Dentsply Sirona 221325 Root Canal Sealer Instruction Manual

Dentsply Sirona 221325 Root Canal Sealer

Product Information

• Product Name: Root Canal Sealer
• Description: The Root Canal Sealer is a dental product made of Bisphenol-A epoxy resin.
• Usage: The sealer is used for filling and sealing root canals during dental procedures.
• Caution: This product is intended for dental use only and is classified as a prescription-only product in the USA.

Product Usage Instructions

Step 1: Preparation
Prior to applying the sealer, prepare, clean, and dry the root canals using advanced endodontic techniques.

Step 2: Dosage and Mixing

1. Ensure that the paste condition is appropriate. Slight separation may occur in Paste B, but it does not affect the setting time of the mixed product. If the dispensed material is clear, discard it to ensure convenient handling of the mixed paste.
2. Tightly close the tubes after use and do not exchange caps between tubes. The white cap belongs to paste A, while the grey cap belongs to paste B.
3. Bleed the syringe prior to the first use to ensure appropriate mixing ratios. The filling volumes of pastes A (amber color) and B (white color) may vary slightly.
4. Carefully apply steady pressure onto the plunger to automatically mix the two pastes.

Step 3: Application

1. To prevent overfilling of the root canal, do not place too much sealer.
2. If using condensation or warm gutta-percha obturation techniques, apply only a light coating of sealer onto the canal walls.
3. If overfilling occurs, the material is usually tolerated well by the surrounding tissue. However, if the material is pressed into the mandibular canal, apply immediate care measures.
4. To avoid clogging and separation of the mixing tip from the syringe, do not allow the material to dry inside. Always ensure that the mixing tip is properly connected to the syringe before application.

Step 4: Removal of Root Canal Filling

1. If the root canal filling needs to be removed, it is recommended to use thermo-mechanical techniques when the sealer is used in combination with (gutta-percha) points.

Step 5: Hygiene

1. The syringe cannot be reprocessed, so dispose of it according to local regulations.
2. To prevent contamination, handle the syringe with clean/disinfected gloves and avoid exposure to spatter or spray of body fluids or contaminated hands. Do not reuse a contaminated syringe.

Note:
For more detailed safety notes and information, please refer to the respective sections in the complete user manual.

Product Description

AH Plus® root canal sealer and AH Plus Jet® root canal sealer are based on epoxy amine resin, offering the following features:

• Long-term sealing properties.
• Outstanding dimensional stability.
• Self-adhesive properties.
• Very high radiopacity.

Indications
Permanent obturation of root canals of teeth of the secondary dentition in combination with root canal points.

Contraindications
Use with patients who have a history of severe allergic reaction to epoxy resins or amines or any of the other components.

Delivery forms

• AH Plus® in tubes for manual mixing of paste A and paste B.
• AH Plus Jet® mixing syringe offering a more precise, convenient and faster procedure.

Composition

Paste A (amber color)

• Bisphenol-A epoxy resin
• Bisphenol-F epoxy resin
• Calcium tungstate
• Zirconium oxide
• Silica
• Iron oxide pigments

Paste B (white color)

• Dibenzyldiamine
• Aminoadamantane
• Tricyclodecane-diamine
• Calcium tungstate
• Zirconium oxide
• Silica
• Silicone oil

Bisphenol-A epoxy resin.
The Bisphenol-A epoxy resin contained in AH Plus® is according to IU-PAC nomenclature 2,2’-[(1-methyl ethylidene)bis(4,1-phenyleneoxymeth-ylene)]bis- oxirane (CAS No. 1675-54-3) and must not be taken for the Bisphenol-A (BPA) present in many consumer and some dental products and what has raised concerns about possible adverse health effects.

Safety notes

Be aware of the following general safety notes and the special safety notes in other chapters of these Instructions for Use.

Safety alert symbol

• This is the safety alert symbol. It is used to alert you to potential personal injury hazards.
• Obey all safety messages that follow this symbol to avoid possible injury.

Warnings
The material contains epoxy resins and amines which may be irritating to skin, eyes and oral mucosa and may cause allergic contact dermatitis in susceptible persons.

• Avoid eye contact to prevent irritation and possible corneal damage. In case of contact with eyes rinse immediately with plenty of water and seek medical attention.
• Avoid skin contact to prevent irritation and possible allergic response. In case of contact, reddish rashes may be seen on the skin. If contact with skin occurs, remove material with cotton and alcohol and wash thoroughly with soap and water. In case of skin sensitization or rash, discontinue use and seek medical attention.
• Avoid contact with oral soft tissues/mucosa to prevent inflammation. If accidental contact occurs, remove material from the tissues. Flush mucosa with plenty of water and expectorate/evacuate the water. If inflammation of mucosa persists, seek medi-cal attention.
• Prevent ingestion. If accidental swallowing occurs, have patient drink plenty of wa-ter. If nausea or illness develops, seek medical attention.
• Do not place too much sealer to prevent overfilling of the root canal and damage of periapical tissue.

Precautions
This product is intended to be used only as specifically outlined in these Instructions for Use.

Any use of this product inconsistent with these Instructions for Use is at the discretion and sole responsibility of the dental practitioner.

• Use protective measures for the dental team and patients such as glasses and rub-ber dam in accordance with local best practice.
• Contact with saliva, blood and sulcus fluid during application may cause failure of the root canal filling. Use adequate isolation such as rubber dam.
• The syringes cannot be reprocessed. To prevent the syringes from exposure to spat-ter or spray of body fluids or contaminated hands it is mandatory that the syringes are handled with clean/disinfected gloves. Discard syringes if contaminated.
• As additional precautionary measure, the syringe may be protected from gross con-tamination but not from all contamination by applying the single use Disposa-Shield® protective barrier 1.
• AH Plus Jet® root canal sealer mixing tips and Disposa-Shield® protective barrier are intended for single use only. Discard after use. Do not reuse in other patients in order to prevent cross-contamination or malfunction.
• Interactions:
  • If refrigerated, allow material to reach room temperature prior to use.

Adverse reactions

• Eye contact: Irritation and possible corneal damage.
• Skin contact: Irritation or possible allergic response. Reddish rashes may be seen on the skin.
• Contact with mucous membranes: Inflammation (see Warnings).

Storage conditions
Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.

• Store at temperatures from 10 °C to 24 °C (50 °F-75 °F). Use the product at room temperature.
• Do not use after expiration date.

Step-by-step instructions

Preparation

1. Prior to the application of the material prepare, clean, and dry the root canals to be filled using state-of-the-art endodontic techniques.

Dosage and mixing

AH Plus® root canal sealer (tubes)

Appropriate paste condition.
For Paste B slight separation may occur. This condition does not nega-tively affect the setting time of the mixed product. If the dispensed mate-rial is solely of clear color, discard the dispensed material, to ensure convenient handling of the mixed paste.

1. Using a metal spatula 2, mix equal volume units (1:1) of paste A (amber color) and paste B (white color) of AH Plus® root canal sealer on a glass slab or the mixing pad supplied with the package. Mix to a homogeneous consistency.
2. Tightly close tubes after use.
3. Do not exchange caps of tubes. The white cap belongs to paste A; the grey cap belongs to paste B.

AH Plus Jet® root canal sealer (mixing syringe)

Appropriate mixing ratios.
The syringe filling volumes of pastes A (amber color) and B (white color) vary slightly. To ensure appropriate mixing, bleed the syringe prior to the first use.

The syringe cannot be reprocessed. To prevent the syringe from exposure to spatter or spray of body fluids or contaminated hands it is mandatory that the syringe is handled with clean/disinfected gloves.

1. Remove the cap by turning it 90° counter-clockwise and pulling it.
2. Attach the mixing tip 3 to the syringe, aligning the notch.
3. Turn the tip 90° clockwise and secure the mixing tip in place.
4. Rotate and adjust the tip in angle in order to meet treatment requirements.
5. Use Disposa-Shield® protective barrier when cross-contamination can not be avoided.
6. Carefully apply steady pressure onto the plunger. The two pastes are automatically mixed in equal volume units.
7. After having finished remove the mixing tip by turning it 90° counter-clockwise and pulling it off (together with a protective barrier if any).
8. Replace the cap on the syringe head, align the notch, then turn it 90° clockwise.

Application

Overfilling
Damage of periapical tissue.

1. Do not place too much sealer to prevent overfilling of the root canal. For condensation and warm gutta-percha obturation techniques ap-ply only a light coating of sealer onto the canal walls.
2. If overfilling occurs the material is usually tolerated very well by the surrounding tissue. If however material is pressed into the mandibular canal, immediately apply state of care measures.

Clogging
Separation of mixing tip from the syringe.

1. Do not allow the material to dry inside.
2. Do not reuse the mixing tip.
3. Always make sure the mixing tip is properly connected to syringe before application. The material should extrude easily.

Condensation and warm gutta-percha techniques

1. As a standard technique, the material is used in combination with gutta-percha or other root canal points.
2. For these filling techniques where most of the canal is obturated by endodontic point material, apply a light coating of sealer with a paper point or file onto the canal walls to the working length and/or apply a light coating of sealer onto the surface(s) of the root canal filling point(s).
3. Insert root canal filling point(s) into the canal according to standard procedure.

Master-Point-Technique

1. Select a gutta-percha point (or alternatively a paper point or a reamer) of the size of the last instrument used during apical preparation.
2. Wet the canal walls with the material through a pumping or simultaneously rotating movement in a counter-clockwise direction of the point/reamer. Alternatively, apply the material onto the tip of a Lentulo spiral.
3. Advance the Lentulo spiral slowly to the apex running at very low speed. Avoid the formation of air bubbles in the material and overfilling of the canal.
4. Withdraw Lentulo very slowly still running at low speed.
5. Dip disinfected and dry master point into the material and insert it into the canal with a slow pumping motion.

Working and setting time

• Working time is 4 hours at 23 °C 4.
• Setting time is 24 hours at 37 °C 5.

Removal of root canal filling

1. If the material is used in combination with (gutta-percha) points, root canal fillings can best be removed using thermo-mechanical techniques.

Hygiene

AH Plus Jet® syringe

Cross-contamination

Infection:

1. The syringe cannot be reprocessed.
2. To prevent the syringe from exposure to spatter or spray of body fluids or contaminated hands it is mandatory that the syringe is handled with clean/disinfected gloves. Do not reuse syringe if contaminated.
3. Dispose of contaminated syringes in accordance with local regulations.

AH Plus Jet® mixing tips and Disposa-Shield® protective barrier
The use of protective barriers is an additional precautionary measure against gross contamination but not against all contamination.

1. Right after use, carefully remove protective barrier together with mixing tip without contaminating the device.

Cross-contamination

Infection

1. Disposa-Shield® protective barrier and AH Plus Jet® root canal sealer mixing tips are intended for single use only. Do not reuse in order to prevent cross-contamination or malfunction.
2. Discard in accdordance with local regulations.

Cleaning

1. Clean spatulas, mixing slabs and instruments immediately after use with alcohol or acetone.

Lot number and expiration date

Lot number ( ) and expiration date (  )

1. Do not use after expiration date.
   ISO standard is used: “YYYY-MM” or “YYYY-MM-DD”.

2. The following numbers should be quoted in all correspondence:

   • Reorder number
   • Lot number
   • Expiration date

© Dentsply Sirona 2017-11-17
[These Instructions for Use are based on Master Version 08]

Manufactured by

Dentsply DeTrey GmbH
De-Trey-Str. 1 78467 Konstanz GERMANY
www.dentsplysirona.com.

Distributed in U.S.A. by
Dentsply Maillefer

Dentsply International, Inc.
608 Rolling Hills Dr. Johnson City, TN 37604
Phone: 1-800-924-7393
Fax: 1-800-924-7389

References

• Dentsply Sirona USA: Dental products and technologies USA

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