Safety and Efficacy of the Apexum Ablator

1. Subject is > 18 years old

2. Subject has periapical lesion(s) associated with root canal infection in one or more roots that have a single root canal per root. These may include upper and lower single rooted incisors, canines or premolars, as well as roots of multi-rooted teeth, providing that they have a single root canal per root. These may include distal roots of lower molars, palatal and disto-buccal roots of upper molars

3. Lesion mean diameter: 3-6 mm, PAI score 4 or 5

4. Roots with mature fully formed apices

1. Previous root canal filling

2. Roots with abnormal root canal morphology

3. Roots with more than one root canal per root, as either evident from the pre-operative radiographs or as discovered during initiation of the root canal treatment

4. A tooth that remained symptomatic after the first and when needed a second session of the root canal treatment (remained with an excessive sensitivity to percussion, persistent sinus tract, persistent exudate in the root canal etc.)

5. Un-restorable teeth

6. Significant periodontal pockets

7. Lack of cortical bone around the lesion, as judged clinically

8. Active acute infection - cellulites, abcess

9. Proximity of anatomical structures to the periapical lesion to the extent that Apexum Ablator enucleation procedure may damage or otherwise jeopardize these structures. Such anatomical structures may include the maxillary sinus, the nasal cavity, the inferior alveolar nerve and its canal, the mental nerve or any other structure that may be jeopardized by the procedure

10. Subject with:

11. Other severe or life-threatening systemic disease (ASA P3 and above)