Periapical Periodontitis Clinical Trial
Official title:
Clinical Study to Evaluate the Safety and Efficacy of the Apexum Ablator in Subjects With Periapical Lesions Associated With Root Canal Infection
NCT number | NCT00762840 |
Other study ID # | Apexum Trial |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | September 29, 2008 |
Last updated | June 4, 2009 |
Start date | October 2006 |
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 procedure was supplemented with the Apexum Ablator protocol
Status | Recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Romania | Titu Maiorescu University | Bucharest | |
Romania | Cabinet Stomatologic Dr Dan Dragomirescu | Timisoara |
Lead Sponsor | Collaborator |
---|---|
Apexum Ltd. | Medistat Ltd., Israel, Monitoring: Quail CRO, Romania |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 6 months | No | |
Secondary | Healing at 12-month follow-up. | 12 months | No |
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