Septodont R.T.R Syringe

• Replacement of bone loss following tooth extraction, intrabony defect treatment. Bone grafting material during sinus lift procedures.

• 0.8 cm³ curved syringe in single-unit package sterilized by gamma radiation (minimal dose: 25 kGy).

DESCRIPTION

R.T.R. is made of β tricalcium phosphate granules of synthetic origin.

R.T.R. calcium phosphates are manufactured using the latest technologies, which guarantees that our products will have an extremely high level of purity.

PROPERTIES

R.T.R. is available as granules, with a size ranging between 500 μm and 1 mm.

The size of macropores varies from 100 µm to 400 μm and micropores are less than 10 μm in diameter. These specific structural properties allows the colonization of macropores by newly formed bone.

R.T.R. is gradually resorbable.

INDICATIONS

R.T.R. is designed for the filling and reconstruction of bone defects in maxillofacial and dental surgery.

CONTRAINDICATIONS :

• Acute osteomyelitis or necrosis of the recipient site.
• Bone degeneration.

- Known active infection.

• Known allergy to any constituent of the bone substitute.

WARNINGS AND PRECAUTIONS FOR USE

The manufacturer of R.T.R. guarantees material and manufacture quality. Several criteria are of crucial importance for the operation with R.T.R. to be successful:

• appropriate selection of the patient who will undergo the operation,
• rigorous asepsis.

The practitioner is responsible for any complication which may result from improper use, faulty operative technique or lack of asepsis. These complications cannot be attributed to the manufacturer.

Underlying oral pathologies such as infections should be treated and ruled out before applying R.T.R.

Avoid saliva contamination.

The bone site which will be in contact with R.T.R. should be debrided and, if possible, well vascularised, so as to create a high quality recipient bed.

Any non-used part of R.T.R. should be systematically disposed of since the product is no longer sterile.

Check the packaging integrity before use.

Do not use if packaging has been damaged or opened before first use.

RESTERILISATION AND REUSE

The resterilisation and/or reuse of the R.T.R. bone substitutes is strictly prohibited, as it could expose the patient concerned to contamination and a subsequent risk of infection. Reusing a R.T.R. bone substitute would reduce its efficiency, namely a reduced strength (fracture risk) and a phenomenon of incomplete bone remodelling. There is also a significant risk of inflammatory reaction (for example, a host response against the graft before it has been implanted).

INSTRUCTIONS FOR USE

There are several possible methods of application for R.T.R.

• If using R.T.R Syringe, the granules may be packed directly into the bone cavity before closing the soft tissues.

To do so, take some blood or saline solution through the filter tip of the syringe by pulling the plunger up until all the granules are soaked. The excess liquid can be easily released by pushing the plunger down. Remove the tip and inject the mixture into the surgical site by pushing the plunger down.

The granules can also be mixed with the patientʼs blood or with saline solution in a sterile Dappen dish before being placed onto the operative site using a dental spatula.

• If using R.T.R. Granules, the granules can be mixed with the patientʼs blood or with saline solution in a sterile Dappen dish before being placed onto the operative site using a dental spatula. For large bone

defects, R.T.R. can be mixed with bone particles from the same patient (autologous bone).

In any case, the operative site will have to be closed by joining together the wound edges (coaptation) with suture stitches.

EXPECTED PERFORMANCE

As their chemical composition is very close to that of natural mineral bone, calcium phosphates – and particularly β-tricalcium phosphate – play an important role in the biological processes governing the stability and regeneration of bone tissue. Accordingly, the role of R.T.R. bone substitutes is to temporarily replace bone tissue in the event of major tissue deficiency caused by trauma or a physiological problem. Thus these devices enable initiation of the bone remodelling phenomenon whilst facilitating their replacement with newly formed natural bone.

STORAGE

Keep only in the original container.

EXPIRY DATE

Do not use after the expiry date mentioned on the outer package.

PRESENTATION

• 0.8 cm3 curved syringe in single-unit package sterilised by gamma

radiation (minimal dose: 25 kGy).

2 cm3 bottle in single-unit package sterilised by gamma radiation (minimal dose: 25 kGy). For professional dental use only