Clinical Studies

Clinical Evaluation of Purebrush: Effect on Toothbrush Contamination

Purpose:
     To evaluate the capacity of Purebrush to reduce or eliminate contamination of a toothbrush following normal daily use.

Subjects:
     Eight healthy subjects were randomly selected to participate in the study. Both sexes were represented in the study and subjects ranged in age from 25 - 65 years of age. Each subject selected was assigned a test number for purposes of identification of brushes used throughout the study.

Toothbrush and Dentifrice:
     The same type of commercially available toothbrush was supplied to each of the subjects at the outset of the study. The toothbrushes were the standard 4 row type with rounded nylon bristles. In addition, in order to standardize the study for comparative purposes, each of the subjects was provided with a fluoride containing dentifrice to be used throughout the study. The subjects were then be randomized into two groups of 4 per group, labeled as Group A and Group B.

Procedure:
     Three separate clinical protocols were employed to evaluate the capacity of the Purebrush appliance to reduce or eliminate microbial contamination of toothbrushes. These protocols are detailed below as Protocol I, Protocol II and Protocol III.

Protocol I:
     Subjects were instructed to brush their teeth in accustomed manner. Each brush was assigned an identifying number four brushes in each group. In the morning after brushing, the brushes were collected and one group of brushes received u.v. irradiation in the Purebrush appliance for 1 hour, the second group was air dried. Subjects again brushed their teeth in the afternoon and the treatment for each group was repeated. This daily cycle of toothbrushing followed by treatment of the brushes was carried out over a 14 day period. On the 14th day after the morning brushing, each group of brushes received its appropriate treatment, (irradiation or air drying). Following the 1 hour treatment period, the brushes were examined for the number of organisms present. The following week, the groups were crossed over. The brushes from the subjects that were irradiated in the previous 14 day test were air dried and the brushes from the individuals whose brushes were air dried were irradiated. This permitted direct comparison between the number of organisms recovered following air drying. The 14 day period was selected to allow the build up of organisms, if any, on the toothbrush following repeated use.

Protocol II:
     The subjects were randomized into two groups, Group A and Group B. There were 4 subjects in each group. In the morning, each individual was issued the same type of commercially available 4 row nylon bristle brush and issued a commercially available fluoride containing dentrifice. The test subjects did not brush their teeth since the night before. The subjects were instructed to immediately brush their teeth in the manner they are normally accustomed to using. After tooth brushing, the brushes were collected and separated into the assigned groups. One group received u.v. irradiation in the Purebrush appliance and second group was air dried. At the end of this treatment period, the number of organisms on each brush were determined. The next day, the subjects repeated the procedure. The brushes were collected following the toothbrushing and separated into the assigned groups. However, the group that on the previous day had brushes that were irradiated in the Purebrush appliance, were air dried and the brushes from the subjects whose brushes were air dried were irradiated. At the end of these treatment periods, the number of organisms present on each brush was determined. This cross over design allowed direct comparisons between the irradiated and air dried groups without the build up of organisms allowed Protocol I. These data from this study permitted comparisons to be made following normal use of a toothbrush and would demonstrate the initial benefit to be gained from u.v. irradiation in the Purebrush appliance as compared with air drying.

Protocol III:
     The subjects were issued a commercially available 4 row nylon bristle brush and also a commercially available fluoride containing dentrifice. They were requested to brush their teeth in the normal manner. After toothbrushing the brushes were collected and sorted into the assigned groups. One group was placed in the Purebrush appliance and received u.v. irradiation for 1 hour, the second group was air dried for 1 hour. At the end of this period, the brushes were allowed to continue to air dry for another 7-8 hour period. The subjects brushed again and the treatment (U.V. irradiation or air dry) was repeated with an overnight period of air drying. The subject brushed the following morning and the brushed were again treated (U.V. or air drying) and then allowed to air dry for six additional hours. At the end of this drying period, the number of organisms present on each the brushes was determined. The procedure was repeated with a cross-over in treatment of brushes, i.e. the brushes from the subjects that had been irradiated and air dried previously were now air dried only and those brushes which were air dried only were irradiated in the Purebrush appliance for 1 hour followed by a period of air drying for 6 hours. After this drying period, each of the brushes were again examined for the presence of the number of organisms on each brush. This clinical design would provide information as to the advantage of the Purebrush appliance and reducing the number of organisms on a brush between usage. Under normal circumstance, an individual would brush his teeth, place his brush in a Purebrush appliance and the brush would automatically receive a 1 hour u.v. irradiation. However, the brush would continue to air dry over the next 7 or 8 hours or longer before the brush is then use again. What this design provides is the information as to the efficacy of Purebrush u.v. irradiation place air dry as oppose to air drying alone.
     In each of the various clinical designs, a different kind of information was generated. We have tried to anticipate the kind of data that would be generated and the interpretation to be placed on it.

Results

     The results of this study are summarized in the accompanying tables for Protocols I, II, & III. It is evident that exposure of toothbrushes to U.V. radiation in the Purebrush Appliance provides a significant advantage over air drying as determined by the recovery of organisms following each kind of treatment.

Protocol I
Organisms recovered from toothbrushes when either air-dried or exposed to U.V. radiation in Purebrush Appliance.

Number of Organisms Received

Protocol II
Organisms recovered from toothbrushes when either air-dried or exposed to U.V. radiation in Purebrush Appliance.

Number of Organisms Received

Protocol III
Organisms recovered from toothbrushes when either air-dried or exposed to U.V. radiation in Purebrush Appliance.

Number of Organisms Received

* Left University prior to start of this Protocol.

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