Case Studies

The Tough Formula Behind Oral Defense®

Bacteria is the enemy AND the cause of every oral concern.  In a healthy mouth, bacteria are controlled to some degree by salivary constituents and can be kept in that state with the help of oral therapeutics.

ORAL DEFENSE uses a patented double surfactant combination of cetylpyridinium chloride, n-methyl glycene, and enhancing flavoring agents to get an exceptionally bacteriocidal oral therapeutic.  The anions (-) of fluoride and cetylpyridinium chloride attach to tooth and restorative surfaces to provide a long lasting residual of anti-microbial efficacy.

Clinical trials with Colgate Total revealed a superior bleeeding time reduction for gingival disearse with ORAL DEFENSE.  A case study reporting a complete cure for ulcerative necrotizing gingivitis in 10-14 days using ORAL DEFENSE toothpaste alone!


A NEW STUDY found that Recontamination of toothpaste tubes caused by contact from used toothbrushes have been reported in 2 out of 10 cases!  THERE HAS BEEN NO REPORTED TEST CONTAMINATION FROM USING ORAL DEFENSE!



When Colgate Total is introduced to                  Oral Defense Toothpaste kills the
the bacteria, it is not affected.  The                   bacteria it comes in contact with
bacteria even overpowers it!                             and keeps surrounding bacteria at
a distance!


Featured Articles and Studies

A Preliminary Study:

Sodium Lauryl Sulfate and Recurrent Aphthous Ulcers (RAU)
Bente Brokstad Herlofson and Pâl Barkvoil, Department of Oral Surgery and Oral Medicine, Dental Faculty, University of Oslo, Oslo, Norway

Herlofson BB, Barkvoil P. Sodium lauryl sulfate and recurrent aphthous ulcers. A preliminary study. Acta Odontol Scand 1994:52:257-259. Oslo. ISSN 0001-6357.

Sodium lauryl sulfate (SLS), a synthetic detergent commonly used in dentifrices, is an effective denaturant. The aim of the present study was to investigate the effect of SLS in patients with recurrent aphthous ulcers (RAU). Ten patients with multiple minor RAU participated in the study. The mean incidence of RAU was 17.8 during a 3-month period before the study. The patients used a dentifrice containing 1.2% SLS for a test period of 3 months followed by a dentifrice without SLS for the same time period. The results showed a statistically significant decrease in the number of aphthous ulcers from 14.3 after using the SLS- containing dentifrice to 5.1 ulcers after brushing with the SLS-free dentifrice (p < 0.05). It is suggested that the denaturing effect of SLS on the oral mucin layer, with exposure of the underlying epithelium, induces an increased incidence of RAU. • Dentifrice: oral mucosa: recurrent aphthous ulcers

Bente Brokstad Herlofson, Department of Oral Surgery and Oral Medicine, Dental Faculty, University of Oslo, 1109 Blindern, N-0317 Oslo, Norway

Recurrent aphthous ulcers (RAU) are characterized by the development of painful, recurring solitary or multiple necrotizing ulcerations of the non-keratinized oral mucosa and is of unknown etiology.

Different treatments have been tried, including steroids (1), antibiotics (2), chlorhexidine (3,4), and an enzyme-containing toothpaste (5,6). In the latter case a significant decrease in the frequency of RAU was reported (6) when the patients brushed with the toothpaste containing the enzymes amyloglucosidase and glucose oxidase. In 1983 Donatsky et al. (5) recommended use of toothpaste with the same composition for patients with RAU, even though their study did not demonstrate any convincing reducing effect on RAU after comparing the enzyme toothpaste with a placebo paste without the enzymes. The enzyme-containing toothpaste did not contain sodium lauryl sulfate (SLS), which is present in almost all other types of toothpastes (7). This ingredient was not taken into consideration in the above mentioned studies. Barkvoil & Rolla (8) then reported in 1989 a decreased number of oral ulcers in patients with allergic stomatitis after use of an SLS-free test dentifrice compared with a control with the detergent. The aim of the present study was to examine the effect of SLS-containing toothpaste in patients with multiple minor RAU.

Patients and Methods
In this study, 10 volunteers (8 women, 2 men; mean age, 21.5 years; range, 13-35 years) were included, all presenting with multiple RAU. They were all healthy individuals with no systemic drug consumption and showed healthy gingival conditions. Blood screening was carried out, and no abnormalities in hemoglobin, sedimentation rate, differential leukocyte count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin concentration, protein electrophoresis, total protein, immunoglobulins, vitamin B12, iron, and serum folate were found in any of the test subjects. Before the start of the study, the patients recorded in a diary the number of ulcers occurring in a 3-month period during which the participants used their regular toothpaste…

A Pilot Study:
to Assess Antiplaque/Antigingivitis Efficacy of a Dentifrice

E.S. Chaves, J. Liebman, K. Dunleavy, J. Bowman, V.V. Carnell
Hill Top Research, West Palm Beach, FL and BioGlobe Tech, Inc.
Spokane, WA

This pilot study was conducted to evaluate the effectiveness of a dentifrice to prevent gingivitis and inhibit plaque accumulation for a 21-day period. 66 healthy male and female subjects with a minimum of 20 teeth, non-systemic diseases, oral pathologies or severe periodontitis participated in this double-blind, parallel group, controlled clinical trial. At baseline, subjects were evaluated by a single calibrated examiner for oral soft tissues, Turesky modification of the Plaque Index (PI), Modified Gingival Index (MGI), and Gingival Bleeding Index (BI). Subjects received a prophylaxis and were randomly assigned to an experimental dentifrice, Oral Defense® (OD), Colgate Total™ (CT), or Pepsodent (PD). After 3 weeks of unsupervised brushing, 62 subjects returned and all clinical examinations were repeated. Data were analyzed using ANCOVA and paired t-test based on adjusted means. The PI, MGI and BI all showed significant reductions in mean values from baseline to 21 days (p < 0.05). No statistically significant differences were observed for the whole-mouth average and the average interproximal index scores among treatment effects. Compared to Colgate Total™, the test dentifrice had similar reductions in plaque (CT 33%, OD 31%, PD 30%), gingivitis (CT 55%, OD 51%, PD 55%), and bleeding (CT 60%, OD 62%, PD 38%). It was also noted that OD and CT demonstrated a higher percent reduction in bleeding that PD. Based on the limitations of this study, it was concluded that Oral Defense® was as effective as CT in reducing all evaluated clinical indices from baseline. Future studies should include a larger population with a higher percentage of bleeding sites and a study duration of six months.


Literature Cited

  1. Draize, J.H., G. Woodward, and H.O. Calvery. 1944. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. Journal of Pharmacology and Experimental Therapeutics 82, 377-390
  2. Weil, C.S. and A. Scala. 1971. Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicology and Applied Pharmacology 19, 276-360
  3. Frazier, J.M., S.C. Gad, A.M. Goldberg, J.P. McCulley, and D.R. Meyer. 1987. A critical evaluation of alternative tests. In a Critical Evaluation of Alternatives to Acute Ocular Irritation Testing, ed. A.M. Goldberg, Alternative Methods in Toxicology, vol. 4, pp. 45-75. New York: Mary Ann Liebert.
  4. Pape, W.J.W., and U. Hoppe. 1991. In vitro methods for the assessment of primary local effects of topically applied preparations. Skin Pharmacology 4, 205-212.
  5. Pape, W.J.W., U. Pfannenbecker, and U. Hoppe. 1987. Validation of the red blood cell test system as in vitro assay for the rapid screening of irritation potential of surfactants. Molecular Toxicology 1, 525-536.
  6. Pape, W.J.W., and U. Hoppe. 1990. Standardization of an in vitro red blood cell test for evaluating the acute cytotoxic potential of tensides. Arzneim.-Forsch./Drug Research 40, 409-502.
  7. Findlay, R.D., H.W. Taeusch, R. David-Cu, and F.J. Walther. 1995. Lysis of red blood cells and alveolar epithelial toxicity by therapeutic pulmonary surfactants. Pediatric Research 37, 26-30.
  8. Cornelis, M., C. Dupont, and J. Wepierre. 1991. In vitro cytotoxicity tests on cultured human skin fibroblasts to predict the irritation potential of surfactants. ATLA 19, 324-336.