Novel Protection Against Contamination by Microbial Pathogens

Abstract:

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One of the principles of wound care is the use of wound dressings.  Modern wound dressings are designed to protect wounds from contamination and potential infection, provide pain relief, and promote the healing process. Safe and truly effective wound dressings for the mouth have never been developed because of the unique challenges presented by the mouth.  Currently used topical products provide inadequate pain relief, or they hinder the healing process, or worse, present toxicities and/or negative side effects.  Sockit Oral Hydrogel Wound Dressing is a drug-free, non-toxic hydrogel that provides excellent pain relief, and promotes optimal healing.  Micro studies also demonstrate Sockit Gel’s superlative effectiveness against various microbial oral pathogens.  Sockit Gel thus allows the dentist to offer truly excellent post-operative care by safely and effectively providing pain relief, promoting healing, and, importantly, protecting against microbial contamination.

Introduction

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Oral wound care has always been inadequate in dentistry.  This situation has been accepted as a matter of fact to the point that many, if not most, dentists do not even think about wound care, much less provide it in their practices.  Wounds almost always eventually heal, after all, and our patients do well enough with what we have been doing (which is basically nothing).  The problem with this attitude is that we, as doctors, are ethically (and legally) obligated to provide the best care we can to our patients.  “OK” is not good enough, when “ideal” is readily available. 

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Traditionally, after oral surgery, dentists provide a prescription for narcotics or recommend over-the-counter (OTC) pain medications.  Some may recommend an antimicrobial rinse to protect from microbial contamination.   Other than that, little has been routinely offered to our patients.  Unfortunately, pain medications, even narcotics, provide inadequate pain relief.1,2  In addition, narcotics have the potential for abuse, as is seen in the current opioid crisis in America, and OTC meds can be toxic.  For example, acetaminophen overdose is the leading cause of acute liver failure in the US.3

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A fundamental principle of wound care is the use of wound dressings, a long-accepted practice in medicine.  Simply put, with rare exceptions, wounds should be dressed.  In medical settings, to leave an open wound exposed would be considered malpractice.  Historically, wound dressings consisted of inert bandages that had three primary functions: physically protect the wound, maintain optimal moisture, and prevent microbial contamination.  Today, additional benefits are often expected of wound dressings, such as controlling microbial growth, enhancing the healing process, and others.4  So, many modern wound dressings are bioactive.  As such, wound dressings include standard bandages, gels, sprays, etc.

Dentists should provide ideal wound care for their patients, but the question is…how?  It is one thing to develop a wound dressing adequate for caring for a person’s arm, it is an altogether different issue when the mouth is concerned.  The reasons are simple and obvious...the mouth is wet, it is busy, and it is the major portal to the body.  A traditional bandage will not stay in place in the mouth due to its inherent moist environment.  Also, the tongue itself and/or the process of eating would easily dislodge a standard wound dressing.  In addition, the ingredients needed to control microbial growth or to provide pain relief more often than not have toxicities, and should not be swallowed.  Added to that is the almost ubiquitous cytotoxicity of these ingredients and their adverse effects on wound healing.  So, safety, as well as efficacy, are major hurdles to overcome for adequate oral wound care.

To address each of these issues, Sockit Oral Hydrogel Wound Dressing was developed to safely and effectively address three major requirements for wound care.  Sockit Gel is approved by the FDA for all wounds, lesions, etc, of the mouth.  Sockit Gel: 

• Provides excellent pain relief (without numbing the mouth)

• Protects from contamination

• Promotes optimal healing

Sockit Gel is unique in its composition, consisting of 100% all-natural, plant-based food ingredients, at or below the concentrations found in foods.  Sockit Gel thus contains no drugs or synthetic molecules, and no animal product.  Food, by definition, is non-toxic; therefore, Sockit Gel is non-toxic, which sets it apart from almost every other product used in oral care.

More than 13 years on the market has proven Sockit Gel’s place in dentistry.  The excellent pain relief provided by Sockit Gel, with little or no need for pain medication, and no toxicities or potential for abuse, is a major advancement for dentistry.2  The reduction in healing time provided by Sockit Gel is an added benefit and results in fewer postoperative complications.

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Protection from contamination provided by Sockit Gel is the third benefit that is extremely important in oral wound care.  The mouth is not a nice place to have a wound.  More than 700 species of bacteria and various fungal and viral species have been identified in the human mouth.5  Many of these are potential pathogens that can cause infections.  In addition to the obvious negatives associated with microbial colonization is a delay, or in the case of true infection, cessation in wound healing.6  

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Antimicrobial rinses, mouthwashes, etc., are often recommended to address this issue.  However, almost all of these are toxic to some extent and should not be swallowed.  Also, because they are almost all very toxic to the cells of wound healing, they can also delay healing.7  Chlorhexidine, for example, is one of the most cytotoxic agents for wound care used in medicine and dentistry.  Studies have demonstrated its deleterious effects on fibroblasts and other cells of wound healing, which explain its notorious reputation for delayed healing, and its inhibition of reattachment of epithelium after periodontal surgery.8–12  It is prudent to remember that oral chlorhexidine is approved only for the treatment of gingivitis.

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Sockit Gel is a multi-use product, so it had to undergo the United States Pharmacopoeia (USP) <51> Preservative Challenge Testing.  This 28-day, standardized test is required by law to ensure that microbial contamination of the product will not occur during the time of use.   This test demonstrates that the product will not promote the growth of the following common opportunistic microorganisms: Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger.  Sockit Gel passed this test, else it could not be marketed. (see Table below)
 

Sockit Gel vs Peridex Time Kill Studies

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Because Sockit Gel consists entirely of food ingredients, which would naturally elicit concerns when used after oral surgery, more testing was done against potential pathogenic bacterial and fungal species that are commonly found in the mouth.  Sockit Gel was tested versus chlorhexidine gluconate (Peridex).  Bacterial species from various genera were chosen for these tests, including those implicated in dental caries, periodontal disease, endodontic infections, and pharyngitis (strep throat).  Three candidate species were also tested.  Counts were made after exposure to Sockit Gel or Peridex at 30 seconds, 5 minutes, 30 minutes, and 1 and 6 hours.  Inoculation levels ranged from ~500,000 CFU/gm to more than 1.5 million CFU/gm.   The term CFU (colony forming unit) describes a live, viable cell (capable of reproduction).  Both products completely killed all species by 30 minutes, so the table below shows results after exposure for 30 seconds and 5 minutes. (see table below)

Streptococcus mutans is a major player in the development of tooth caries, as is Streptococcus sobrinus.13  Sockit Gel produced complete kill in both species by 30 seconds, while Peridex still allowed some growth with S. sobrinus.

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More than 400 different species of microorganisms reside in the gingival crevice;14 however, Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Bacteroides forsythus (now renamed Tannerella forsythia), and Fusobacterium nucleatum are four of the most pathogenic and prevalent isolates implicated in periodontitis.15–18  As seen in the chart below, within 30 seconds, Sockit Gel produced a complete killing in all four species.  Peridex also performed very well, with only slight growth still present with A. actinomycetemcomitans and F. nucleatum.

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Enterococcus faecalis is implicated in up to 90% of endodontic infections and up to 77% of root canal failures.19,20  Both sodium hypochlorite and chlorhexidine gluconate are used to fight E. faecalis during root canal treatment; however, both agents have shown low ability to eliminate this species.21  Sockit Gel demonstrated superior activity against E. faecalis, compared to Peridex. 

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S. pyogenes is found in the oropharynx and can cause streptococcocal pharyngitis (strep throat).  Strep throat can progress to scarlet fever, rheumatic fever, glomerulonephritis, and other serious conditions.22 Sockit Gel demonstrated superior activity against S. pyogenes, compared to Peridex.

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Candida albicans, Candida glabrata, and Candida tropicalis are yeast-like fungi that occupy the oral cavity and can cause various oral and systemic candidal infections (candidiases).23 These may be life-threatening, especially in immunocompromised individuals.  Sockit Gel eliminated all three species within 30 seconds, while Peridex still allowed growth in all three species at 30 seconds, and with C. glabrata and C. tropicalis, at 5 minutes.

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Infective endocarditis is a rare but serious bacterial infection associated with high morbidity and mortality, despite antibiotic treatment.  The viridans group of streptococcus (VGS) are the principal organisms implicated in the induction of IE (up to 60% of endocarditis cases are attributed to VGS).24  Among these are S. mutans and S. sobrinus,  also well-known for their roles in dental caries (see above).25 Within 30 seconds, Sockit Gel produced the complete killing of both species.  Peridex completely eliminated all S. mutans within 30 seconds but did not completely kill all S. sobrinus.

Discussion

Sockit Gel is made entirely of plant-based food ingredients at or below concentrations normally found in food.  The natural preservative system consists of the essential oils of cinnamon, clove, and thyme.  Essential oils are antibacterial and antifungal and have activities against certain enveloped viruses, such as herpes simplex.  Even in the small concentrations in Sockit Gel (~ 1% that of the food source), these essential oils are synergistic and very effective, as seen in the results above.26
 
Sockit Gel provides three major benefits required for optimal wound care: excellent pain relief within minutes of application, promotion of wound healing, and protection from microbial contamination.  In addition, because it consists of 100% plant-based food ingredients, Sockit Gel is non-toxic and is safe when swallowed.  It has no potential for abuse.  Another advantage over Peridex is the fact that Sockit Gel does not stain teeth, restorations or tissues.  No other single product provides these benefits of safety and efficacy.  Dentists for the first time have the means to provide excellent oral wound care for their patients.  

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Sockit Gel is ideal for all tooth extractions, periodontal procedures, implants, graft procedures (bone and soft tissue), laser procedures, as well as restorative and hygiene procedures.  Patients love the pain relief without the need for pain medication, and dentists love the significant reduction in non-productive chair time. Sockit Gel is also billable and codable, so it represents a new income stream for the dentist.  

Sockit Gel is an innovative product that gives the dentist the ability to provide the safest and most effective oral wound care available in the world today.

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