Irrigating and lavage compositions

Drug – bio-affecting and body treating compositions – Dentifrices

Reexamination Certificate

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C424S054000, C424S055000, C433S086000, C433S216000

Reexamination Certificate

active

06190642

ABSTRACT:

The present invention relates especially to irrigants for use in mechanical apparatus for scaling teeth to debride and cleanse them of plaque, plague constituents and calculus, in order to mitigate the effects of periodontal diseases.
Periodontal diseases are characterized by chronic inflammation and loss of epithelial fibrous attachment between the tooth and the gum, i.e. between soft and hard tissues. The level of the attachment of the gum to the tooth is normally at the junction of the enamel and cementum, but decreases in response to the chronic inflammatory process initiated by infection with gram-negative organisms which may be found in plaque accumulations. As the level of the attachment decreases, a pocket is formed which enhances accumulation of gram negative anaerobic bacteria, favoring additional loss of gingival attachment and the enlargement of the pocket. Studies have shown that bone loss around the tooth root follows, but lags behind attachment loss. Periodontal diseases are thus typified by loss of attachment and bone which eventually may lead to tooth loss.
While plaque accumulations around the necks of teeth and subgingivally in the pockets of teeth may not be the only causative factors in decreased gum/tooth attachment and bone loss, the presence of such accumulations appears to be a necessary precursor for certain types of periodontal diseases, especially chronic adult periodontitis. If plaque is not removed, the microbiologic flora changes in character as it matures from predominately gram-positive to gram-negative. Gram-negative organisms have, as components of their cell walls, lipopolysaccharide molecules which have antigenic properties in humans. These lipopolysaccharide molecules, or fragments thereof, are also known as endotoxins because of their highly toxic properties in man. The endotoxins of many gram-negative bacteria associated with periodontal diseases, for example Bacteroides gingivalis, Actinobacillus actinomycetemcomitans, Bacteroides forsythus, Bacteroides intermedius and others have been shown to have antigenic and toxic properties in man.
Bacterial plaque may harden together with other calcific accretions to form calculus. This is made possible by high concentrations of calcium and phosphate in saliva. Thus, calculus is comprised of calcified necrosed bacteria and other calcific deposits. Calculus bound to the tooth represents a mechanical irritant. Because microbial plaque and plaque debris including endotoxin may be occluded within or bound to the calculus, calculus may also represent a toxic material with antigenic character.
Therapeutic treatment of periodontal disease ideally requires complete mechanical removal of calculus and infecting bacteria and their residues, including endotoxin bound to or occluded within plaque and calculus. Hand-scaling is slow and laborious, but offers tactile feedback to the skilled hands of the practitioner; whereas high speed scaling, wherein the vibration of a mechanically assisted scaler is generally above 10,000 cycles per second, provides for removal of calculus and reduces the effort required by the dental practitioner at the expense of tactile feedback. High speed devices and their uses are extensively documented in the literature.
An objective of the present invention is to provide irrigants which may be employed together with prior art instruments for scaling and root planing and to debride the teeth of calculus in order to augment and enhance the effectiveness of these techniques in removing and thereby mitigating the effects of irritating, toxic and antigenic effects of calculus, plaque and plaque debris, including endotoxin. A further objective is to remove sources of chronic inflammation and irritation and to cleanse the gingival sulcus of toxin laden calculus, plaque and plaque debris.
PRIOR ART DEVICES
It is known in the art to deliver antimicrobial solutions as a lavage to the sulcus or pocket affected by periodontal disease using commercially available delivery devices. An example is the Water Pik™. Such prior art devices comprise a variety of configurations to deliver lavage solutions but are not used to scale and mechanically debride teeth. Rather their benefit resides in the delivery and lavage of the antimicrobial solutions, presumably to kill plaque microorganisms and to rinse away soft, loosely adhered plaque. Generally, the irrigants chosen for use in the prior art devices are those that are available as mouthrinses with antimicrobial activity. They comprise a medicament and a vehicle or carrier. Examples of medicaments are sanguinarine, chlorhexidine, cetyl pyridinium chloride, zinc chloride, substituted phenols and the like. The selection of ingredients other than the medicaments is based generally on flavor perception and the need for stabilization of the solutions. The vehicle most frequently used comprises water and ethanol or a polyol and a surfactant as a means to keep otherwise immiscible flavoring oils dissolved, solvated or dispersed in the solution. Coloring agents and sweeteners may be present. Examples of commercially available mouthwashes used for this purpose include Listerine™, Listermint™, Scope™, Cepacol™, Peridex™ and Viadent™.
It is known in the art that plaque and calculus can be removed from teeth by mechanical scaling, especially at high frequency, including ultrasonic frequencies.
Copending application, U.S. Ser. No. 141,355, filed Jan. 6, 1988, assigned to Dentsply International Inc. incorporated herein by reference, now abandoned, discloses a delivery device for delivery of multiple irrigants to an infected site through the apex of a hollow ultrasonic scaler, to provide for simultaneous delivery of one or more irrigants and debridement while scaling the tooth. The device is intended especially for subgingival scaling, root planing and debridement at ultrasonic speeds.
Ultrasonic scalers vibrate at speeds greater than about 20,000 cps. Additionally, it is known in the art to use mechanical scalers that vibrate at lower speeds, greater than about 100 cps but less than 20,000 cps, which are known as sonic scalers. It is most common to use water as the irrigant in commercially available prior art sonic and ultrasonic scalers.
OBJECTIVES OF THE INVENTION
An objective of the invention is to provide irrigant solutions that are operative in all modes and methods of scaling but are especially valuable in sonic and ultrasonic high speed, mechanically assisted scaling methods wherein the irrigant is simultaneously delivered subgingivally to make it continuously available.
A further objective of the invention is to make available irrigants that chemically assist in the removal of plaque, plaque debris and calculus from the tooth and by doing so cleanse the tooth and pocket of antigenic and mechanically irritating deposits which are sources of chronic irritation and inflammation.
A further objective is to provide irrigants that are better able to cleanse the tooth and periodontal pockets to provide surfaces that favor epithelial reattachment between soft tissue and the tooth by producing a clean tooth surface free of calculus, microbial plaque and plaque debris and residues, especially endotoxin.
Another objective is to provide irrigating solutions that are useful in treating periodontally diseased pockets of teeth -to cleanse the tooth of calculus, bacterial plaque and plaque debris including endotoxin, and thereby reduce chronic inflammation.
Another objective is to provide irrigants affording the above advantages while simultaneously providing the adjunctive benefits of medicaments which may be added as supplementary components. These may include antiseptics, anti-microbials, astringents, anesthetics, antibiotics, anti-inflammatories, fluorides, enzyme inhibitors, monoclonal antibodies and the like, whether free in solution or contained within vesicles such as within liposomes.
SUMMARY OF THE INVENTION
The dental treatment material of the invention comprises one or more surfactants of the type that can solvate plaque and endotoxin, and preferably one or more calc

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