U.S. patent application number 17/486587 was filed with the patent office on 2022-01-13 for one step gingiva retraction and impression material and method.
The applicant listed for this patent is Centrix, Inc.. Invention is credited to Ryan Dubey.
Application Number | 20220008173 17/486587 |
Document ID | / |
Family ID | 1000005869344 |
Filed Date | 2022-01-13 |
United States Patent
Application |
20220008173 |
Kind Code |
A1 |
Dubey; Ryan |
January 13, 2022 |
ONE STEP GINGIVA RETRACTION AND IMPRESSION MATERIAL AND METHOD
Abstract
A dental retraction and impression system providing
self-retracting and impression taking of a prepared tooth in one
step. Paired setting materials simultaneously retract gingiva,
widen a sulcus around the tooth, and take an impression of the
tooth and margins. A low viscosity setting gingival retracting
impression material having an astringent and a high viscosity
setting impression material set together. The high viscosity
setting impression material is heavy body and has a higher
viscosity than the low viscosity setting gingival retracting
material so as to force the low viscosity setting gingival
retracting impression material into the gingival space or
sulcus.
Inventors: |
Dubey; Ryan; (Meriden,
CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Centrix, Inc. |
Shelton |
CT |
US |
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|
Family ID: |
1000005869344 |
Appl. No.: |
17/486587 |
Filed: |
September 27, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15904747 |
Feb 26, 2018 |
11160641 |
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17486587 |
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PCT/US2016/049790 |
Aug 31, 2016 |
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15904747 |
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62213749 |
Sep 3, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61C 9/0006 20130101;
A61K 6/69 20200101; A61C 9/0033 20130101; A61K 6/90 20200101 |
International
Class: |
A61C 9/00 20060101
A61C009/00; A61K 6/69 20060101 A61K006/69; A61K 6/90 20060101
A61K006/90 |
Claims
1. Paired setting dental gingival retraction impression materials
comprising: a setting low viscosity dental impression material; a
retracting agent mixed within said setting low viscosity dental
impression material; a setting high viscosity dental impression
material, wherein said setting low viscosity dental impression
material is configured to have a harder onset earlier than said
setting low viscosity dental impression material.
2. Paired setting dental gingival retraction impression materials
as in claim 1 wherein: said setting low viscosity dental impression
material has a viscosity ranging from 120,000 to 150,000 cP; and
said setting high viscosity dental impression material has a
viscosity greater than 150,000 cP.
3. Paired setting dental gingival retraction impression materials
as in claim 1 wherein: said setting high viscosity dental
impression material has a viscosity greater than 400,000 cP.
4. Paired setting dental gingival retraction impression materials
as in claim 1 wherein: said retracting agent is selected from the
group consisting of aluminum chloride, aluminum potassium sulfate,
aluminum sulfate, alum, or ferric sulfate.
5. Paired setting dental gingival retraction impression materials
as in claim 1 wherein: said retracting agent comprises aluminum
sulfate.
6. Paired setting dental gingival retraction impression materials
as in claim 5 wherein: said aluminum sulfate comprises greater than
ten percent by weight of said setting low viscosity dental
impression material.
7. Paired setting dental gingival retraction impression materials
as in claim 1 wherein: said setting high viscosity dental
impression material has a consistency sufficient to force said
setting low viscosity gingival retracting impression material into
a sulcus around the prepared tooth.
8. Paired setting dental gingival retraction impression materials
as in claim 1 wherein: said setting high viscosity setting
impression material has a first hardness when set greater than a
second hardness of said setting low viscosity gingival retracting
impression material when set.
9. Paired setting dental gingival retraction impression materials
as in claim 8 wherein: the first hardness of the setting high
viscosity impression material when set is greater than eighty on a
Shore hardness type A scale.
10. A kit for providing material for retracting gingiva around a
prepared tooth and forming an impression of the prepared tooth in a
single operation comprising: a low viscosity setting gingival
retraction impression material having a first viscosity; and a high
viscosity setting impression material having a second viscosity,
wherein the second viscosity is higher than the first viscosity;
and wherein said high viscosity setting impression material is
configured to have a harder onset earlier than said low viscosity
setting gingival retraction impression material, whereby said low
viscosity setting gingival retraction impression material is
capable of being placed around the prepared tooth and said high
viscosity setting impression material is capable of being placed
over said low viscosity setting gingival retracting impression
material and permitted to set so that gingiva surrounding the
prepared tooth is retracted simultaneously with forming the
impression of the prepared tooth.
11. A kit for providing material for retracting gingiva around a
prepared tooth and forming an impression of the prepared tooth as
in claim 10 wherein: the first viscosity ranges from 120,000 to
150,000 cP.
12. A kit for providing material for retracting gingiva around a
prepared tooth and forming an impression of the prepared tooth as
in claim 10 wherein: the second viscosity is greater than 400,000
cP.
13. A kit for providing material for retracting gingiva around a
prepared tooth and forming an impression of the prepared tooth as
in claim 10 further comprising: a retracting agent selected from
the group consisting of aluminum chloride, aluminum potassium
sulfate, aluminum sulfate, alum, or ferric sulfate mixed with said
low viscosity setting gingival retraction impression material.
14. A kit for providing material for retracting gingiva around a
prepared tooth and forming an impression of the prepared tooth as
in claim 10 further comprising: a tip having mixing portion and a
cannula; and a dental tray.
Description
RELATED APPLICATIONS
[0001] This application is a divisional of application Ser. No.
15/904,747 filed Feb. 26, 2018, which is a continuation of
International Application PCT/US2016/049790, with an international
filing date of Aug. 31, 2016, which claims the benefit of U.S.
Provisional Application No. 62/213,749 filed Sep. 3, 2015, all of
which are herein incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention relates in general to retraction of
gingiva around a prepared tooth, and particularly to a method and
material capable of providing both retraction of gingiva and
forming an impression in a single step.
BACKGROUND OF THE INVENTION
[0003] In restoring a tooth it is often necessary to retract
gingiva from around the tooth in preparation for taking an
impression of the tooth and surrounding gingiva. The impression is
used in the making of a crown, bridge, inlay, or overlay to fit
over the prepared tooth. It is essential that a good impression of
the area around the prepared tooth be taken so that the crown,
crown, bridge, inlay, or overlay fits properly on the prepared
tooth.
[0004] The retraction of the gingiva from around the prepared tooth
is often labor-intensive and difficult. There have been many
efforts to provide an easier more convenient way to retract gingiva
so that an accurate impression can be made. One such device and
method is disclosed in U.S. Pat. No. 7,942,669 entitled "Gingiva
Tissue Retraction Device and Method" issuing on May 17, 2011 to
Dragan et al., which is herein incorporated by reference. Therein
disclosed is a pre-dosed prepared cap used in gingival retraction
having an initially inactive dry astringent.
[0005] Another device and method is disclosed in U.S. Pat. No.
7,189,075 entitled "Method and Device for the Retraction and
Hemostasis of Tissue During Crown and Bridge Procedures" issuing on
Mar. 13, 2007 to Dragan et al., which is herein incorporated by
reference. Therein disclosed is a method of retracting gum tissue
by placing an initially flowable material around a tooth, covering
the tooth and initially flowable material with a dam mad of a
porous material, applying pressure until the initially flowable
material sets, and removing the dam with the initially flowable
material attached.
[0006] While these prior methods and materials made the taking of
impressions easier they involve multiple steps and have been time
consuming to perform. Therefore, there is a need for a method and
material that can simultaneously retract gingiva and take an
impression in a single operation making dentistry easier.
SUMMARY OF THE INVENTION
[0007] The present invention makes it easier to take an impression
of a prepared tooth by combining the retraction and impression in a
single operation. A first low viscosity setting gingival retracting
impression material is applied with a syringe around the interface
of the gingiva and the tooth. Soon thereafter and before the first
low viscosity setting gingival retracting impression material has
set a second high viscosity setting impression material is applied
over the first low viscosity setting gingival retracting impression
material. The setting times of the first and second material are
synchronized so they set together. The setting of the two materials
may be controlled by a chemical reaction, such as use of a
catalyst. The first and second material are then removed together
forming an impression of the gingiva and prepared tooth. The first
low viscosity setting gingival retracting impression material
preferably contains a retracting agent, such as an astringent.
[0008] It is an object of the present invention to make the taking
of a dental impression easier and quicker.
[0009] It is an advantage of the present invention that retraction
of gingiva and the taking of an impression are accomplished in a
single operation.
[0010] It is another advantage of the present invention that a low
viscosity setting gingival retracting impression material and the
high viscosity setting impression material are set and removed at
the same time.
[0011] It is a feature of the present invention that the first low
viscosity setting gingival retracting impression material and the
high viscosity setting impression material have setting times that
are synchronized so that they both set at approximately the same
time.
[0012] It is another feature of the present invention that the
first low viscosity setting gingival retracting impression material
contains a retracting agent, an astringent, or hemostatic
agent.
[0013] It is yet another feature of the present invention that the
second high viscosity setting impression material has a viscosity
higher than the first low viscosity setting gingival retracting
impression material.
[0014] It is yet another feature of the present invention that the
second high viscosity setting impression material is heavy body and
has a mousse-like consistency.
[0015] These and other objects, advantages, and features will
become more readily apparent in view of the following more detailed
description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 schematically illustrates the present invention and
application of a low viscosity setting gingival retracting
impression material.
[0017] FIG. 2 schematically illustrates the present invention and
application of a high viscosity setting impression material.
[0018] FIG. 3 schematically illustrates the placement of a high
viscosity setting impression material in a dental tray.
[0019] FIG. 4 illustrates a full dental tray.
[0020] FIG. 5 schematically illustrates the placement of a dental
tray over a prepared tooth.
DETAILED DESCRIPTION OF THE INVENTION
[0021] FIGS. 1 and 2 illustrate the present invention. In FIG. 1 a
prepared tooth 10 is surrounded by gingiva 14. A space or sulcus is
formed between or at the margin of the gingiva 14 and the surface
of the paired tooth 10. A syringe tip 16, attached to a syringe,
not illustrated, has a cannula 18 thereon. The cannula 18 may be
made of a malleable metal to facilitate placement and positioning.
The cannula 18 may have a relatively small gauge to facilitate
accurate placement of a low viscosity setting gingival retraction
impression material 20 around the perimeter, and preferably around
the entire exposed surface of the prepared tooth 10. The syringe
tip 16 preferably has a mixing portion that has an augur for mixing
two component materials. The low viscosity setting gingival
retraction impression material 20 is extruded by the syringe
through the syringe tip 16 and the cannula 18. The material 20 has
a relatively low viscosity and contains a retracting agent, such as
an astringent or hemostatic agent such as aluminum chloride,
aluminum potassium sulfate, aluminum sulfate, alum, ferric sulfate
or any other known retracting agent.
[0022] FIG. 2 illustrates the placement of a high viscosity setting
impression material 22 around the perimeter of the prepared tooth
10 on top of the low viscosity setting gingival retraction
impression material 20, illustrated in FIG. 1. The high viscosity
setting impression material 22 may be placed on top of the low
viscosity setting gingival retraction impression material 20 with a
syringe, or preferably with a dental tray filled with the high
viscosity setting impression material 22. The material 22 has a
higher viscosity than the material 20. Additionally material 22
may, but generally need not contain a retracting agent.
[0023] The low viscosity setting gingival retracting impression
material 20 has a setting time that is synchronized with the high
viscosity setting impression material 22 so that the two materials
20 and 22 will set together forming a single unitary mold. Upon
removal of the single unitary mold the impression of the prepared
tooth 10 and the gingiva 14, including the sulcus 12 is formed.
This impression may then be used as a mold in preparing a crown,
bridge, inlay or overly to cover the prepared tooth.
[0024] The low viscosity setting gingival retracting impression
material 20 preferably has a viscosity so that it can easily flow
into the sulcus 12 around the prepared tooth 10 so as to form an
accurate impression. The low viscosity setting gingival retracting
impression material 20 also contains a retracting agent so that the
gingiva 14 is retracted from the surface of the prepared tooth 10
so as to make possible the taking of a more detailed impression of
the prepared tooth 10 so as to provide a good quality impression.
The high viscosity setting impression material 22 has a higher
viscosity than the low viscosity setting gingival retracting
impression material so as to provide a heavier backing material to
gently force the low viscosity setting gingival retracting
impression material 20 into the sulcus 12. The higher viscosity
setting impression material 22 is heavy body and has a mousse-like
consistency. The higher viscosity setting impression material 22
has a stiffness sufficient to force or drive the low viscosity
setting gingival retracting impression material into the sulcus 12
around the prepared tooth 10. The high viscosity setting impression
material 22 preferably has a hardness when set greater than the low
viscosity setting gingival retracting impression material 20 when
set. The high viscosity setting impression material 22 may have a
Shore hardness type A scale greater than eighty when set. Shore
hardness is measured with a durometer. This aids in retraction and
providing a good impression. This also prevents injury to the
gingiva by providing a compliant yet firm force. The heavier
setting or high viscosity setting impression material 22 also
provides additional strength when combined or attached to the low
viscosity setting gingival retracting impression material 20 while
also facilitating the removal of the combined single unitary mold
from the prepared tooth 10 and the gingiva 14 without breaking or
separating so as to provide an accurate impression. A syringe or a
dental impression tray may be used to apply the high viscosity
setting impression material 22 to the prepared tooth 10 and the low
viscosity setting gingival retracting impression material 20.
[0025] Both impression materials 20 and 22 are preferably based on
a vinylpolysiloxane or VPS impression material. The VPS impression
material has a combination of physical properties that provide
strength, elasticity, dimensional stability, and the ability to
register detail in any environment. The VPS impression material can
provide a wide selection of viscosities and set times. The VPS
material has two components that when mixed set into a flexible
solid.
[0026] Preferably, the low viscosity setting gingival retracting
impression material is thinned to a consistency of a wash type
material having a viscosity of 120,000 to 150,000 cP or centipoise
at room temperature. For example, water has a viscosity of 0.899 cP
at 25.degree. C. This low viscosity setting gingival retracting
impression material 20 is placed by the tip 16 and syringe, not
shown, around the sulcus and over the tooth to provide retraction
as well as fine detail required for an accurate impression. The
high viscosity setting impression material 22 is a heavy body,
higher viscosity matrix having a viscosity preferably greater than
400,000 cP, or backing material and that adheres to an impression
tray and the low viscosity setting gingival retracting impression
material, facilitating simultaneous removal of both materials 20
and 22. The high viscosity setting impression material 22 has
sufficient body or viscosity to force and hold the low viscosity
setting gingival retracting impression material 20 in and around
the sulcus 12 or margin between the gingiva 14 and the prepared
tooth 10. Both materials 20 and 22 have setting times that are
synchronized so that both materials set at approximately the same
time so that they adhere together. If desired, the low viscosity
setting gingival retracting impression material 20 may be adjusted
to have a slightly longer set time substantially equal to a time
required to apply the high viscosity setting impression material 22
over the low viscosity setting gingival retracting impression
material 20, so that both materials 20 and 22 set together either
simultaneously or at approximately the same time.
[0027] An additional advantage of adjusting the set time of the low
viscosity setting gingival retracting impression material 20 longer
than the high viscosity setting impression material 22 is that as
the high viscosity setting impression material 22 sets it gets
stiffer or harder earlier than the low viscosity setting gingival
retracting impression material 20 creating more of a backing for
driving the low viscosity setting gingival retracting material 22
into the sulcus 12. This aids retraction and improves the resulting
impression.
[0028] The low viscosity setting gingival retraction impression
material 20 is preferably applied around the sulcus 12 or margin
between the prepared tooth 10 and the gingiva 14 with a syringe and
syringe tip 16. The low viscosity setting gingival retraction
impression material 20 is preferably placed over the entire exposed
prepared tooth 10 surface. The high viscosity setting impression
material 22 may be similarly applied with a syringe as illustrated
in FIG. 2, but is preferably applied by first placing it in a
dental impression tray, as illustrated in FIG. 3-5, and applied
over the prepared tooth 10 and the low viscosity setting gingival
retracting impression material 20 so as to form the impression.
Therefore, after both materials 20 and 22 set and upon removal of
the dental impression tray 24 or 30 both materials 20 and 22 are
set and remain attached together as well as attached to the dental
impression tray 24 or 28 so as to be removed in a single unit. This
single unit or single unitary impression may then be used by a
dental lab to prepare a crown, bridge, inlay, or overlay to fit
over the prepared tooth 10.
[0029] FIGS. 3-5 illustrate a preferred technique or method for
applying the high viscosity setting impression material. FIG. 3
illustrates the placement of the high viscosity setting impression
material 22 into a quadrant or partial dental tray 24 or a full
dental tray 28 having a groove or channel 30. The partial or full
dental tray 24 and 28 maybe made of a porous flexible material or a
non-porous rigid plastic material. The dental trays 24 or 28 need
only be sufficiently rigid to prevent undue flexing so as to result
in an accurate impression. The high viscosity setting impression
material 22 may be placed in the dental trays 24 or 28 with a bulk
syringe 26 having a nozzle. FIG. 4 illustrates a full dental tray
which may also be used if a full dental impression is desired. A
tray having different sizes for of any desired section or quadrant
of the mouth may be used.
[0030] FIG. 5 schematically illustrates the low viscosity setting
gingival retracting impression material 20, the high viscosity
setting impression material 22, and a partial dental tray 24
applied to a prepared tooth 10. The low viscosity setting gingival
retracting impression material 20 is placed into the sulcus 12
between the gingiva 14 and around and over the prepared tooth 10,
preferably as illustrated in FIG. 1. The partial dental tray 24 is
filled with the high viscosity setting impression material 22 and
is positioned over the prepared tooth 10 so that the high viscosity
setting impression material 22 is in contact with and covers the
unset low viscosity setting gingival retracting impression material
20. Optionally, some of the high viscosity setting impression
material 22 may be placed on the top of the prepared tooth 10 prior
to placement of the filed cap or partial dental tray 24. Adjacent
opposing tooth 32 may be used by the patient to apply pressure to
the cap or partial dental tray 24.
[0031] The present invention is a unique dental impression system
that makes taking a dental impression easier and more predictable.
The low viscosity setting gingival retracting impression material
stops fluid flow and controls bleeding and gently displaces the
soft tissue or gingiva around the prepared tooth. The low viscosity
setting gingival retracting impression material may contain more
than 10%, and preferably 15% by weight of a retracting agent, such
as aluminum sulfate. The retracting agent in combination with the
low viscosity setting gingival retracting impression material and
pressure applied by the high viscosity setting impression material
retracts the gingiva widening the sulcus adjacent the prepared
tooth creating a space permitting the low viscosity setting
gingival retracting impression material to flow therein. This
facilitates capturing all the margins resulting in a clear final
impression.
[0032] The present invention is a gingiva retraction and impression
system comprising use in combination of a low viscosity setting
gingival retracting impression material and a high viscosity
setting impression material. The system also comprises mixing
nozzles and delivery tips used in a syringe, preferably having a
mechanical advantage. The low viscosity setting gingival retracting
impression material typically comprises two components that are
mixed with a mixing nozzle and extruded through a delivery tip for
placement around the prepared tooth. The high viscosity setting
impression material also typically comprises two components that
are mixed together with a mixing nozzle and extruded through a
delivery tip. After mixing the two impression martials set. The
system also comprises a dental tray in which the high viscosity
setting impression material is placed before placement on the
prepared tooth. The two impression materials work together in a
single step to retract the gingiva and form an impression of the
prepared tooth and margins. The impression is then used in making a
crown, bridge, inlay, overlay or other dental work.
[0033] The single step gingival retraction and impression system of
the present invention may be practiced according the following
steps. Prepare the tooth for taking an impression and dry the area,
place the low viscosity setting gingival retracting impression
material into the gingival sulcus and around the tooth with a
syringe, place the high viscosity setting impression material in a
tray, placed the tray with the high viscosity setting impression
material over the unset low viscosity setting gingival retracting
impression material, apply pressure until the two impression
materials are set, typically between 3 and 5 minutes, remove the
tray together with the set two impression materials.
[0034] The present invention permits a clinician to take an
accurate impression without the need for a prior retraction step.
By combining the retraction necessary in a single step with taking
an impression, the present invention saves time and cost, as well
as makes dentistry easier.
* * * * *