Status:
UNKNOWN
Safety and Efficacy of the Apexum Ablator
Lead Sponsor:
Apexum Ltd.
Collaborating Sponsors:
Monitoring: Quail CRO, Romania
Medistat Ltd., Israel
Conditions:
Periapical Periodontitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is designed to test the hypothesis that there is a difference in healing kinetics and healing rate between teeth treated by conventional endodontic procedure alone and those in which such pr...
Detailed Description
Periapical lesions consist of inflammatory tissue replacing the bone surrounding the root-tip (apex) and are caused by bacteria present in an infected root canal (Metzger 2000). Endodontic (root canal...
Eligibility Criteria
Inclusion
- Subject is \> 18 years old
- 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
- Lesion mean diameter: 3-6 mm, PAI score 4 or 5
- Roots with mature fully formed apices
Exclusion
- Previous root canal filling
- Roots with abnormal root canal morphology
- 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
- 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.)
- Un-restorable teeth
- Significant periodontal pockets
- Lack of cortical bone around the lesion, as judged clinically
- Active acute infection - cellulites, abcess
- 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
- 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 \[sub acute bacterial endocarditis (SBE\]
- Other severe or life-threatening systemic disease (ASA P3 and above)
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00762840
Start Date
October 1 2006
Last Update
June 5 2009
Active Locations (2)
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1
Titu Maiorescu University
Bucharest, Romania
2
Cabinet Stomatologic Dr Dan Dragomirescu
Timișoara, Romania