Independent Laboratory Study
Determining the Effectiveness of an Oral Homecare Regimen in Controlling Malodor
by Hilltop Reasearch Inc., 900 Osceola Drive, West Palm Beach, Florida 33409
The study was conducted using a randomized, evaluator-blind, no treatment control test design with two treatment groups. A total of 60 subjects participated in this study. Thirty-six of these subjects were randomized to the ProFresh Home Care Maintenance Program and twenty-four remained untreated controls. The objective of the study was to evaluate the effectiveness of the ProFresh regimen in controlling human intrinsic oral malodor using hedonic methodology. Candidates reported to the clinical facility, executed an informed consent and were screened by the examining dentist to rule out oral pathology.
A panel of five trained and experienced odor judges were utilized for each of the testing sessions. Subjects were then assessed for oral malodor on two consecutive mornings prior to initialization of treatment and once after using the regimen twice daily for seven days. A direct nose-to-mouth organoleptic technique was employed using glass tubes.
A mean baseline organoleptic odor score of > 7 was used as the criteria for halitosis. Qualified subjects were given the treatment and asked to use it twice per day for seven days. On the morning of Day 8, 12-15 hours after last use of the regimen, subjects returned to the test facility for a post-treatment breath odor assessment. Again a mean odor score was calculated and compared to the baseline score.
Results of this study showed that the ProFresh Homecare Regimen significantly reduced oral malodor whereas the untreated group did not show any effect.
Three subjects on the ProFresh regimen did not return on Day 8 for the post-treatment evaluation.
No adverse events were reported during the study.
The results of the analysis of covariance indicated that the ProFresh regimen was significantly (p=0.0001) more effective in the control of oral malodor at 12 hours after the 14 treatments (7 days of twice a day use) than Untreated. The mean odor scores are summarized below:
Thirty-six subjects were randomized to receive the ProFresh Homecare Maintenance Program kit and 24 remained untreated. A mean organoleptic odor score of > 7 was used as the criteria for halitosis. After using the ProFresh Homecare regimen twice daily for seven days, twenty-nine out of 33 subjects (88%) showed a mean odor score of 7 compared to only 3 of 24 subjects (13%) on the untreated group.
The statistical analysis of the data showed that the ProFresh Homecare Maintenance Program significantly reduced oral malodor while the untreated control group did not show this effect.
Safety of ProFresh Oral Rinse
Chlorine dioxide (ClO2) is a water-soluble gas that is a highly effective yet non-toxic malodor counteractant and germicide. It is listed as an ingredient in many mouthrinses, although only one product [ProFresh] actually contains it, at a safe level of acidity. This uniqueness is confirmed by ProFresh’s patent on the use of ClO2 for neutralizing oral malodor (U.S. Patent No. 5,738,840).
ProFresh solution contains about 0.0040% [which is 40 parts per million (“ppm”)] of ClO2, a deceptively low level for what it can accomplish. For example, many municipal water supplies use ClO2 as a disinfectant, at levels less than 1 ppm, in place of higher levels of chlorine, a well-known mutagen. The ClO2 in ProFresh is prepared by the user, who adds to the unactivated solution a small amount of oxidizer and pH adjuster from separate pouches. The unactivated solution contains an excess of chlorite (as sodium chlorite). The oxidizer is fully destroyed in the process, and is replaced by ClO2. The activated solution still contains additional chlorite reservoir, from which further ClO2 is produced to replace the small amounts that may be lost from daily usage.
When ClO2 is used in drinking water disinfection, it slowly degrades to chlorite, chloride, and chlorate. The EPA, in establishing the safety of drinking water with ClO2 and these degradation products, assumes that an average person will drink up to 2 liters (more than 2 quarts) of this water daily. To determine the safety of continuous daily drinking of ClO2-treated water, the EPA makes use of so-called proposed Reference doses (RfDs) based on a series of toxicology studies, in which the animal received much higher levels of the various chloro-species mentioned above. RfDs are conservative figures which can be used to determine how much of different chemicals may be safely ingested on a daily basis. The RfDs are expressed in amount (mgs) of material per unit of body weight (kgs) per day. This allows them to account for the different sizes of the various test animals used in the studies. And, as more studies are completed, these RfDs are updated.
We have compared the estimated intake of ClO2 and chlorite that ProFresh users may ingest, based on their swallowing as much as 10% of the half-ounce (15 ml) rinse dose, twice a day. These estimated daily doses are 0.0024 and 0.1 mg/kg/day, for ClO2 and chlorite respectively. In contrast, the most current RfD’s for ClO2 and chlorite, respectively, are 0.01 mg/kg/day and 0.1 mg/kg/day. It can therefore be concluded that, when the product is used as directed:
The daily doses for both compounds, chlorine dioxide and sodium chlorite, are at or below the RfD. Given the conservative nature of the risk assessment approach, the lack of effects reported in exposed humans, and the reduction of these compounds during rinsing and swallowing, the manufacturer’s recommended use of the product ProFresh by adults, including incidental ingestion, does not represent a risk to human health.
Robert D. Kross
P.O. Box 374
Bellmore, NY 11710
ProFresh Daily Regimen Reduces Dental Plaque
In addition to being the most effective breath control product available, the ProFresh System significantly reduces the amount of free floating bacteria in the mouth and consequently the amount of dental plaque that builds up around the teeth and gums. Dental plaque causes tooth decay, periodontal disease and has been linked to heart disease.
The following are excerpts from two scientific studies conducted by respected sources and previously published in medical and dental journals. These studies were conducted to determine the effectiveness of tongue cleaning in reducing dental plaque formation. Results were clear that tongue cleaning significantly reduces oral debris and, as a result, slows plaque formation and accumulation.
A study1 by: E.L. Gilmore, A. Gross and R. Whitley stated:
“Tongue and plaque samples from seven of twenty-two caries-susceptible persons produced a thick, gelatinous plaque on wires. Neither tongue nor plaque samples from the remaining fifteen subjects produced a similar type of plaque in vitro. The formation of this characteristic artificial plaque was attributable to a streptococcus salivarius variant. The tongue appeared to be a major source of these variants. Following 2 weeks of tongue brushing, these organisms could no longer be isolated from either tongue or “newly” formed plaque. These results show that numbers and types of plaque organisms are altered by a regimen of daily brushing!”
Another study2 conducted by Steven E. Jacobson, James J. Crawford, and Walter R. McFall, Jr. was performed on 30 adults to determine if oral physiotherapy of the tongue and palate reduced oral debris enough to effect a reduction in initial dental plaque formation, total plaque accumulation on the teeth and gingival inflammation. The following conclusions were drawn:
“The tongue harbors and sheds many microorganisms each day. Investigators of the source of salivary microorganisms conclude that a large proportion of salivary microorganisms emanate from the tonge, and that in general, microorganisms of the tongue influence the flora of the entire oral cavity. There is also a continuous shedding of cells of the surface layer of epithelium from the tongue and palate. The availability of oral debris from these sites could contribute to plaque formation on the teeth.
In this investigation oral physiotherapy of the tongue and palate significantly reduced oral debris. Reduction in oral debris as a result of tongue and palate oral physiotherapy retarded initial plaque formation and reduced total plaque accumulation on the teeth. Therefore, oral physiotherapy of the tongue and palate contributes to overall mouth cleanliness and is a valuable adjunctive oral physiotherapy aid.”
Tongue cleaning is a key component of the ProFresh System due to the proven effectiveness of tongue cleaning in reducing dental plaque and reducing the anaerobic bacteria that cause halitosis. The ProFresh System includes a tongue cleaner as well as instructions to brush all mouth surfaces – including the tongue – with the ProFresh Oral Rinse. Chlorine dioxide, the active ingredient in the ProFresh rinse, is a proven anti-bacterial. Removing the bacteria in the mouth by rinsing with ProFresh reduces dental plaque even further than tongue cleaning alone.
ProFresh not only eliminates halitosis, but also supports a much healthier mouth.
1Eleanor L. Gilmore, Arthur Gross, and Ronald Whitley, “Effect of tongue brushing on plaque bacteria,” Oral Surg., Vol 36, No. 2. August 1973, pp.201-204.
2Steven E. Jacobson, James J. Crawford and Walter R. McFall, Jr., “Oral physiotherapy of the tongue and palate: relationship to plaque control”, Journal of American Dental Association, Vol. 87, July 1973, pp. 134-139.