Introduction

Dental treatments and methods, including gum and peri-implant diseases, use peroxide gels and viscous antibacterial/antimicrobial agents to chemically debride and curettage treatment areas for natural teeth or implants. These treatments include non-surgical scaling and root planing with dental or medical tools such as periodontal scalers and/or curettes during the active period of the chemical/mechanical debridement. The working surfaces of dental tools should be controlled sharpened and refinished for optimal root and tooth surfacing during treatment. Treatment can include instructions for co-therapy between visits and for maintenance care.

Classic studies have shown that clinicians' ability to fully decontaminate the tooth root decreases as probing depth and bone loss increase. Even after multiple episodes of scaling and root planing, additional calculus removal showed no difference between single attempts versus multiple attempts. Even when access is possible, some defects are too deep to clean with conventional instrumentation, preventing tissue repair/regeneration.

Even experienced clinicians who access a root surface with flap surgery are sometimes limited in the amount of detoxification that can occur due to the depth of the defect and conventional instrumentation. Further limitations with mechanical access to defects can come in the form of furcations with multirooted teeth, which can make access difficult. Molars with bone loss that includes furcations are often downgraded in prognosis due to this access difficulty.

In 2017, the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP) updated the 1999 guidelines and classifications for diagnosing periodontal disease and developed new classifications for peri-implant diseases. The new classification was comprehensive in discussion but very little was said regarding the treatment options for the various diseases. Periodontal treatment has been shown to increase tooth survival rates in advanced bone loss situations, with most tooth loss due to failed endodontic procedures, root fractures, poor iatrogenic dentistry, and/or noncompliance with recommended hygiene and treatment intervals.

Enhanced Scaling and Root Planning

As a treatment method for periodontal and implant-related issues, overcoming historical limitations for tissue repair and regeneration around severely diseased teeth and implants. The novel technology and methods have been able to surmount these restrictions by applying appropriate antimicrobial/antibiotic containing viscous gel solutions to the working ends of periodontal instruments during all phases of periodontal therapy (Phase I, Phase II, and Phase III).

This innovative treatment method allows clinicians to enhance their clinical skills and treatment outcomes while benefiting patients from less adverse events associated with other treatment approaches. The fully autoclavable custom designed Cutting Edge Technology Honing Channel Sharpening Stones create the finest smoothest cutting edges on instruments and can be quickly re-sharpened when necessary chairside during clinical non-surgical and surgical procedures in as little as one stroke. Orthopedic, neurosurgical, and other extensive instrument designs have been developed in collaboration with the medical manufacturing industry.

Once the patient's open treatment plans are completed by their Restorative dentist, Endodontist, or other needed specialties, no new dental diseases develop post treatment for the vast majority of patients. A tailored individualized maintenance plan is developed with the patient becoming an active co-therapist at home, eliminating or minimizing future dental repair work and controlling biofilms.

The newly patented and patent-pending technology provides both a pleasant painless experience with no additional topical or injectable anesthetic needed, whether in Periodontal Phase I or Periodontal Phase III Treatment for a Preventative Periodontal and Dental Maintenance cleaning protocol. It does not require the use of Sonic or Ultra Sonic handpieces nor electronic Sonic or Ultrasonic Scalers that could create blasts of water and oral derived bacteria/viral/microorganisms.

These innovative pharmaceutical products have been in long-term use with proven documented success and effectiveness for both Periodontal non-surgical and surgical procedures and are user-friendly. No local injection anesthetics are needed as the applied Topical Pharmaceutical Gels contain the needed topical local anesthetic pain relief. The prepared pharmaceutical viscous Gels are applied directly onto scaling and root planing and other periodontal probing instruments while performing procedures whether supragingivally or subgingivally, treating periodontal diseases on tooth root surfaces or implant surfaces for a more pleasant experience for both patient and clinician.

Enhanced root planing can also mean a treatment procedure that includes mechanical root planing together with chemical debridement using viscous chemical treatments and antimicrobials. Viscous chemical treatments can include those provided in a viscous form, such as a peroxide gel, or chemical treatments that become viscous when administered for treatment.

In summary, "enhanced" mechanical planing and controlled surface finishing also includes controlled finishing for tools and other biological and implant surfaces, such as root surfaces, bone surfaces, tissue surfaces, or implant surfaces.

The American Dental Association's specialty organization, the American Academy of Periodontology (AAP), emphasizes the importance of periodontal health in the least invasive and most cost-effective manner. This is often achieved through non-surgical Phase I periodontal treatment, including root planing and scaling. Root planing is a separate procedure that can be performed at the same time as scaling, but is optimally performed at separate appointments when reevaluation of periodontal therapy healing is repeatedly checked at each remaining pocket site in the dentition from the initial scaling during multiple visits of Phase I periodontal therapy.

Enhanced root planing is a definitive treatment procedure designed to remove cementum or surface dentin that is rough, impregnated with calculus, or contaminated with toxins or microorganisms. It helps allow a patient's oral tissues, such as periodontal tissues and supporting bone, to repair and regenerate on the tooth root surfaces of the dentition. Dental instruments with refined functional optimized working surfaces are used for enhanced root planing, which should be similar to the white enamel of a tooth, kitchen glass, or other smooth surface to minimize bacterial growth and help prevent repopulations of microorganisms on the root.

For most patients of advanced periodontal disease, the favorable reduction in disease parameters occurs when root planing and scaling or enhanced root planing is performed repeatedly for each tooth for each of 4-6 visits over 4-6 months. Clinical research indicates significant periodontal health improvements with recordings of bacterial scores, bleeding on pocket probing, probing pocket depths, and probing attachments levels following 4-6 months after start of therapy. For some patients, additional time resulted in further improvements in clinical periodontal parameters where pocket probing depths decreased from 8-9 mm down to 3-4 mm, with restoration of clinical health.

Early research by Beaumont RH, et al. showed that there appears to be no appreciable difference in resistance to disease between a long junctional epithelial adhesion and a true connective tissue attachment. Gingival health was maintained in both groups by daily brushing and prophylaxis.

Many patients experience little or no discomfort when root planing and scaling are done by an experienced periodontal clinician and require no anesthetics for pain or discomfort. However, when pocket depths with clinical disease parameters persist at some teeth despite the non-surgical approach, periodontal surgery is indicated to visibly ensure that the root planing is thoroughly performed to allow for pocket probing depths to return to the 1-3 mm normal range and complete this root planing treatment task properly.

Periodontal debridement is defined as the removal of all subgingival plaque and its by-products, as evidenced by clinical signs of inflammation, clinically detectable plaque retentive factors (calculus, overhangs), and detectable calculus-embedded cementum. Reevaluation of healing following periodontal debridement is the key mechanism for ascertaining efficacy by evaluating the periodontal tissues for the elimination of inflammation, absence of bleeding upon probing, and levels of attachment and gingival recession. Long-term success requires cooperative maintenance care by both the patient and the clinician.

The reevaluation of the response to Phase I treatment is necessary after a suitable length of time as to resolution of inflammation and bleeding upon probing. If reevaluation following initial, nonsurgical therapy indicates that areas of the mouth have teeth with persistent inflammation and infection that is still not resolved or disease progression has occurred, a clinical decision must be made regarding the reason(s) for nonresponse and the need for further therapy including site-specific periodontal surgery. Problems with self-care by the patient at home, inflammation or residual calculus and biofilms may require reinstruction, redebridement, or in some rare occasions a different chemotherapeutic approach. Surgical and further non-surgical therapy may be needed on a site-specific basis.

The past and current research literature evaluates most periodontal treatments including chemotherapeutic agents in human and animal clinical trials with very limited research population trials (most with less than 100 patients, or animals) and longevity (most 6 months or less), with minimal significance of results to assess with good statistical conclusions the success for long-term lifetime care. In contrast, embodiments described in the present disclosure are supported by testing and work with thousands of periodontally active disease tooth sites in thousands of patients, and is informed by the understanding that long-term success requires continued cooperative maintenance care by both the patient as a co-therapist. clinical workflow and chairside procedures.

Figure 1. Clinical setup for Enhanced Root Planing using CET technology at chairside

In periodontal diseases, microbial pathogens trigger inflammatory host responses which, along with direct irritation by bacterial products and byproducts, cause most of the destruction to the periodontium. The host must first recognize at some threshold level, and react to bacterial irritants for the disease to develop and progress. In most infections, the immune system localizes the invasion site and attempts to rapidly neutralize, destroy, or remove the foreign bacterial derived agents. The long-term presence of the bacteria plaque and its maturation with developing microbial colonization causes a persistent and excessive host response that can varies in intensity depending upon host susceptibility. Research continues to identify susceptibility and who is “at risk” as well as identification of specific risk factors.

After the 4 to 6 visits spread over 4 to 6 months or more (as needed) of repeated scaling and root planing, reducing the number of active disease sites by this repeated effort at each remaining active disease pocket site or recession site and with gradual reductions in pocket probing depths noted at each visit initial periodontal therapy, the periodontal probing depths are recorded again and again. Site-specific therapy is the goal: decisions made after no further favorable changes are noted after the usual 4-6 month period. However, site-specific treatment planning may require additional time for some treated areas while others are ready for long-term maintenance care, while still others need Phase II therapy or other forms of dental care.

Furcation involvements are a common finding in advanced periodontitis cases, and the management of these findings should focus on creating an environment that maintains hygiene and enhances the patient's capacity to maintain optimal oral hygiene. This can be achieved through combined chemotherapeutic/biomechanical intervention during Phase I, II, and II.

During and following completion of Phase I Therapy, Phase II (surgical) Therapy, and future visits for Phase III (maintenance therapy), a detailed re-evaluation should be made using the aforementioned and the following guides. The purpose of the re-evaluation is to carefully assay the response of gingival tissues to initial therapy—Phase I Therapy—including removal of calcareous deposits, oral supra and sub gingival biofilms (bacterial plaque control), oral physiotherapy, temporary stabilization, occlusal adjustment by selective grinding, orthodontics, endodontics, etc., to determine the subsequent treatment that may be indicated. As each clinician's observations are recorded, the treatment that may follow should follow, such as periodontal osseous surgery, mucogingival surgery with augmentation techniques, tissue guided regeneration, autogenous and allographic bone grafting, etc.

Local therapy includes biofilm removal, treatments to reduce the conditions for biofilms accumulation, elimination of traumatized tissue to increase chances of bone regeneration and attachment, and creating occlusal relations that are favorable to periodontal tissue. Systemic therapy is an adjunct to local therapy targeted to specific treatment issues, such as controlling systemic complications from acute infections, chemotherapy to prevent harmful effects of post-treatment bacteremia, supportive nutritional therapy, and control of systemic diseases that can aggravate periodontal treatment or may require special precautions. Conventional systemic therapy includes systemic antibiotics to eliminate bacteria that invade gingival tissue and may reinvade and repopulate the pocket.

A dental treatment method comprising providing a gel solution including a peroxide gel, for example a Bio-Edge10% Carbamide Peroxide/Antimicrobial Viscous Solution. This formulation is a patented technology protected under United States and international Patent Cooperation Treaty (PCT) filings and includes one or more clinically validated antimicrobial agents, for administration to a treatment area of a subject in conjunction with a dental care treatment; and providing a viscous antibacterial agent including a clinically effective amount of tetracycline to the treatment area of a subject during the dental treatment. The peroxide gel solution chemically debrides and anesthetizes the treatment area.

The method disclosed in this embodiment consists of administering a gel solution including a peroxide to a periodontal pocket of a subject in conjunction with a mechanical debridement treatment, wherein the peroxide gel solution chemically debrides and anesthetizes the treatment area of the periodontal

pocket. Additionally, administering a viscous antibacterial agent consisting essentially of tetracycline to the periodontal pocket of a subject during the mechanical debridement treatment is also described.

Various peroxide gels can be used, such as hydrogen peroxide gels, carbamide peroxide gels, or any other agent that will undergo debriding oxygenation. The gel concentration of peroxide can range from 1.5% to 44%. The method also includes the use of sharpening tools to provide optimized functional working surfaces for dental instruments, such as optimized blades or cutting edges. These optimized dental instruments and working surfaces are influential in controlling or limiting bacterial growth rates and the potential for selective bacterial flora attachments to roots by controlled surface roughness along with the microbiological rates of other organisms such as virus fungi amoebas and other parasites. This can enhance the effectiveness of antimicrobials and antibiotics as well as surgical regenerative and surgical epithelial and connective tissue repair and root reattachment procedures during Phase I, Phase II, and Phase III treatments.

The tetracycline can be powdered tetracycline, which can be administered directly into the periodontal pocket before and/or during the mechanical debridement, where it obtains a viscous, paste-like consistency. A medicament comprising the solution and the antibacterial agent can be administered in conjunction with the treatment. The treatment can comprise nonsurgically treating advanced periodontitis, such as in furcation sites such as molars and some bicuspids. Trays and other delivery mechanisms do not reach these pockets nor adapt and fit under the clinical tooth enamel crown.

The Bio-Edge10% Carbamide Peroxide/Antimicrobial Viscous Solution. This formulation is a patented technology protected under United States and international Patent Cooperation Treaty (PCT) filings and includes one or more clinically validated antimicrobial agents as anesthetic is applied in an amount effective amount to forestall the need for injected anesthetics such as lidocaine (xylocaine). This allows the treating periodontist to apply the treatment at pocket depths ranging from more than 3 mm to at least 5 mm without the need for other anesthetics, including up to at least 7-10 mm. Conventionally, periodontists would need to introduce a topical or injection of known anesthetics such as lidocaine or Novocain or stronger anesthetics for such aggressive mechanical debridement.

Root desensitization products should also be used first where root instrumentation is a concern at specific tooth sites that could result in discomfort and thus avoid the use of local anesthetics for pain management. It is expected that embodiments of the technology and methods described herein will justify changes in standards of care.

Properly sharpening the working edges of dental tools, such as curettes and other scalers, reduces even further the need for powerful anesthetics. Treatment, when administered in conjunction with properly sharpened dental tools with functional optimized working surfaces, can smooth tooth root surface to 1-5 microns—down to 1 micron. Root conditioning to this degree of smoothness makes the root inhospitable to bacteria and pathogens as the bacteria cannot attach to the root.

Repeated application of the chemical debridement properties of the gel was able to non-surgically treat many pocket sites at 5mm and even greater, to over 10 mm, without surgery. Smoothing the roots to as close as 1 micron root results in surface finishing that is as smooth as possible. Removing various bacterial and non-bacterial substances supragingivally and in the exposed pocket/sulcus helps reduce the future bacterial recolonization of smooth root surfaces.

Figure 2: Sequential radiographs for Tooth #19 showing Pre-op condition (09/23/2019), Fitted Master Points, and Final restoration (10/09/2019) during root canal treatment.

One notable case involves a patient who presented with advanced periodontitis on Tooth #19. Sequential radiographs captured the progression from initial root canal therapy through to final obturation and crown placement. As seen in Figures 2, the root canal treatment was meticulously executed, setting the stage for periodontal rehabilitation using CET-enhanced protocols. This included Bio-Edgeapplication during root planing, and repeated use of sharpened curettes to maintain a smooth root surface. Over the course of treatment, the tooth transitioned from mobility and inflammation to complete clinical stability.

The unique chemical approach described in the present invention aims to achieve a chemical curettage and root conditioning that improves the removal of bacterial and non-bacterial substances. This combination of antibacterial and antimicrobial approaches, along with the use of optimally sharpened tools, results in successful treatment and future preventive management of periodontal and dental caries/decay prevention. Periodontal treatments include a battery of professionally and patient-administered antimicrobial agents, mechanically intraorally, to control supra and subgingival colonization of periodontal and caries pathogens for various types of diseases.

A dental treatment method comprises providing a gel solution including a peroxide gel, such as Bio-Edge10% Carbamide Peroxide/Antimicrobial Viscous Solution. This formulation is a patented technology protected under United States and international Patent Cooperation Treaty (PCT) filings and includes one or more clinically validated antimicrobial agents, for administration to a treatment area of a subject in conjunction with a dental care treatment. Additionally, a viscous antibacterial agent including a clinically effective amount of tetracycline is administered to the treatment area during the dental treatment. The gel concentration of peroxide can range from as little as 1.5% to as much as 44%.

The use of sharpening tools to provide optimized functional working surfaces for dental instruments is also described. These optimized dental instruments and working surfaces are influential in controlling or limiting bacterial growth rates and the potential for selective bacterial flora attachments to roots by controlled surface roughness. This can enhance the effectiveness of antimicrobials and antibiotics, as well as surgical regenerative and surgical epithelial and connective tissue repair and root reattachment procedures during Phase I, Phase II, and Phase III treatments.

Tetracycline can be powdered and administered directly into the periodontal pocket before and/or during the mechanical debridement, where it obtains a viscous, paste-like consistency. A medicament comprising the solution and the antibacterial agent can be administered in conjunction with the treatment.

The treatment can comprise nonsurgically treating advanced periodontitis, such as in furcation sites such as molars and some bicuspids. The extent of periodontal attachment loss, whether hard or soft tissue, can be a determining factor in periodontal probing of pocket depths.

Teeth such as molars and some bicuspids can also have furcation involvements between their multiple roots, which can be further defined with loss of periodontal bone attachment and soft tissue attachments to their root surfaces with periodontal probing.

The text describes various embodiments of dental treatments that aim to provide optimal periodontal care. These treatments require root surfaces to be made as smooth and biologically clean as possible, minimizing bacterial repopulation and maturation of bacterial plaque, which is responsible for Dental Caries and Periodontal Diseases. Research has shown the importance of using properly sharpened and finished curettes during biomechanical root preparation in periodontal therapy. The highest grit number produced the smoothest and sharpest cutting edges, with aluminum oxide and Arkansas stones being the most suitable abrasives.

Quirynen and Bollen reported on the influence of surface roughness and surface-free energy on subgingival plaque formation in humans. They found that rough surfaces promote plaque maturation, while high-energy surfaces collect more plaque, bind it more strongly, and select specific bacteria. The current unifying world document on proper periodontal treatment modalities endorses and quotes the work and ideas of this extensive review article.

The influence of surface roughness overrules surface-free energy, as the subgingival environment allows more microorganisms to survive, diminishing the importance of surface characteristics. However, the demand for smooth surfaces with low surface-free energy to minimize plaque formation and reduce the occurrence of dental caries and periodontitis in the world population justifies the demand for smooth surfaces with low surface-free energy.

In some embodiments, dental treatments include sharpening a dental instrument working surface with a sharpening tool configured to produce a cutting edge that optimizes the working surface of the blade. This can be done during mechanical debridement, such as enhanced root planing, using abrasives that sharpen dental instruments, making the roots of teeth very smooth to minimize biofilm repopulations on root surfaces. Antimicrobials and antibiotics can also be used during treatment, such as topically applied carbamide peroxide gel and tetracycline. Patients or caregivers can also regularly use antimicrobials, such as Bio-Edge10% Carbamide Peroxide/Antimicrobial Viscous Solution. This formulation is a patented technology protected under United States and international Patent Cooperation Treaty (PCT) filings and includes one or more clinically validated antimicrobial agents and topical fluorides, on the roots to minimize dental decay risks.

In conjunction with each treatment, dental tools are sharpened to fine cutting edges, replicating the smoothness and sharpness of the functional working surface of the tool on the root surfaces. The optimized dental tool can then be used together with the pharmaceutical methodology described to achieve greater success and minimize the periodontal disease index and the caries disease index.

In some embodiments, mechanical treatments involve smoothing the roots using enhanced root planing to as close as a 1-5 micron root surface, which removes various bacterial and nonbacterial substances, treating disease supragingivally and in the exposed pocket/sulcus and preventing disease by reducing future bacterial recolonization of root surfaces.

Since 1995, advancements in research and development have led to the development of optimized sharpening tool technology, which has resulted in engineered channels for properly reshaping or resharpening European or American curettes and sickle scalers. The Honing Channel™ Sharpening Systems for curettes and sickle scalers include high-strength, custom-designed aluminum oxide sharpening and shaping stones with built-in tolerances to accommodate most curettes and scalers used by dental professionals worldwide.

The optimized sharpening tool technology improves the quality and delivery of dental treatment and healthcare by preparing dental instruments for clinical use based on current accepted professional standards and advanced professional standards of care. These tools consistently provide the smoothest and sharpest cutting edge on any metal alloy, ceramic, or plastic manufactured instrument by anyone who uses it. Dental research studies indicate that the smoothness of the root surface in periodontal treatment is directly determined by the smoothness and finish of the cutting edge of the dental instrument.

However, new dental curettes and scalers are not properly finished as they come from the manufacturer, and require proper finishing first to remove wire edges found on the cutting edges of these new instruments before they are used in treatment. As few as 15 to 30 strokes on the root of a tooth can appreciably dull and damage a cutting edge, and therefore, the instrument's cutting edge constantly needs correction with reshaping and re-sharpening during the patient's visit.

The use of optimized tool technology, such as the Honing Channel™ sharpening and shaping channels, allows licensed medical/dental clinicians to sharpen chairside during patient care delivery and now permits non-licensed technicians in the lab or sterilization/technician area to sharpen and have them ready for use in treatment with all types of curettes and scalers with less than one hour of training.

No matter who uses the product on the medical/dental team, the same correct consistent sharp highly refined cutting edge will be created true to its original geometric design for consistent quality care, unlike with earlier and conventional ‘flat stone’ sharpening technology used up to today.

Figure 3: CET Honing Channel™ sharpening system used for maintaining curette precision.

Please click here to view complete article