RETRACTION PASTE AND CONTAINER COMPRISING THE RETRACTION PASTE

Abstract

The invention relates to a retraction paste comprising a composition of i) 10 to 25% by weight at least one astringent compound, ii) 50 to 75% by weight fillers, iii) 10 to 35% by weight protic liquid, and iv) 0 to 10% by weight pigments, dye and/or rheology additive, ii) the fillers comprising kaolinite and mica in the ratio of 4:1 to 1.5:1 and, the total composition of components i) to iv) in the retraction paste amounting to 100% by weight, a method for producing the retraction paste, a kit comprising a container with the retraction paste for single or repeated use, as well as a retraction paste as an agent for haemostasis.

Claims

1. Retraction paste, comprising; i) 1 to 25% by weight of at least one astringent compound, ii) 50 to 75% by weight fillers, iii) 10 to 35% by weight protic liquid, and iv) 0 to 10% by weight pigments and/or dye and comprising rheology additive, wherein the rheology additive is present from 0.01 to 2.5% by weight in the total composition of 100% by weight, ii) the fillers comprising kaolinite and mica in the ratio of 4:1 to 1.5:1 and, the total composition of components i) to iv) in the retraction paste amounting to 100% by weight.

2. Retraction paste according to claim 1, which comprises: i) 10 to 25% by weight of at least one astringent compound, ii) 50 to 70% by weight fillers, iii) 15 to 30% by weight protic liquid, and iv) 0 to 10% by weight pigments and/or dye and rheology additive, wherein the rheology additive is present from 0.01 to 2.5% by weight in the total composition of 100% by weight, ii) the fillers comprising kaolonite and mica in the ration of 4:1 to 1.5:1 and, the total composition of components i) to iv) in the retraction paste amounting to 100% by weight.

3. Retraction paste according to claim 1, wherein ii) kaolinite has an average particle size D.sub.50 of 0.01 to 100 micrometers and optionally with D.sub.70 less than 45 micrometers.

4. Retraction paste according to claim 1, wherein ii) mica has an average particle size of 0.01 to 100 micrometers and optionally with D.sub.70 less than 4 micrometers.

5. Retraction paste according to claim 1, wherein i) the at least one astringent compound or a mixture of at least two astringent compounds comprises inorganic astringent salt comprising aluminium salt, iron (III) salt natrium chloride, manganese salt or zinc salt, heavy metal salt, as well as solvate and/or hydrate of the inorganic astringent salt, and/or organic astringent compound comprising polyphenols, polyhydroxyphenols, tanning agents, tannic acid, octenidine salt, octenidine 2 HCl, tranexamic acid (trans-4-(aminomethyl) cyclohexane carboxylic acid), 6-aminocaproic acid, chitosan, polysaccharides having a dehydrating effect, as well as solvate and/or hydrate of the organic astringent compound, and/or mixtures of at least two of the afore-mentioned astringent compounds.

6. Retraction paste according to claim 1, wherein v) 0 to 25% by weight gel forming agent, the total composition of components i) to v) in the retraction paste amounting to 100% by weight.

7. Retraction paste according to claim 1, wherein iii) the protic liquid comprises water, C1 to C4 alcohols, C1 to C4 polyols and mixtures of at least two of the afore-mentioned compounds.

8. Retraction paste according to claim 1, wherein iii) the protic liquid is water.

9. Method for producing the retraction paste according to any one of claim 1, comprising mixing the components: i) 10 to 20% by weight of at least one astringent compound, ii) 50 to 75% by weight fillers, the fillers comprising kaolinite and mica in the ratio of 4:1 to 1.5:1, iii) 10 to 30% by weight protic liquid, and iv) 0 to 10% by weight pigments, dye and/or rheology additive, and the total composition of components i) to iv) in the retraction paste amounting to 100% by weight.

10. Kit comprising a container, the container comprising a syringe, syringe cylinder, cartridge or ampoule, the container each comprising a retraction paste according to claim 1.

11. Kit according to claim 10, wherein the kit comprises a cartridge with canula (11), a syringe having a screw connection (5), a syringe having a Luer lock connection, a syringe having a bayonet connection (9) or an ampoule having a plunger and an ampoule closure (18).

12. Kit according to claim 10, comprising a canula having a screw connection, canula having a Luer lock connection, or a canula having a bayonet connection for connecting with the screw connection, Luer lock connection or the bayonet connection of the syringe or a canula for fastening at the ampoule closure.

13. A method for treating a medical condition in a patient in need thereof, said method comprising applying a retraction paste according to claim 1 to the patient.

14. Method according to claim 13, which is carried out for the treatment of bleedings of the gingiva in the patient and the retraction paste is applied to the patient as an agent for haemostasis.

Description

DESCRIPTION OF THE FIGURES

[0116] FIGS. 1a and 1b show a clinical example fora gingival retraction of the sulcus 3 by means of a retraction paste;

[0117] FIGS. 2a and 2b show a kit each comprising a syringe 5 having a screw connection and a syringe 9 having a bayonet connection;

[0118] FIGS. 3a and 3b show cartridges 11 having a canula 13 as well as a composite gun 14 with inserted cartridge 11 having a canula 13;

[0119] FIGS. 4a and 4b show a cylinder piston syringe 15 having a cylinder ampoule 17 as well as an ampoule 18 having a displaceable plunger;

[0120] FIGS. 5a to 5d show use of the retraction paste 4 according to the invention.

EMBODIMENTS OF THE INVENTION

[0121] FIG. 1a represents a clinical example in which an exposed ground tooth stump 1 with preparation margin and bleeding sulcus 3 and surrounding gingiva 2 form the starting situation for application of a retraction measure. The sulcus 3 of the gingiva is then filled with retraction paste 4 according to the invention for preparation of the sulcus for taking an impression of the preparation margin of the ground tooth stump. FIG. 1b shows the retraction paste 4 in the sulcus of the gingiva 2. The retraction paste 4 has been syringed in the sulcus around the tooth stump and its preparation margin. The whole preparation process in the bleeding sulcus is explained in more detail in FIGS. 5a to 5d.

[0122] FIG. 2a represents a kit comprising a syringe 5 having a screw connection the syringe cylinder 6a of which is filled with the retraction paste according to the invention. A canula 7a having an inside thread as screw connection and a blunt canula 7b is distally fastened to the screw connection 8 of the syringe 5. FIG. 2b represents a syringe 9 having a bayonet connection. The syringe body 9a distally has a bayonet connection 10, a canula 7b having a bayonet connection and a blunt canula 7a is fastened to which. The two syringes 5 and 9 have a proximally situated handle 5a or 9a, respectively, wherein the retraction paste can be applied through the blunt canula 7a into a sulcus by pressing and sliding in the syringe piston 6b or 9b, respectively. The retraction paste is obtainable in cartridges, ampoules or syringes and is applied into the gingival sulcus via a canula. The retraction paste is left there for about 2 minutes, subsequently rinsed out with water, see FIG. 5d. Subsequently, the sulcus may be carefully dried using an air blower.

[0123] FIG. 3a represents cartridges 11 having a canula 13 and a put-on closure 12. The cartridges are filled with retraction paste. FIG. 3b shows a composite gun 14 or PLT dispenser, respectively with inserted cartridge 11 having a canula 13.

[0124] FIGS. 4a and 4b show a cylinder piston syringe 15 having a cylinder ampoule 17 as well as an ampoule 18 having a displaceable plunger and an ampule closure 20.

[0125] FIG. 4a shows a cylinder piston syringe 15 having a cylinder ampoule 17, canula 16a having a connection and a bent blunt application canula 16b for the cylinder piston syringe 15. A cylinder ampoule 17 is inserted into the cylinder piston syringe 15. The cylinder piston syringe 17 has an inlet seat 17a for a cylinder ampoule 17, piston rod with handle 17b, screw thread for canula 17c, cylinder ampoule holder 17d, distal end, in particular with aspiration hooks 17e of the piston rod of the cylinder piston syringe, joint having a folding mechanism for opening the cylinder ampoule holder 17f, handle e.g. finger support 17g, piston rod 17h, knurled-head screw 17i for fastening the ampoule 17 at the distal end of the piston rod of the cylinder piston syringe, and a handle e.g. thumb plate ring 17j. A cylinder piston syringe enables a very controlled pressure application and thus a high-precision discharge of the retraction paste by means of displacing the displaceable plunger 19 in the cylinder ampoule 17 or ampoule 18, respectively, via the canula into the sulcus. An ampoule 18 has a closure 19 that is removed before insertion into the cylinder piston syringe 15.

[0126] FIGS. 5a, 5b, 5c and 5d show a kit according to the invention of a syringe 5 having a screw connection that has a syringe cylinder filled with a retraction paste according to the invention, a retraction gel is also synonymous to a retraction paste. The syringe cylinder 6a of the syringe 5 is filled with retraction paste. The syringe has a handle 5a as well as a screwed-on canula 7a having a blunt bent canula 7b. The retraction paste 4FIGS. 5b and 5cis syringed into the bleeding sulcus 3FIG. 5aor the sulcus is filled with haemostatic retraction paste 4, respectively, via the blunt and bent application canula 7b. Then, the astringent effect of the retraction paste leads to haemostasis in the widened sulcus. The paste causes the sulcus to remain widened by means of its defined adjusted viscosity and stability. The added astringent agents, such a aluminum chloride, causes haemostasis.

[0127] FIG. 5c represents a combination of thread techniques and retraction pastes. In case of a deeper and wide gingival sulcus, usually a thread having a smaller diameter is initially inserted into the sulcus to displace the gingiva vertically. The thread shall comprise the whole circumference of the tooth stump without overlapping of the thread ends. The retraction paste 4 is inserted into the sulcus via the thread 21 being laid around the tooth stump 1 and subsequently dilates the sulcus, so that the preparation margin is exposed for later impression.

[0128] In FIG. 5d, the retraction paste is removed from the sulcus after sufficient application time using water or an air-water-stream. The water and the washed away retraction paste is removed with a water-suction appliance 25. After that, the sulcus is dry blowed using a smooth compressed air stream. The sulcus is then dilated 22, i.e. the astringent sulcus is widened and ready for an impression.

[0129] FIG. 5d after removal of the retraction paste 4, the sulcus 3 is dilatated, dry and free of blood. The preparation margin is well accessible and can be impressed with high accuracy. Any customary impression material can be used for impression. Flexitime can be used for subsequent impression of the tooth stump as impression material to impress the subgingival preparation margin. In this case, a corrective impression, if appropriate, can be more suitable due to the higher dynamic pressure than a one-sided impression procedure, as especially in precision impression of a subgingival preparation margin it can be the case that the dynamic pressure is too low in one-sided impression to press a sufficient amount of the low viscosity impression material into the sulcus difficult to access.

[0130] The retraction paste according to the invention has a very good consistency and convinces in a very easy time-saving handling as well as a low after-bleeding, in particular a prolonged haemostasis as well as an effective sulcus opening.

LIST OF REFERENCE NUMERALS

[0131] 1 ground tooth stump with preparation margin [0132] 2 gingiva [0133] 3 sulcus (bleeding sulcus) [0134] 4 retraction paste [0135] 5 syringe having a screw connection [0136] 5a handle of the syringe [0137] 6a syringe cylinder [0138] 6b syringe piston/syringe plunger with handle [0139] 7a canula, screwable canula 7a or canula having a bayonet connection [0140] 7b blunt bent application canula [0141] 8 screw connection at syringe cylinder [0142] 9 syringe having a bayonet connection [0143] 9a syringe cylinder having a bayonet connection [0144] 9b Syringe piston/syringe plunger with handle [0145] 10 bayonet connection [0146] 11 cartridge with canula 13 and closure 12 for the canula 13 inlet nozzle [0147] 12 closure for canula at cartridge [0148] 13 canula at cartridge [0149] 14 composite gun [0150] 15 cylinder piston syringe [0151] 16a canula having a connection for cylinder piston syringe 15 [0152] 16b application canula [0153] 17 cylinder ampoule [0154] 17a inlet seat for cylinder ampoule [0155] 17b piston rod with handle [0156] 17c screw thread for canula [0157] 17d cylinder ampoule holder [0158] 17e distal end of the (aspiration hooks) piston rod of the cylinder piston syringe [0159] 17f joint having a folding mechanism for opening the cylinder ampoule holder [0160] 17g handle e.g. finger support [0161] 17h piston rod [0162] 17i knurled-head screw for fastening the ampoule at the distal end of the piston rod, of the [0163] cylinder piston syringe [0164] 17j handle e.g. thumb plate ring, controlled pressure application [0165] 18 ampoules having a displaceable plunger 19 and having an ampoule closure 20 [0166] 19 ampoule plunger [0167] 20 ampoule closure [0168] 21 thread under retraction paste [0169] 22 astringend dilated sulcus ready for impression [0170] 25 water-suction applicance