Safety and Efficacy of the Apexum Ablator

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Apexum Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Monitoring: Quail CRO, Romania
Data Analysis: Medistat Ltd., Israel
Information provided by:
Apexum Ltd.
ClinicalTrials.gov Identifier:
NCT00762840
First received: September 29, 2008
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

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


Condition Intervention
Periapical Periodontitis
Device: the Apexum Protocol
Procedure: Conventional endodontic procedure

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
Official Title: Clinical Study to Evaluate the Safety and Efficacy of the Apexum Ablator in Subjects With Periapical Lesions Associated With Root Canal Infection

Further study details as provided by Apexum Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Healing at 12-month follow-up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2006
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apexum
the tooth is treated by a standard root canal treatment, supplemented by Apexum Ablator protocol, in which the periapical lesion tissue is minced and removed through the root canal, in a minimally invasive fashion.
Device: the Apexum Protocol
using the apexum kit for minimally invasive removal of periapical lesion tissue.
Procedure: Conventional endodontic procedure
Standard root canal treatment
Active Comparator: Control
the tooth is subject to conventional endodontic procedure alone, (standard root canal treatment)
Procedure: Conventional endodontic procedure
Standard root canal treatment

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) treatment is performed to eliminate these bacteria from the root canal and prevent its recontamination. The periapical lesion is expected to heal in response to this procedure, with new bone replacing the soft tissue of the lesion. The healing of the lesion may last 6-48 months, depending on its size and individual healing rate (Wang et al 2004).

Not all lesions heal accordingly. Those which fail to heal are subjected to either non-surgical re-treatment or to a surgical procedure called "apicoectomy" (Kim & Kratchman 2006). The surgical procedure consists of cutting the gums, accessing the periapical tissue through a hole drilled in the cortical bone, followed by curetting the soft tissue out of its bony crypt. After such surgical procedure, bone healing is much quicker (Kvist & Reit 1999) and even relatively large lesions may heal within 3-6 months. Nevertheless, pain and swelling usually inflict great discomfort causing patients to lose up to 6 working days (Kvist & Reit 2000).

It is common practice to delay the final dental restoration (crown or bridge) for as long as the periapical lesion has not healed. Even though a surgical intervention could significantly reduce the waiting time, it is not commonly applied due to following: (a) Pain, discomfort and loss of working days, (b) High cost (c) Inaccessibility of many root tips, due to anatomical reasons.

Apexum has developed a family of miniature, minimally invasive surgical tools, facilitating highly innovative methods for the treatment of periapical lesions associated with root canal infection. The Apexum Ablator device allows access to the periapical tissues through the root-canal following the commonly accepted root-canal procedures. The inserted tool grinds the periapical lesion, followed by washing out and aspiration of the ground material.

In the present study, the safety and efficacy of the Apexum Ablator will be assessed in patients with periapical lesions associated with root canal infection by using this clinical investigational plan.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762840

Contacts
Contact: Ronen Huber, DMD +972-54-6611677 ronen@apexum.com

Locations
Romania
Titu Maiorescu University Withdrawn
Bucharest, Romania
Cabinet Stomatologic Dr Dan Dragomirescu Recruiting
Timisoara, Romania
Sponsors and Collaborators
Apexum Ltd.
Monitoring: Quail CRO, Romania
Data Analysis: Medistat Ltd., Israel
Investigators
Principal Investigator: Dragos Slavescu, DMD Titu Maiorescu University
Principal Investigator: Dan Dragomirescu, DMD Cabinet Stomatologic Dr Dan Dragomirescu
  More Information

No publications provided

Responsible Party: Idan Tobis, General manager, Apexum Ltd.
ClinicalTrials.gov Identifier: NCT00762840     History of Changes
Other Study ID Numbers: Apexum Trial
Study First Received: September 29, 2008
Last Updated: June 4, 2009
Health Authority: Romania: Ministry of Public Health

Keywords provided by Apexum Ltd.:
Periapical lesions
Apical Periodontitis
endodontic procedure
root canal treatment

Additional relevant MeSH terms:
Periapical Periodontitis
Periodontitis
Periapical Diseases
Jaw Diseases
Stomatognathic Diseases
Periodontal Diseases
Mouth Diseases

ClinicalTrials.gov processed this record on April 21, 2014