Biodentine – bioactive dentin substitute

biodentine
Biodentine is a bioactive dentin substitute from the « Active Biosilicate Technology » innovation.

Tricalcium silicate powder

Aqueous calcium chloride solution and excipients

  1. Biodentine has mechanical properties similar to the sound dentin and can replace it both in the crown
    and in the root, without any preliminary conditioning of mineral tissues
  2. Material contains high-purity, monomer-free mineral ingredients and is highly biocompatible.
  3. Biodentine creates the optimal conditions for maintenance of pulp vitality, by providing a very tight seal
    on the dentin surface. It therefore reduces the risk of postoperative sensitivity and the longevity of restorations in vital teeth.
  4. Biodentine, being bioactive, stimulates the pulp cells to build reactionary dentin. The dentin bridges are created faster and are thicker than with similar dental materials and represent the necessary condition for optimal pulp healing.

Offers an initial setting time reduced down to 12 minutes from start of mix, for optimal use in the crown.

Indications

In the crown:

  • Permanent dentin restoration under composites or Inlay/Onlay
  • Temporary dentin-enamel restoration.
  • Restoration of deep and/or large coronal carious lesions (sandwich technique).
  • Restoration of cervical radicular lesions.
  • Pulp capping.
  • Pulpotomy.

In the root:

  • Repair of root perforations.
  • Repair of furcation perforations.
  • Repair of perforating internal resorptions.
  • Repair of external resorption
  • Apexification.
  • Root-end filling in endodontic surgery (retrograde filling).

Is not to be used for permanent obturation or sealing of the root canal

Contraindication
Allergy to one of the ingredients.

Limits of use
– Restoration of large loss of tooth substance subjected to high stresses.
– Esthetic restoration of anterior teeth.
– Treatment of teeth with irreversible pulpitis.

Side effects
– No known side effects.

Biodentine – Instructions for use  (For each indication)

Biodentine mixing instructions

  1. Take a capsule and gently tap it on a hard surface to loosen the powder.
  2. Open a capsule and place it on the white capsule holder.
  3. Detach a single-dose container of liquid and gently tap on the sealed cap to force all the liquid down the container.
  4. Twist cap to open. Be careful that no drop of liquid falls out of the single dose container.
  5. Pour 5 drops from the single-dose container into the capsule.
  6. Close the capsule. Place the capsule on a mixing device, such as Technomix, Tac 400 (Lineatac), Silamat, Cap-Mix, Rotomix, Ultramat etc., at a speed of 4000 – 4200 rotations/min.
  7. Mix for 30 seconds.
  8. Open the capsule and check the materialʼs consistency. If a thicker consistency is preferred, wait for 30 sec to 1 min before checking again. Do not exceed the working time.
  9. Collect Biodentine with the instrument supplied in the box. Depending on the desired application, you may handle Biodentine with an amalgam carrier, a spatula or a Root Canal Messing Gun. Rapidly rinse and clean the instruments to remove any residual material.

Immediate enamel restoration:
Assess pulp vitality by the usual tests: is not indicated for the treatment of teeth with irreversible
pulpitis.

  1. Isolate the tooth with a rubber dam.
  2. Remove the infected dentin with a round bur and/or a hand excavator. Leave the affected dentin.
  3. Adapt a matrix around the tooth if a wall is missing.
  4. Prepare Biodentine as indicated above (mixing instructions)
  5. Insert Biodentine in the cavity, so that the volume of missing dentin is replaced by the same volume of Biodentine avoiding to trap air bubbles. Flatten the material without excessive pressure and ensure good adaptation to the cavity walls and margins.
  6. Wait until the end of the setting time (12 minutes) before performing the permanent enamel restoration. Biodentine is compatible with all direct crown restoration techniques and particularly with all types of bonding systems.

Non-Immediate enamel restoration
Assess pulp vitality by the usual tests: is not indicated for the treatment of teeth with irreversible
pulpitis.

  1. Isolate the tooth with a rubber dam.
  2. Remove the infected dentin with a round bur and/or a hand excavator. Leave the affected dentin.
  3. Adapt a matrix around the tooth if a wall is missing.
  4. Prepare Biodentine as indicated above (mixing instructions)
  5. Insert Biodentine in the cavity avoiding trapping air bubbles. Ensure good adaptation of the material to the cavity walls and margins. Do not apply excessive pressure on the material.
  6. Model the surface of the restoration
  7. Wait until the end of the setting time (12 minutes) before removing the matrix
  8. To optimize the mechanical properties of the material and facilitate removal of the matrix, a varnish can be applied onto the surface of the restoration.
  9. Check occlusion.
  10. Within one week to six months after placement of Biodentine, prepare the cavity according to the criteria recommended for the selected restorative material. The remaining Biodentine material can be considered as sound artificial dentin and permanently left in deep areas of the cavity and in areas adjacent to the pulp chamber. Biodentine is compatible with all direct or indirect crown restoration techniques (Inlay/Onlay), and particularly with all types of bonding systems.

Pulp capping:
Assess pulp vitality by the usual tests: Biodentine is not indicated for the treatment of teeth with irreversible
pulpitis

  1. Isolate the tooth with a rubber dam.
  2. Remove the infected dentin with a round bur and/or a hand excavator. Leave the affected dentin.
  3. Adapt a matrix around the tooth if a wall is missing.
  4. If there is bleeding in the pulp, hemostasis must be achieved before applying Biodentine.
  5. Prepare Biodentine as indicated above (mixing instructions).
  6. Place Biodentine directly on the exposed pulp avoiding trapping air bubbles. Ensure good adaptation of the material to the cavity walls and margins. Do not apply excessive pressure on the material.
  7. Perform the immediate or non-immediate enamel restoration as indicated above.

Pulpotomy:

  1. Isolate the tooth with a rubber dam.
  2. Remove the infected dentin with a round bur and/or a hand excavator.
  3. Gain access to the pulp chamber and clean out the pulp.
  4. If there is bleeding in the pulp, hemostasis must be achieved before applying Biodentine.
  5. Adapt a matrix around the tooth if a wall is missing.
  6. Prepare Biodentine as indicated above (mixing instructions).
  7. Place Biodentine directly in the pulp chamber and ensure good adaptation to the cavity walls and margins.
  8. Model the surface of the restoration.
  9. Wait until the end of the setting time (12 minutes) of the material before removing the matrix.
  10. To optimize the mechanical properties of the material and facilitate removal of the matrix, a varnish can be applied onto the surface of the restoration.
  11. Check occlusion.
  12. Within one week to six months after placement of Biodentine, prepare the cavity according to the criteria recommended for the selected restorative material. The remaining material can be considered as sound artificial dentin and permanently left in deep areas of the cavity and in areas adjacent to the pulp chamber. Biodentine is compatible with all direct or indirect crown restoration techniques, and particularly with all types of bonding systems.

Repair of root perforations:

  1. Isolate the tooth with a rubber dam.
  2. Prepare the root canal alternately using suitable endodontic instruments and a solution of sodium hypochlorite.
  3. Dry the canal with paper points and use a chlorhexidine solution or a calcium hydroxide paste for disinfection between visits. Tightly seal the access cavity with a temporary cement to protect the temporary filling.
  4. At the next visit (usually after one week), place a rubber dam and remove the temporary crown restoration. Clean the canal alternately using a solution of sodium hypochlorite and suitable endodontic instruments. Dry the canal with paper points.
  5. Prepare Biodentine as indicated above (mixing instructions).
  6. Dispense Biodentine over the perforation site using a suitable instrument.
  7. Condense Biodentine with a plugger.
  8. Take an X-ray to check that the material is correctly positioned.
  9. Remove excess material and place a temporary filling.
  10. Complete root canal treatment at the next visit according to current recommendations.

Repair of furcation perforations:

  1. Isolate the tooth with a rubber dam.
  2. Rinse the cavity with a solution of sodium hypochlorite to disinfect the area.
  3. If there is bleeding, hemostasis must be achieved before applying Biodentine.
  4. Dry the pulp chamber.
  5. Prepare Biodentine as indicated above (mixing instructions).
  6. Dispense Biodentine and condense. Perforation repair and crown restoration are performed in a single step.
  7. Take an X-ray to check that the material is correctly positioned.
  8. Remove excess material.
  9. At a subsequent visit, if all clinical signs of a successful treatment are present, the possibility of a permanent restoration can be considered.

Repair of perforating internal resorptions:

  1. Isolate the tooth with a rubber dam.
  2. Prepare the root canal alternately using suitable endodontic instruments and a solution of sodium hypochlorite.
  3. Dry the canal with paper points and use a calcium hydroxide paste for disinfection between visits. Tightly seal the access cavity with a temporary cement to protect the temporary filling.
  4. At the next visit (usually after one week), place a rubber dam and remove the temporary crown restoration. Clean the canal alternately using a solution of sodium hypochlorite and suitable endodontic instruments. Dry the canal with paper points.
  5. Prepare Biodentine as indicated above (mixing instructions).
  6. Dispense Biodentine over the resorptive defect using a suitable instrument.
  7. Condense Biodentine with a plugger.
  8. Take an X-ray to check that the material is correctly positioned.
  9. Remove excess material and place a temporary filling.
  10. Complete root canal treatment at the next visit according to current recommendations.

Apexification:

  1. Isolate the tooth with a rubber dam.
  2. Prepare the root canal alternately using suitable endodontic instruments and a solution of sodium hypochlorite.
  3. Dry the canal with paper points and use a calcium hydroxide paste for disinfection between visits. Tightly seal the access cavity with a temporary cement to protect the temporary filling.
  4. At the next visit (usually after one week), place a rubber dam and remove the temporary crown restoration. Clean the canal alternately using a solution of sodium hypochlorite and suitable endodontic instruments. Dry the canal with paper points.
  5. Prepare Biodentine as indicated above (mixing instructions).
  6. Dispense Biodentine in the root canal using a suitable instrument.
  7. Condense Biodentine with a plugger.
  8. Take an X-ray to check that the material is correctly positioned.
  9. Remove excess material and place a temporary filling.
  10. Complete root canal treatment at the next visit according to current recommendations.

Root-end filling in endodontic surgery:

  1. Gain access to the operative site following the current recommendations in endodontic surgery.
  2. Using a specific ultrasonic tip, prepare a root-end cavity, 3 to 5 mm deep in the apical portion of the root canal.
  3. Isolate the area. Achieve hemostasis. Dry the cavity with paper points.
  4. Prepare Biodentine as indicated above (mixing instructions).
  5. Dispense Biodentine in the cavity using a suitable instrument. Condense Biodentine with a small plugger.
  6. Remove excess material and clean the surface of the root.
  7. Take an X-ray to check that the material is correctly positioned.

Warnings and precautions for use

  • Ensure that the rubber dam is properly placed so as to completely isolate the operating field.
  • Water contamination slows the setting of the material. Prevent exposure to water and fluids during the initial setting stage, i.e.12 minutes.
  • Single-use product: this product is designed to be used for one single patient. Reusing it would create a risk of contamination.

Storage
– Store in a dry place.

Presentation
– Box containing 15 capsules and 15 single-dose containers.

For professional dental use.

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