The effect of Breezy candy on halitosis - A double-blind randomized study

Halitosis (bad breath) is a common condition socially crippling vast parts of the population that results mainly from the malodorous compounds volatile sulfur compounds, by products of oral bacteria. In the present doubled blinded randomized study we have evaluated 75 subjects with halitosis. The participants were treated with or without abrasive microcapsules containing Zinc gluconate 0.5%, propolis 2% and a combination of both ( Zinc 0.25% , propolis 1%). The halitosis was assessed by an Halimeter at 4 different points of time Results: Breezy candy was found effective in treatment of halitosis for up to 4 hours. While treatment with regular candy ( group 1 candy without abrasive particles ) showed reduction in malodor of 10 % , Breezy's candy showed reduction of up to 60% in malodor. Breezy candy with the Abrasive form and Zinc additive had the best potential to positively affect malodor when treating patients suffering from Halitosis. The combined effect of abrasion by microcapsules with Zinc supplement represents a novel and successful approach for the treatment of halitosis Introduction Bad breath (Halitosis) is a common condition symptom that affects significant parts of the population. It is a multifactorial condition which may result from many sources such as inflammatory processes of the upper respiratory system , GI tract and oral bacteria. Oral production of malodorous substances is associated with by-products of bacterial degradation and occurs on oral surfaces, in periodontal pockets, and the dorsal tongue surface (1). . The major malodorous compounds are termed volatile sulfur compounds (VSCs), with hydrogen sulfide, methyl mercaptan, and dimethyl sulfide accounting for the majority of the VSCs (32). Many oral bacteria, from subgingival plaque, produce a diverse array of malodorous compounds as by-products of their metabolism including VSCs and shortchain organic acids , manifested mainly at the posterior part of the tongue (Fig 1) . Species that produce such malodorous compounds include Treponema denticola,Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythensis, Porphyromonas endodontalis, and Eubacterium species (2). Halitosis has been correlated with the presence and severity of periodontal disease and by the amount of coating on the tongue (3, 4). Various methods of measuring halitosis have been suggested, including organoleptic odor rating schemes (smelling the breath) (4) and analytical techniques involving gas chromatography, mass spectrometry, and cryoosmoscopy (4).. The use of a portable sulfide monitor called a Halimeter to quantitate the levels of VSCs in mouth breath was introduced by Rosenberg and have shown that these levels significantly correlate with the measurements made by organoleptic odor rating schemes (5). Treatments of bad breath include removing bacteria and bacterial waste products by scrapping the tongue and teeth with fluoride toothpaste and daily tongue debridement with a toothbrush or other mechanical device, alone or in combination with the use of antimicrobial mouth rinses such as chlorhexidine..Few reports have also suggested a beneficial effect of zinc compounds in the form of chewing gums, rinses or adhesive tablets The purpose of the present study was to evaluate the combined effect generated by the scrapping affect of candy manufactured in a microcapsules technology that releases chemical substances upon dissolving. Specifically we evaluated the combined effect of Zinc and propolis Material and Methods The study was approved by the Institutional Review Board. Randomization procedure :Each enrolled subject was given a sealed envelope containing the randomly chosen candy (one of 5 options). Each envelop was marked by a number randomly distributed according to a computerized random permutation system. Blinding procedure: Both the participating subject and the investigator were blinded to the type of the candy chosen to the treatment. All documentations in the CRF relating to the treatment were designated by the envelope's number only. Coding was not broken during the entire study A total of 75 subjects were enrolled to the study. Subjects who have met the selection criteria, and have signed the informed consent The inclusion criteria:18 years and older, healthy who suffer from halitosis Subjects were asked to refrain from food, or using mouth wash or teeth brushing for 10 hours prior the first visit. The exclusion criteria: Subjects who suffer from diabetes, renal disease, on chemotherapy, medications, smokers, had oral diseases for the last 3 month, pregnant or using dentures. Patients were randomly divided into 5 study groups 15 subjects in a group as follows: 1. Control group: This group was treated by commercial lollipop Candy, without the abrasive capabilities and without any additional antibacterial substances. 2. Abrasive candy alone: This group was treated by the Breezy Candy, which is equipped by the abrasive vesicles only, without any additional anti bacterial substances. 3. Abrasive candy with Propolis 2%: This group was treated by the Breezy Candy, which is equipped by the abrasive vesicles as well as by the encapsulated Propolis. 4. Abrasive candy with Zinc gluconate 0..5%: This group was treated by the Breezy Candy, which was equipped by the abrasive vesicles as well as by the Zinc. 5. Active ingredients Propolis 1% and Zinc 0.25% with the abrasive candy. This group was treated by the candy consisting Propolis and Zink with the abrasive vesicles. .All groups were evaluated for halitosis during 4 different session at a one week interval Prior to the appointment for odor assessment, subjects were asked to refrain from oral activities, including eating, drinking, and chewing, for 10 hrs, and from brushing and mouth rinsing for the same period. They were remained quiet and maintained a closed mouth for a period of 30 sec.. Malodor Assessment by Halimeter The subject was instructed to close his/her mouth and keep his/her lips sealed in preparation for sampling mouth air. Halimeter measurements were taken by a trained nurse 3 times for each visit, and the mean values of each visit were used for the analysis..