# US 10,478,383 B2 · Sterilizable dental rool canal filling composition, points/cones made of same, and process of sterilizing same

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- Number: US 10,478,383 B2
- Document ID: US10478383B2
- Status: Granted
- Kind: B2
- Application number: 15/201,383
- Filed: 2016-07-01
- Published: 2017-01-26
- Granted: 2019-11-19
- Earliest claimed: 2015-07-01
- Assignees: DENTSPLY SIRONA Inc.
- Applicants: Tulsa Dental Products LLC
- Inventors: Nathan Y. Li
- Web page: https://patentgrep.com/patent/US10478383B2

## CPC

- A61K 6/54: Filling; Sealing
- A61C 5/50: Implements for filling root canals; Methods or instruments for medication of tooth nerve channels
- A61K 6/17: Particle size
- A61K 6/802: comprising ceramics
- A61L 2/081: Gamma radiation
- A61L 2103/05: Living organisms or biological materials
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

A root canal filling cone made of a material having a composition that can maintain its physical and chemical characteristics and shelf life after sterilization, and a process of sterilizing the point/cone prior to shipment to a user. In one aspect, the cone is made of a composition that includes a plurality of base polymers of substantially equal amounts, and nanoparticles, which can withstand sterilization by gamma irradiation. In one embodiment, the compound includes Gutta Percha based polymers. In another aspect, the Gutta Percha based cone is packaged and sterilized by irradiation prior to shipment to a user. In one embodiment of the present invention, the irradiation is gamma irradiation.

## Claims

### Claim 1

A root canal filling composition, comprising:
a plurality of Gutta Percha polymers having different Mooney index values;
an antioxidant of particles having a particle size of 1000 nm or less; and
a filler of particles having a particle size of 1000 nm or less,
wherein the composition can substantially maintain its physical and chemical characteristics and shelf life after sterilization by irradiation.

### Claim 2 (depends on 1)

The composition as in claim 1, wherein the plurality of Gutta Percha polymers comprise at least three Gutta Percha polymers, each having a different Mooney index values.

### Claim 3 (depends on 2)

The composition as in claim 2, wherein the plurality of Gutta Percha polymers comprise Gutta Percha polymers having at least Mooney index values of 20, 50 and 100.

### Claim 4 (depends on 3)

The composition as in claim 3, wherein the plurality of Gutta Percha polymers comprise about equal proportions of Gutta Percha having the different Mooney index values.

### Claim 5 (depends on 1)

The composition as in claim 1, wherein the filler comprises at least two groups of filler particles having substantially different particle sizes.

### Claim 6 (depends on 5)

The composition as in claim 5, wherein the filler comprises a first group of filler particles having a particle size of about 20-30 nm.

### Claim 7 (depends on 6)

The composition as in claim 6, wherein the first group of filler particles is less than 0.3% by weight of the composition.

### Claim 8 (depends on 5)

The composition as in claim 5, wherein the filler comprises a second group of filler particles having a particle size of 700-900 nm.

### Claim 9 (depends on 8)

The composition as in claim 8, wherein the second group of filler particles is less than 15% by weight of the composition.

### Claim 10 (depends on 5)

The composition as in claim 5, wherein the antioxidant comprises particle sizes of 300-800 nm.

### Claim 11 (depends on 10)

The composition as in claim 10, wherein the antioxidant is less than 1% by weight of the composition.

### Claim 12

A root canal filling composition, comprising:
Parts
By
% By
Weight
Component
weight
weight
(g)
a first Gutta Percha polymer
33.33
7.75% (+/−10%
333.33
variation)
a second Gutta Percha polymer
33.33
7.75% (+/−10%
333.33
variation)
a third Gutta Percha polymer
33.33
7.75% (+/−10%
333.33
variation)
Wax
2
0.46%
20.0
an antioxidant - High T,
2
0.46%
20.0
300-800 nm particle size
Nano ZnO
1
0.23%
10.0
20-30 nm
particle size
BaSO4
60
13.95%
600.0
(radiopaque)
ZnO (inert
212.5
49.42%
2125.0
biocompatible
filler; not
nano-sized)
Color Yellow
3.3
0.77%
33.0
Color Red
0.2
0.05%
2.0
Nano ZnO
49
11.38%
490
700-900 nm
particle size
Total:
430
100%
4300.

### Claim 13 (depends on 1)

A cone for a dental root canal filling, comprising:
a body having a generally axisymmetric conical structure, wherein at least a section along the body has a tapered structure, wherein the body is made of a material having a composition as claimed in claim 1.

### Claim 14 (depends on 13)

A method of sterilizing a cone for dental root canal filling as claimed in claim 13, comprising:
subjecting the cone to irradiation.

### Claim 15 (depends on 14)

The method of claim 14, wherein the cone is subject to gamma radiation.

### Claim 16 (depends on 15)

The method of claim 15, further comprising sealing the cone in a package prior to subjecting the package containing the cone to gamma irradiation.

### Claim 17 (depends on 16)

The method of claim 16, wherein the gamma irradiation is in the range between 5 kGy to 20 kGy.

### Claim 18 (depends on 17)

The method of claim 17, wherein the gamma irradiation is in the range between 8 kGy to 13 kGy.