Non-toxic organic compositions and calcium hydroxide compositions thereof

Claim 2

A polymerizable composition which is substantially non-toxic toward living pulpal and bone tissue and dentin and which is polymerizable in situ by a mechanism other than chelation or saponification while in contact with living pulpal tissue, said composition comprising at least one polymerizable monomer or prepolymer component and a catalytically effective amount of a curing component for said monomer or prepolymer component.

Claim 3

The composition of claim 1, wherein said polymerizable composition comprises at least one polymerizable ethylenically unsaturated monomer or prepolymer, and a catalytically effective amount of a free radical initiator system, whereby preferably said monomer or prepolymer component, as well as said polymerizable composition, is substantially non-toxic toward said pulpal and bone tissue and dentin both before and after said composition is polymerized, said non-toxicity being observable either by in vitro cell culture biocompatibility testing utilizing monolayers of mouse fibroblast cells (L929 or equivalent) in a growth medium consisting of 5% bovine serum solution in Minimum Essential Medium (MEM) or by in vivo histological response testing using prepared teeth of a primate, preferably of Cynomolgus fascicularis.

Claim 4

The composition of claim 2, wherein said at least one polymerizable ethylenically unsaturated monomer or prepolymer comprises at least one polymerizable vinyl urethane monomer or prepolymer derived from a member selected from the group consisting of adducts of organic diisocyanates or isocyanate-terminated urethane prepolymers and an ethylenically unsaturated compound having hydroxyl functionality, preferrably an ester of acrylic or methacrylic acid and a hydroxy alkanol of at least two carbon atoms, and adducts of organic polyols or hydroxyl terminated prepolymers and an ethylenically unsaturated compound having isocyanato functionality, and preferably selected from the group of vinyl urethanes or prepolymers derived from hexamethylene diisocyanate and hydroxypropyl (meth)acrylate, from trimethyl hexamethylene diisocyanate and hydroxypropyl (meth)acrylate, from the reaction product of methylene- bis-(4-cyclohexyl isocyanate) and a polytetramethylene ether glycol with hydroxypropyl (meth)acrylate, and mixtures thereof.

Claim 5

A biocompatible composition, particularly according to Claims 1 to 3, characterized in that it contains a vinyl urethane prepolymer characterized by the structural formula wherein R 1 and R 5 , independently, are H, alkyl or substituted alkyl; R 2 and R 4 , independently, are alkylene, substituted alkylene, cycloalkylene, substituted cycloalkylene, arylene, or substituted arylene; and R 3 is alkylene, substituted alkylene, cycloalkylene, substituted cycloalkylene, arylene, substituted arylene, heterocyclic, substituted heterocyclic, the reaction product of an organic diisocyanate or an isocyanate terminated prepolymer and a compound having hydroxyl functionality, or the reaction product of a polyol or a hydroxyl terminated prepolymer and a compound having isocyanato functionality, whereby preferably R 1 and R 5 , independently, are H or C 1 -C 4 alkyl; R 2 and R 4 , independently, are C 1 -C 6 alkylene; and R 3 is C 1 -C 6 alkylene, C 2 -C 12 substituted alkylene, or the reaction product of an organic diisocyanate or polyisocyanate with an alkanol or polyalkanol and whereby more preferably R 1 and R 59 independently, are H or -CH 3 ; R 2 and R 4 , independently, are -CH 2 -CH 2 -CH 2 -, or -CH 2 -CH 2 -; and R 3 is , where R 6 , R 7 and R 8 , independently, are H or -CH 3 .

Claim 6

The composition of claims 3 or 4, wherein said at least one polymerizable ethylenically unsaturated monomer or prepolymer comprises a mixture of at least one polymerizable vinyl urethane prepolymer and at least one ester of acrylic acid or methacrylic acid, preferably a diacrylate, a dimethacrylate, a polyacrylate or a polymethacrylate, and mixtures thereof and most preferably triethylene glycol dimethacrylate.

Claim 7

The composition of claims 1 to 5, wherein said free radical initiator system comprises a photoinitiator system, preferably operative in response to exposure to visible light, notably light having a wavelength in the range of from about 360 to about 550 nm, whereby more preferably said photoinitiator system comprises an α-diketone, preferably camphoroquinone, and a reducing agent which is capable of reducing said α-diketone when the latter is in an excited state.

Claim 8

The composition of claim 6, characterized by from about 0.001 to about 10% by weight and preferably from about 0.01 to about 5% by weight of the α-diketone based on the polymerizable unsaturated material in the composition whereby said reducing agent is an amine, preferably present in an amount of from about 0.1 to about 5% by weight based on the polymerizable unsaturated material, and wherein said composition is in the form of a shelf-stable one package system.

Claim 9

The composition of claims 1 to 7, comprising up to about 90 and preferably up to about 85% by weight of filler and whereby said filler is or comprises preferably a radiopaque filler in an amount sufficient to render said composition radiopaque, preferably in an amount of from about 5 to about 30% by weight.

Claim 10

The composition of claim 8, wherein said polymerizable composition comprises a filler selected from the group consisting of barium sulfate, radiopaque barium or strontium oxide glasses, colloidal silica, fused quartz, aluminum oxide, ceramic beads, glass beads, calcium phosphates, metal silicates and aluminosilicates and mixtures thereof, preferably in an amount of from about 45 to about 90% by weight.

Claim 11

The composition of claims 8 or 9, wherein said polymerizable composition comprises calcium hydroxide or calcium oxide or mixtures thereof, preferably in an amount of from about 3 to about 70% and preferably about 5 to about 30% by weight of said composition and preferably with an average particle diameter of said calcium hydroxide or calcium oxide or mixtures thereof of from about 0.02 to about 20p.

Claim 12

The composition of claim 10 further comprising inorganic filler in addition to said calcium oxide or calcium hydroxide or mixtures thereof, said inorganic filler having an average particle diameter of from about 0.02 to about 20p and being selected from the group consisting of colloidal silica, fused quartz, aluminum oxide, ceramic beads, glass beads, calcium phosphates, metal silicates and aluminosilicates and mixtures thereof.

Claim 13

The composition of claims 1 to 11, containing from about 1 to about 99.8% by weight and preferably from about 15 to about 95% by weight and especially at least about 30% by weight of said at least one polymerizable ethylenically unsaturated material.