WHAT IS BAD BREATH and HOW DOES BREATHRx HELP?

Oral malodor has become an important public concern because of its potential significance in individual's oral hygiene and personal social life. The purpose of the study was to compare the efficacy of BreathRx2 Mouthrinse to two commercially available rinses and a placebo on clinical outcomes of changes in organoleptic and Halimeter® measurements in a four-week, randomized, double-blind, longitudinal clinical trial in adults.


The active ingredient of the two commercially available mouthrinses was essential oil (EO) or chlorine dioxide plus zinc (CD/Zn). The four rinses were coded as Product 1,2,3 and 4 so that neither the examiners nor subjects had knowledge of treatment. Subjects were provided with standard fluoride toothpaste and standard soft toothbrushes for use during the experimental period. Ninety-nine subjects who met the study criteria were assigned randomly to one of the four groups. Demographic information and medical history were collected from each subject. At each of the three visits (0, 2 and 4 weeks), subjects received an examination of oral soft tissues and were assessed for baseline oral malodor by two organoleptic judges and a Halimeter®. Subjects were then instructed to use the assigned rinse, and the organoleptic and Halimeter® measurements were performed again after 2 and 4 hours, respectively. Throughout the 4-week study period, the subject was asked to use the assigned rinse twice daily, per manufacturer's recommended directions for use, and to keep a daily diary as the documentation of the compliance. The results showed that the four mouthrinses tested reduced oral malodor within four hours after a single usage, with BreathRx2 being the most effective and the placebo being the least effective. Daily use of EO, CD/Zn and placebo rinses for up to four weeks did not reduce oral malodor from week 0 baseline values, and the effects on oral malodor were comparable among these three mouthrinses. BreathRx2 was the only mouthrinse that reduced oral malodor from baseline values after two and four weeks of daily use. It is concluded that BreathRx2 Mouthrinse is effective in reducing oral malodor and its efficacy is significantly superior to that of the commercial EO and CD/Zn mouthrinses tested in the present study.

Halitosis or oral malodor is a condition which involves offensive odor emanating from the mouth and other hollow cavities such as the nose and sinuses. This is differentiated from bad breath which emanates from the lungs when certain foods are digested. Small odor molecules from these foods (usually onions, garlic and peppers) enter the bloodstream with some making their way into the lungs. These are then exhaled causing bad breath. Oral malodor is generally caused by volatile sulfur compounds ( VSC's ) which are gases with unpleasant odors even at very low concentrations. These VSC's consist primarily of hydrogen sulfide, methyl mercaptan, dimethyl sulfide and dimethyl disulfide. VSC's caused by Gram-negative bacteria are usually associated with oral conditions contributing to a shift from Gram-positive bacteria to Gram-negative bacteria. When this happens, sulfur containing amino acids are hydrolyzed by Gram-negative anaerobic bacteria in an alkaline environment. Production and release of these VSC's and subsequent detection of these oral malodorous substances appears to depend on multiple local factors which include:

Reduced ambient oxygen concentration

Substrate available for bacterial metabolism

Bacterial production

Food particles and sloughed off oral cellular debris (substrate materials) are the main sources of protein in the oral cavity. In a healthy mouth, dead epithelial cells are shed into the saliva, swallowed and digested fast enough so that the epithelial cells do not putrefy and cause halitosis. Decreased saliva levels lead to excess food and cellular debris build up creating substrate and an increase in Gram-negative bacteria on the tongue and in gingival crevices. Decreases in saliva can also cause the pH of the mouth to increase over 7.2. An increase in the oral pH leads to higher levels of colonization of Gram-negative bacteria.

• Physiological
• Transitory
• Morning Breath
• Hunger Breath
• Menstrual Breath
• Food / Drugs
• No systemic illness
• Less intense
• Distinct in quality
• Generaly responds to oral hygiene
• Pathological
• Chronic
• Mouth
• Nose / Sinuses
• Tonsils / Pharynx
• Digestive System
• Systemic illness
• More intense
• Nondescript
• Requires treatment of underlying cause

There are two types of oral malodor physiological (transitory) and pathological (chronic). Physiological malodor tends to be less persistent and generally responds to good oral hygiene practices. Pathological malodor is more intense and persistent.

The underlying cause of the halitosis must be treated for the patient to get a significant reduction in odor levels. In physiological halitosis, this decrease in saliva and increase in oral pH can be associated with age, hunger, morning breath, menstrual cycle or drug use (See Table 1).

The underlying causes in pathological halitosis can be in the oral cavity, the nose or sinus, the tonsils, the digestive organs or can also originate from the regional or systemic pathosis such as diabetic ketosis, gastritis, gastric ulcer, oesophagitis, pyloric stenosis or hepatitis.4,5 If the patient has frequent and excessive postnasal drip, this may be a contribute to a persistent daytime oral malodor (See Table 2).

The most likely source of bad breath in individuals with good oral hygiene and healthy periodontal tissues is the back of the tongue. The oral cavity is the main contributor to bad breath in 85 percent of patients with halitosis. Approximately 10 - 15 percent of chronic halitosis is linked to more serious diseases with sinusitis and diabetes being the two most common ones. Halitosis caused by these types of diseases has distinct smells that can help lead to a specific diagnosis ( See Table 3 ).

TABLE 1 Drugs that cause dryness of the mouth contribute to bad breath CNS agents Antiparkinsonians Antipsychotics Narcotics Antidepressants Others Antihistamines / decongestants Anticholinergics Antihypertensives

TABLE 2 Oral Conditions Causing Oral Malodor Periodontitis | Apthous ulcers Dental abscesses | Candidiasis Xerostomia | Gingivitis Traumatic ulcers | Herpetic infections Oral cancer | Poor oral hygiene Non Oral Sources Causing Oral Malodor Nose | Sinuses | Tonsils | Pharynx Digestive Organs Pulmonary Systemic Illness Psychiatric Diabetic Ketoacidosis Liver Failure | Renal Failure Schizophrenia Olfactory reference syndrome

TABLE 3 - GENERAL INFORMATION Disease Psychiatric Diabetes Liver failure Acetone, fruity Sweetish, musty, “amine” odor resembling a fresh cadaver Acute rheumatic fever Acid, sweet Lung abscess Foul, putrefactive Blood dyscrasias Resembling decomposed blood Liver cirrhosis Resembling decaying blood Uremia, kidney failure Ammonia or urine Toxemia, gastrointestinal disorder, neuropsychiatric Varies, poor oral hygiene intensifies the odor Fever, dehydration, macroglobulinemia Odor due to xerostomia with poor oral hygiene and toxic waste products accumulated Sjorgen’s syndrome, Syphilis Fetid Eosinophilic granuloma, Letter-Siwe disease, Hand-Schuller-Christian disease Fetid breath and unpleasant taste Scurvy Foul breath of fudodpirochetal stomatitis Wegner’s granulomatosis Necrotic, putrefactive Diphtheria, dysentery, measles Extremely foul odor resembling acute necrotising Pneumonia, scarlet fever, tuberculosis, syphilis Gingivostomatitis, but much more intense and fetid

Zytex™, the special ingredient complex in BreathRx products, contains three active ingredients: zinc chloride, thymol and eucalyptus oil. This combination neutralizes extra volatile sulfur compounds (VSC's) and kills the Gram-negative bacteria responsible for their formation. Zinc chloride has been shown to be one of the most effective deodorants for malodor in orally healthy populations. It causes a significant reduction in VSC's7. Aqueous solutions of zinc salts in mouth rinses reduce and inhibit VSC formation in the oral cavity1,8. Zinc has an affinity to sulfur and odorizes sulfhydryl groups with zinc ions forming stable mercaptides with the substrate, the precursors, and/or the VSC's directly 9. Thymol and eucalyptus are phenolic oils which are known to have antibacterial effects10. Specifically, studies have shown that thymol has an antagonistic effect against Staphylococcus aureus, Salmonella typhimerium, Streptococcus mutans, S. sanguis, S. mitis, and S. milleri as well as Prevotella buccae, P. oris and P. intermedia11.