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Endocem - operation manual (英语, English)

6-28-endocemMTA.jpg

 

This product was developed for regenerative endodontic treatments such as partial pulpotomy; and is designed to prevent irritation of pulp and secondary

infections.

 

INDICATION:

1. Lining of cavity in pulp capping;

2. Lining of cavity in partial pulpotomy;

3. Lining of cavity after pulpotomy of deciduous teeth;

4. Canal filling for apical closure in apexogenesis;

5. Restoration of root canal perforation;

6. Restoration of internal resorption lesion; and

7. Root-end filling.

 

INSTRUCTIONS FOR USE:

1. This product should be limited to use for designated purpose only.

2. Single use only. This product should not be re-used because it deteriorates quickly when exposed to air.

3. This product should be applied immediately after mixing.

4. This product corrodes and discolors if contact is made with saliva or tissue fluid for a long period after being set and should be covered and protected

   appropriately.

 

PRECAUTIONS:

1. This product is intended for use by dental professionals and it shall only be used for the intended purpose of dental root canal filling.

2. This product must be stored in a dry place to prevent premature hardening by exposure to moisture.

3. This product must be kept tightly closed until its use to prevent premature hardening by exposure to moisture.

4. This product should be used immediately after mixing.

 

PRECAUTIONS BEFORE USE:

1. Before using this product, check whether there is any defect in packaging or any damage.

2. Do not use this product in patients with known allergies to any components of product.

 

DIRECTIONS FOR USE :

 

Direct pulp capping:

1.       Isolate the tooth with rubber dam and form cavity prep using a high speed bur and avoiding tissues close to pulp. 

2.       Remove decay closest to pulp thoroughly with a new sterilized high speed diamond bur. 

3.       Rinse the cavity prep and pulp exposure site sufficiently with copious amount of 5.25% NaOCl.  If bleeding occurs, control bleeding by compressing with NaOCl soaked cotton pellet.

4.       Mix ENDOCEM with newly unsealed distilled water or saline and fill the cavity with the mixture.

5.       If bleeding occurs, apply a thin layer of ENDOCEM first and control bleeding by pressing it with a cotton pellet.  Then apply the remaining ENDOCEM.

6.       Remove excess moisture with a dry cotton pellet; and press and pack the mixture.

7.       After setting is complete, apply a strong stream of water on the hardened ENDOCEM with a 3 way syringe to check for wash-out.  If any material is washed away, remove the restoration in its entirety and refill the cavity.

8.       Form a cavity of ENDOCEM that does not disrupt the line angle of the cavity with proper instrumentation. When doing so, all the dentinal tubules close to the pulp should be covered by ENDOCEM, with a minimum thickness of 3 mm.  At the end of this step the crown restoration should be completed.

9.       Take a radiograph to confirm whether any ENDOCEM inadvertently entered the pulpal chamber.  If so, prescribe medication for pain control. If radiographically discernible dead space exists, remove the restoration in its entirety and perform the process over again.

10.    Cover ENDOCEM with opaque flowable resin or glass ionomer to avoid contamination with saliva.

 

Partial pulpotomy of anterior teeth :

1.       Isolate the tooth with rubber dam and form cavity prep using a high speed bur and avoiding tissues close to pulp. 

2.       Remove decay closest to pulp thoroughly with a new sterilized high speed diamond bur, with irrigation. 

3.       Open the pulpal chamber and remove pulp up to the appropriate depth with a new sterilized high speed diamond bur, with irrigation.  While doing so remove remaining pulp tissue on axial walls thoroughly.

4.       Rinse the cavity prep sufficiently with copious amount of 5.25% NaOCl until bleeding stops.  Thorough cleansing is necessary, as excessive bleeding may cause discoloration of ENDOCEM.

5.       Mix ENDOCEM with distilled water and apply a thin layer of the mixture into the prepped cavity.

6.       Remove excess moisture with a sterile cotton pellet, and gently pack it to avoid dead space.

7.       Before ENDOCEM hardens, add the rest of the ENDOCEM to fill the cavity.

8.       After setting is complete, apply a strong stream of water on ENDOCEM with a 3 way syringe to check for wash-out.  If any material is washed away, remove the restoration in its entirety and proceed to root canal treatment as retreatment may cause pulpal infection.

9.       Remove the top part of ENDOCEM partially and apply resin or glass ionomer using standard of care methods.

 

Partial pulpotomy of posterior teeth :

1.       Isolate the tooth with rubber dam and form cavity prep using a high speed bur and avoiding tissues close to pulp, with irrigation. 

2.       Remove decay closest to pulp with a new sterilized high speed diamond bur, with irrigation. 

3.       Open all pulp horns with a new sterilized high speed diamond bur, with irrigation. Thoroughly remove the remnant pulp tissue on the axial wall of the cavity.

4.       Rinse the formed cavity thoroughly with 5.25% NaOCl until bleeding stops.

5.       Mix ENDOCEM with distilled water and apply a thin layer in the cavity prep.

6.       Remove excess moisture with a sterile cotton pellet, and gently pack it to avoid dead space.

7.       Before ENDOCEM hardens, add the rest of the ENDOCEM to fill the cavity.

8.       After setting is complete, apply a strong stream of water on the ENDOCEM with a 3 way syringe to check for wash-out.  If any material is washed away, remove the restoration in its entirety and proceed to root canal treatment as retreatment may cause pulpal infection.

9.       After preparation of the tooth, remove part of the exterior of ENDOCEM, and apply resin or glass ionomer using standard of care methods.  When doing so, a minimum 3 mm layer of ENDOCEM must remain in close proximity to pulp to protect from secondary infection.

 

Pulpotomy of deciduous teeth:

1.       Isolate the tooth with rubber dam and form cavity prep using a high speed bur and avoiding tissues close to pulp, with irrigation. 

2.       Remove decay closest to pulp with a new sterilized high speed diamond bur, with irrigation. 

3.       Open the pulp chamber and remove pulp tissue thorough with a new sterilized high speed diamond bur.

4.       Rinse the formed cavity thoroughly with 5.25% NaOCl.

5.       Mix ENDOCEM with newly opened distilled water or saline and fill the prepared pulp chamber with the mixture.

6.       After setting is complete, apply a strong stream of water on the ENDOCEM with a 3 way syringe to check for wash-out.  If any material is washed away, remove the restoration in its entirety and proceed to root canal treatment as retreatment may cause pulpal infection.

7.       Complete preparation of the tooth, and place crown.  Glass iornomer or resin may be used for core build-up if needed.

 

Repair of perforation

1.       Isolate the tooth with rubber dam, enlarge and irrigate the canal by using appropriate instrumentation and NaOCl.

2.       Dry the canal with paper point, and check where perforation occured in the canal. If

bleeding occurs, control the bleeding with appropriate methods.

3.       Mix ENDOCEM with newly opened distilled water.  If not available, saline may be used.

4.       Place ENDOCEM in the metal tip of a Centrix gun and apply on the perforation site.

5.       Pack by using an endo condenser or a paper point.

6.       After setting is complete, remove excess ENDOCEM by using an endodontic file while the access cavity is filled with 5.25% NaOCl.  When doing so, make sure that packed ENDOCEM does not get washed away.

7.       Take a radiograph to confirm placement of ENDOCEM. If the perforated site does not get filled completely, wash it all out by using an endodontic ultrasonic device and other appropriate methods; and perform the repair process again.

8.       Perform endodontic treatment.

 

 

 

Root-end filling

1.       After approaching the apical lesion by forming a flap, resect apical 3 mm with surgical bur.

2.       Form a 3mm deep cavity on the resected apex by using an ultrasonic apico-tip.

3.       If there is bleeding at the site, control by compression methods, i.e. cotton pellet,

etc along with hemostatic agent.

4.       Discolor with methylene blue to check for cracks or accessory canals in the apical region and observe with microscope.

5.       Remove excess moisture on the formed apical cavity.

6.       Bend the end of the metal tip of a Centrix gun up to 3 mm. When doing so, make sure it does not get clogged due to rounded bending.

7.       Mix the ENDOCEM with unopened distilled water. If not available saline may be used.

8.       Place ENDOCEM in the metal tip and apply it on the apical area.

9.       After removing excess moisture with a sterile cotton pellet or small piece of gauze, pack ENDOCEM.  Do this until you get pull-back with an instrument smaller than the size of the cavity.

10.    Apply ENDOCEM incrementally, and pack. Repeat this process.

11.    After setting is complete, rinse thoroughly with saline and check for wash-out. There should be no wash-out whatsoever.

12.    Take a radiograph to confirm placement of ENDOCEM and fill.

 

STORAGE CONDITIONS:

3 year from manufacture date if storage conditions are followed.

 

Manufacturer MARUCHI

2-208, 42-10, taejanggongdan-gil, Wonju-si, Gangwon-do, Korea, 220-962

TEL : +82-33-734-0330 FAX : +82-33-746-2804

 

 

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