Safety and Efficacy of the Apexum Ablator

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00762840
• Date of registration: 29/09/2008
• Prospective Registration: No
• Primary sponsor: Apexum Ltd.
• Public title: Safety and Efficacy of the Apexum Ablator
• Scientific title: Clinical Study to Evaluate the Safety and Efficacy of the Apexum Ablator in Subjects With Periapical Lesions Associated With Root Canal Infection
• Date of first enrolment: October 2006
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00762840
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Romania

Contacts

• Name: Dragos Slavescu, DMD
• Affiliation: Titu Maiorescu University

• Name: Ronen Huber, DMD

• Name: Dan Dragomirescu, DMD
• Affiliation: Cabinet Stomatologic Dr Dan Dragomirescu

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

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:

- Uncontrolled systemic hypertension

- Severe uncontrolled Diabetes Mellitus

- Current steroid therapy in excess of prednisone 5 mg/day

- Chronic inflammatory oral disease

- HIV positive patients

- Chronic renal failure

- Hematological disease (malignancy, severe anemia, bleeding tendency etc.)

- Osteoporosis, receiving biphosphonates

- Post head and neck irradiation treatment

- In need of endocarditis antibiotic prophylactic treatment [sub acute bacterial
endocarditis (SBE]

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Periapical Periodontitis

Intervention(s)

Procedure: Conventional endodontic procedure

Device: the Apexum Protocol

Primary Outcome(s)

Healing at 6-month follow-up, defined dichotomously by whether lesion is in the process of Healing or not, indicated by whether PAI score at 6 months is at 3 or below [Time Frame: 6 months]

Secondary Outcome(s)

Healing at 12-month follow-up. [Time Frame: 12 months]

Secondary ID(s)

Apexum Trial

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Monitoring: Quail CRO, Romania

Data Analysis: Medistat Ltd., Israel