1. Indication
Direct X Gold SX: flaring of root canal during non-surgical endodontic treatment.
Direct X Gold X1: glide path of root canals during non-surgical endodontic treatment.
Direct X Gold X2, X3, X4: shaping of root canal during non-surgical endodontic treatment.
Use by dental professionals only.
2. Contraindications
Apart from children under 2 years of age (ethylene oxide used in the sterilization process), there is no contraindication to the use of the files for endodontically treating a tooth by orthograde route.
3. Complications
In cases of complex canal anatomy, per-operative risks (instrumental breakage, ledge, stripping, zipping, false path, perforation, etc.) could occur and lead to a risk of infectious processes.
4. Warnings/precautions
• The decision to use an endodontic instrument must be relayed to the clinical case expertise, particularly where the canal anatomy is considered to be too complex.
• Patients identified as having a risk of infectious endocarditis.
• Contains Nickel and Titanium and must not be used on patients with known allergic sensitivity to these metals.
• Respect the good dental practice in particular by using a dental dam and gloves.
• Use in continuous rotation at the recommended speed.
• In cases of complex anatomy, the maximum torque may be different from the value recommended by the manufacturer.
• Use according to the recommended procedure (§7).
• Do not use in retreatment.
• Instruments supplied sterile: Check the integrity of the packaging before use. If damaged, do not use the instruments.
• Respect the expiry date.
• Keep the UDI information which is only on the labelling until the last use.
• Year of manufacture: see labelling.
• Do not use if doubt on the respect of storage conditions.
• In case of doubt concerning the product identification, do not use.
• Check the condition of the instrument before use between each canal. If the instrument is damaged or shows signs of wear, do not use it.
• Single use Instrument: do not reuse the instruments. If you do, there is a risk of decreased performance and security characteristics (e.g.: fracture of the instrument in the tooth).
• Inform the manufacturer and the national regulatory authority of any serious incident relating to the instrument.
5. Clinical claims
Direct X Gold files in normal conditions.
Clinical performance:
• Shaping ability: adapted debris removal and cutting efficiency
• Respect of canal anatomy
• Geometry adapted to irrigation
• Maintains the apical foramen in its original position
Usability:
• Improved flexibility through heat treatment
Safety:
• Limited risk of breakage
• Limited risk of screwing
• Limited risk of shaping aberration
Note: Direct X Gold X1 is glide path file used before shaping operations. Direct X Gold SX is a flaring instrument used at start of the shaping.
6. Characteristics
Type 2 continuous rotating instruments under EN ISO 3630-1: 2019 standard:
• Maximum recommended torque: see table ‘Recommended Torque’. Material of operative part: Nickel-Titanium.
Use in connection with an endodontic contra-angle according to EN ISO 1797: 2017 (Type 1). Number of uses:
• Direct X Gold X1-X2: maximum of 2 canals recommended on the same patient and on the same tooth if the instrument is not visually damaged.
• Direct X Gold SX-X3-X4: maximum of 5 canals recommended on the same patient and on the same tooth if the instrument is not visually damaged. Medical device class according to Directive 93/42 and MDR 2017/745: IIa.
7. Protocol
General information on the protocol for use:
• After opening the access cavity, sodium hypochlorite must be constantly used and renewed before and after each passage of instruments. The sodium hypochlorite must be placed using a syringe in order to be injected as close as possible to the apical region.
Operating procedure:
• Create a straight line access to the root canal entrance. if necessary, use a flaring instrument like SX.
• Consult pre-operative radiographs to determine if canals are Calcified, Narrow, Medium or Large.
• In most cases, they will be Narrow and the X2 should be used to shape the canal.
CANAL PREPARATION & INSTRUMENT GAUGING STEPS
Determine largest hand file passively reaching working length.
1. If a #25 or larger hand file passively reaches working length, the canal is Large. Next use the X4 to shape the canal to working length.
2. If a #20 hand file passively reaches working length, the canal is Medium. Next use the X3 to shape the canal to working length.
3. If a #15 hand file passively reaches working length, the canal is Narrow. Next use the X2 to shape the canal to working length.
4. If only a #10 or smaller hand file reaches working length, the canal is Calcified. Form an initial GlidePath with the #10 hand file. Next use the X1 or #15 hand file to finish the GlidePath. Next use the X2 to shape the canal to working length.
GLIDEPATH FOR CALCIFIED CANALS
If an ISO size #10 hand instrument does not go to working length, flood the canal with 17% liquid EDTA, then work a #6 hand instrument approximately 1mm past the estimated working length. Rinse with 17% liquid EDTA and repeat with a #8 and then a #10 hand instrument, working it approximately 1mm past the estimated working length. Next go back to Canal Preparation Step 4.
Note: It is necessary to irrigate abundantly between each instrument passage and to clean the flutes of the instrument after each introduction into the canal. Check the instrument between each canal.
8. Reprocessing instructions
Not applicable.
9. Storage and transport conditions
Sterile devices, keep away from sunlight and keep dry.