.
J Clin Dent ; 10(3 Spec No): 99-102, 1999.
Article in English | MEDLINE | ID: mdl-10825854

ABSTRACT

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.


Subject(s)
Dentifrices/therapeutic use , Tooth Bleaching/methods , Tooth Discoloration/therapy , Adult , Aged , Complex Mixtures , Dental Calculus/therapy , Double-Blind Method , Female , Humans , Male , Middle Aged , Polyphosphates , Silicic Acid , Silicon Dioxide/therapeutic use , Sodium Fluoride/therapeutic use , Toothpastes , Treatment Outcome
10.
J Clin Dent ; 9(3): 57-60, 1998.
Article in English | MEDLINE | ID: mdl-10518862

ABSTRACT

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).


Subject(s)
Dental Plaque/prevention & control , Dentifrices/therapeutic use , Sodium Bicarbonate/therapeutic use , Adolescent , Adult , Aged , Cross-Over Studies , Dental Plaque Index , Dentifrices/chemistry , Double-Blind Method , Drug Evaluation , Female , Humans , Hydrogen Peroxide , Male , Middle Aged , Silicic Acid , Silicon Dioxide/therapeutic use , Sodium Fluoride/therapeutic use , Toothbrushing , Toothpastes
11.
Compend Contin Educ Dent ; 18 Spec No: 10-5, 1997.
Article in English | MEDLINE | ID: mdl-12206029

ABSTRACT

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.


Subject(s)
Dental Plaque/prevention & control , Dentifrices/therapeutic use , Gingivitis/prevention & control , Tin Fluorides/therapeutic use , Adult , Analysis of Variance , Chemistry, Pharmaceutical , Citrates/chemistry , Dental Plaque Index , Dentifrices/chemistry , Double-Blind Method , Female , Follow-Up Studies , Humans , Male , Middle Aged , New Jersey , Periodontal Index , Silicon Dioxide/chemistry , Sodium Fluoride/administration & dosage , Sodium Fluoride/therapeutic use , Tin Compounds/chemistry , Tin Fluorides/administration & dosage , Tin Fluorides/chemistry , Tin Polyphosphates/chemistry
12.
Compend Contin Educ Dent ; 18 Spec No: 24-7, 1997.
Article in English | MEDLINE | ID: mdl-12206033

ABSTRACT

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.


Subject(s)
Dentifrices/therapeutic use , Tin Fluorides/therapeutic use , Tooth Discoloration/chemically induced , Adult , Aged , Analysis of Variance , Beverages , Chemistry, Pharmaceutical , Citrates/chemistry , Dentifrices/chemistry , Double-Blind Method , Female , Follow-Up Studies , Food , Gluconates/chemistry , Humans , Male , Middle Aged , New Jersey , Silicon Dioxide/chemistry , Smoking , Sodium Fluoride/administration & dosage , Sodium Fluoride/chemistry , Sodium Fluoride/therapeutic use , Statistics as Topic , Tin Compounds/chemistry , Tin Fluorides/administration & dosage , Tin Fluorides/chemistry , Tin Polyphosphates/chemistry , Tooth Discoloration/classification
13.
J Pharm Sci ; 85(8): 842-7, 1996 Aug.
Article in English | MEDLINE | ID: mdl-8863274

ABSTRACT

Two clinical studies were conducted to determine the relative amounts of ketorolac detectable locally in the gingival crevicular fluid (GCF) and systemically in plasma after oral, topical drug administration. The rinse study compared topical administration of three concentrations of ketorolac tromethamine (0.1%, 0.5%, and 0.01%) in oral rinse formulations administered topically and a perorally administered capsule (10 mg), and the dentifrice study compared two concentrations of ketorolac in dentifrice formulations (0.15% and 1.0%) with a 0.1% oral rinse, all treatments administered topically. The dose-corrected systemic availability of the three oral rinses evaluated in the rinse study relative to the peroral capsule was about 15%. However, the ratios of the observed maximum GCF ketorolac concentration to maximum plasma ketorolac concentration ranged from 22 to 49, compared to less than 1 for the peroral ketorolac capsule. Using this ratio as an estimate of the ability of a treatment to target the drug to the gingival tissue, these data indicate that the ketorolac oral rinses achieved greater delivery of drug to the gingival tissue (presumed site of action for periodontitis) with a lower systemic drug load than peroral administration of a ketorolac capsule. The dose-corrected relative systemic bioavailabilities for the dentifrice treatments with respect to the 0.1% rinse in the dentifrice study were 59.2% and 86.4% for the 1.0% and 0.15% dentifrices, respectively, indicating that significantly less ketorolac was systemically available from the two dentifrices relative to the oral rinse. The relative bioavailabilities of ketorolac in the GCF after dosing with the dentifrice formulations with respect to the rinse were 89.1% for the 1.0% dentifrice and 19.7% for the 0.15% dentifrice. Thus, the 1.0% dentifrice appears to provide statistically equivalent levels of ketorolac to the gingival tissue as the 0.1% oral rinse with significantly less systemic exposure. The T1/2 of ketorolac in the GCF was about 0.5 h for all three treatments, which is significantly less than the plasma half-life of about 5.3 h. These data suggest that GCF levels of ketorolac should remain above the IC50 for PGE2-stimulated IL-1 bone resorption for about 7 h following treatment, assuming continuation of the first-order elimination observed over the first two postdosing hours. We conclude that oral rinses and dentifrices are effective and preferred vehicles for administration of ketorolac for use in treatment of periodontitis.


Subject(s)
Dentifrices , Gingival Crevicular Fluid/chemistry , Mouthwashes , Tolmetin/analogs & derivatives , Administration, Topical , Adult , Aged , Double-Blind Method , Half-Life , Humans , Ketorolac , Middle Aged , Placebos , Tolmetin/blood , Tolmetin/pharmacokinetics , Tolmetin/therapeutic use
14.
Br Dent J ; 175(9): 322-6, 1993 Nov 06.
Article in English | MEDLINE | ID: mdl-8251249

ABSTRACT

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.


Subject(s)
Benzoates/therapeutic use , Dental Plaque/drug therapy , Gingivitis/drug therapy , Mouthwashes/therapeutic use , Sodium Dodecyl Sulfate/therapeutic use , Triclosan/therapeutic use , Adolescent , Adult , Aged , Dental Plaque Index , Double-Blind Method , Female , Humans , Male , Maleates/therapeutic use , Middle Aged , Periodontal Index , Polyvinyls/therapeutic use
15.
J Clin Periodontol ; 20(4): 279-81, 1993 Apr.
Article in English | MEDLINE | ID: mdl-8473539

ABSTRACT

This double-blind, controlled clinical study compared the effectiveness of 30- and 60-s listerine rinses in both inhibiting the development of, and reducing existing, supragingival plaque and gingivitis, using an experimental gingivitis model. 94 subjects completed this study. For each subject, a modified gingival index, modified Quigley-Hein plaque index and Eastman interdental bleeding index were recorded at baseline and at 2 weeks. Following the baseline examinations, subjects received half-mouth prophylaxes, and began 2 x daily supervised rinsing either with listerine for 30 or 60 s or with a control mouthrinse for 30 s as their sole oral hygiene measure. Statistical analysis (ANCOVA) showed that both the 30- and 60-s listerine rinses were significantly (p < 0.01) more effective than the control in inhibiting and reducing plaque, gingivitis and gingival bleeding. Although 60-s rinses with listerine were significantly more effective (p < 0.01) than 30-s rinses in controlling plaque, the 2 rinse durations were similarly effective in controlling interdental bleeding and gingivitis. This study confirms the recommendation of 2x daily rinsing with listerine for 30 s as an effective regimen for gingivitis control.


Subject(s)
Dental Plaque/drug therapy , Gingivitis/drug therapy , Mouthwashes/therapeutic use , Salicylates/therapeutic use , Terpenes/therapeutic use , Adolescent , Adult , Analysis of Variance , Dental Plaque Index , Double-Blind Method , Drug Combinations , Female , Humans , Male , Middle Aged , Mouthwashes/administration & dosage , Oral Hygiene/methods , Periodontal Index , Salicylates/administration & dosage , Terpenes/administration & dosage , Time Factors
16.
J Clin Dent ; 4(1): 14-20, 1993.
Article in English | MEDLINE | ID: mdl-8357507

ABSTRACT

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.


Subject(s)
Dental Plaque Index , Dental Plaque/diagnosis , Clinical Competence , Dentists , Humans , Observer Variation , Reproducibility of Results
17.
Clin Prev Dent ; 14(6): 4-10, 1992.
Article in English | MEDLINE | ID: mdl-1298577

ABSTRACT

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.


Subject(s)
Dental Plaque/prevention & control , Dentifrices/therapeutic use , Gingivitis/drug therapy , Maleates/therapeutic use , Polyvinyls/therapeutic use , Triclosan/therapeutic use , Adolescent , Adult , Analysis of Variance , Dental Plaque Index , Double-Blind Method , Female , Humans , Longitudinal Studies , Male , Middle Aged , Periodontal Index
18.
Am J Dent ; 5(2): 88-90, 1992 Apr.
Article in English | MEDLINE | ID: mdl-1524753

ABSTRACT

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.


Subject(s)
Adhesives/standards , Denture Retention/standards , Analysis of Variance , Carboxymethylcellulose Sodium , Double-Blind Method , Female , Humans , Karaya Gum , Male , Maleates , Polyethylenes , Polyvinyls
20.
J Periodontol ; 60(3): 159-62, 1989 Mar.
Article in English | MEDLINE | ID: mdl-2746448

ABSTRACT

Using an experimental gingivitis model, 99 subjects completed a 3-week study to determine the correlations between a visual index of gingivitis, the Modified Gingival Index (MGI), and the Gingival Index (GI), the Interdental Bleeding Index (IBI), and the Papillary Bleeding Index (PBI). Following a baseline examination consisting of the MGI and either the GI, IBI, or PBI, each subject received a full mouth scaling and rubber cup polishing to render the teeth plaque and calculus free. Subjects then rinsed twice daily for 30 seconds with 20 ml of either an active antimicrobial or control mouthrinse for 3 weeks while abstaining from all other oral hygiene. The MGI correlated significantly with the GI, IBI, and PBI, both at baseline and at 3 weeks for all subjects.


Subject(s)
Gingivitis/diagnosis , Periodontal Index , Adolescent , Adult , Double-Blind Method , Female , Gingival Hemorrhage/diagnosis , Gingival Pocket/diagnosis , Humans , Male , Middle Aged , Mouthwashes/therapeutic use , Random Allocation
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