Cobalt Caries Detector Dye- IFU

Product Description:

Cobalt Caries Detector Dye is a diagnostic aid available in pink and green to detect carious dentin. This dye solution selectively stains demineralized collagen fibers in carious dentin, allowing differentiation between the outer carious dentin (infected dentin), which is irreversibly damaged, and the inner carious dentin (affected dentin), which may still be capable of demineralization. Cobalt Caries Detector Dye provides a reliable guide for minimally invasive caries removal, helping clinicians preserve sound dentin with the potential for demineralization. Cobalt Caries Detector Dye supports conservative dentistry principles by facilitating precise, targeted caries excavation.

Components:

6 cc bottle of Caries Detector Dye.

Indications:

  • Verification of Complete Caries Removal: Ensures all infected dentin is removed while preserving healthy, remineralizable dentin.
  • Detection of Residual Caries: Identifies remaining carious tissue, particularly in hard-to-reach areas like under cusps and within peripheral seal zones.
  • Differentiation of Dentin Types: Distinguish between healthy and infected dentin, especially when secondary dentin has formed.
  • Endodontic Assistance: Aids in locating canal orifices within the pulp chamber during root canal treatments.
  • Crack Detection: Helps identify small cracks within the tooth structure that may be clinically significant.
  • Patient Education: Visually highlights carious regions to help patients understand their dental conditions.
  • Professional Training: Serves as a teaching tool to demonstrate caries progression and removal techniques on extracted teeth.

Instructions for Use:

  1. Protect the patient: Cover the patient’s face and eyes with a drape or towel.
  2. Isolate the tooth: Use a rubber dam to isolate the decayed tooth, ensuring a dry working field.
  3. Initial excavation: Remove the softened, infected outer dentin and thoroughly rinse the cavity with water. Dry the area using air.
  4. Dye application: Apply one drop of Cobalt Caries Detector Dye to the cavity using a microbrush. Wait for 10 seconds to allow the dye to interact with the demineralized dentin.
  5. Rinse and dry: Thoroughly rinse the tooth with water and dry using air.
  6. Evaluate staining: The stained areas represent infected carious dentin. Carefully remove the stained dentin using a round bur or excavator.
  7. Repeat as needed: Reapply the dye and continue excavation until no further stained dentin is visible, indicating that caries removal is complete. The unaffected dentin will remain unstained.

Clinical Considerations:

  • When using caries detector dyes, it is essential to keep the solution on the tooth surface for no longer than 10 seconds to prevent overstaining, which can complicate the assessment of caries.
  • There is also a risk of false positives in areas with hypomineralized dentin, especially near the dentino-enamel junction or close to the pulp. Clinicians should use tactile feedback, radiographic analysis, and their clinical judgment in conjunction with the dye findings to make accurate decisions.
  • Properly isolating the tooth is critical to avoid staining surrounding soft tissues and non-target areas, which could lead to misinterpretations.
  • Additionally, caution is required when applying the pink solution near the pulp, as it may resemble the colour of the pulp tissue, increasing the risk of over-excavation if not carefully monitored.

Additional Use Cases:

  • Plaque staining: Plaque present on the tooth surface may be stained by the dye. Plaque should be thoroughly removed before using the dye.
  • Cleaning stained areas: If unintended areas are stained, they can be cleaned with solutions like sodium hypochlorite, white vinegar, or hydrogen peroxide.

Warnings:

  • Protective measures: Always wear gloves during application to prevent allergic reactions or skin irritation. Avoid direct contact with eyes or skin. If contact occurs, rinse with plenty amounts of water.
  • Eye safety: If the product splashes into the eyes, irrigate with water for 15 minutes and seek medical attention.
  • Patient safety: Prevent the patient from swallowing the product during application.

Storage Conditions:

  • Store the product between 5°C and 25°C. Refrigeration is acceptable in warmer climates, but allow the product to reach room temperature before use.
  • Keep the product away from direct sunlight.
  • Do not use the product after its expiration date.

Manufactured by Fartak Andisheh Borna Company, Tehran, Iran, at the Dental Material and Equipment Development Center, Tehran University of Medical Sciences, Innovation Park, 1st Floor.

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