Safety and Efficacy of the Apexum Ablator

NCT ID: NCT00762840

Last Updated: 2009-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

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 procedure was supplemented with the Apexum Ablator protocol

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.

Conditions

Periapical Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

the Apexum Protocol

Intervention Type: DEVICE

using the apexum kit for minimally invasive removal of periapical lesion tissue.

Conventional endodontic procedure

Intervention Type: PROCEDURE

Standard root canal treatment

Control

the tooth is subject to conventional endodontic procedure alone, (standard root canal treatment)

Group Type: ACTIVE_COMPARATOR

Conventional endodontic procedure

Intervention Type: PROCEDURE

Standard root canal treatment

Interventions

the Apexum Protocol

using the apexum kit for minimally invasive removal of periapical lesion tissue.

Intervention Type: DEVICE

Conventional endodontic procedure

Standard root canal treatment

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Monitoring: Quail CRO, Romania

UNKNOWN

Sponsor Role: collaborator

Medistat Ltd., Israel

INDUSTRY

Sponsor Role: collaborator

Apexum Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Apexum Ltd.

Principal Investigators

Dragos Slavescu, DMD

Role: PRINCIPAL_INVESTIGATOR

Titu Maiorescu University

Dan Dragomirescu, DMD

Role: PRINCIPAL_INVESTIGATOR

Cabinet Stomatologic Dr Dan Dragomirescu

Locations

Titu Maiorescu University

Bucharest, , Romania

Site Status: WITHDRAWN

Cabinet Stomatologic Dr Dan Dragomirescu

Timișoara, , Romania

Site Status: RECRUITING

Countries

Romania

Central Contacts

Ronen Huber, DMD

Role: CONTACT

ronen@apexum.com

+972-54-6611677

Other Identifiers

Apexum Trial

Identifier Type: -

Identifier Source: org_study_id