Back to results

Safety and Efficacy of the Apexum Ablator

Primary Purpose

Periapical Periodontitis

Status

Unknown status

Phase

Not Applicable

Locations

Romania

Study Type

Interventional

Intervention

the Apexum Protocol

Conventional endodontic procedure

About this trial

This is an interventional treatment trial for Periapical Periodontitis focused on measuring Periapical lesions, Apical Periodontitis, endodontic procedure, root canal treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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)

Sites / Locations

Titu Maiorescu University
Cabinet Stomatologic Dr Dan DragomirescuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apexum

Control

Arm Description

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.

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

Outcomes

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

Secondary Outcome Measures

Healing at 12-month follow-up.

Full Information

NCT ID

NCT00762840

First Posted

September 29, 2008

Last Updated

June 4, 2009

Sponsor

Apexum Ltd.

Collaborators

Monitoring: Quail CRO, Romania, Medistat Ltd., Israel

1. Study Identification

Unique Protocol Identification Number

NCT00762840

Brief Title

Safety and Efficacy of the Apexum Ablator

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2006 (undefined)

Primary Completion Date

April 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Apexum Ltd.

Collaborators

Monitoring: Quail CRO, Romania, Medistat Ltd., Israel

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periapical Periodontitis

Keywords

Periapical lesions, Apical Periodontitis, endodontic procedure, root canal treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apexum

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

the Apexum Protocol

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Conventional endodontic procedure

Intervention Description

Standard root canal treatment

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Healing at 12-month follow-up.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ronen Huber, DMD

Phone

+972-54-6611677

ronen@apexum.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dragos Slavescu, DMD

Organizational Affiliation

Titu Maiorescu University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dan Dragomirescu, DMD

Organizational Affiliation

Cabinet Stomatologic Dr Dan Dragomirescu

Official's Role

Principal Investigator

Facility Information:

Facility Name

Titu Maiorescu University

City

Bucharest

Country

Romania

Individual Site Status

Withdrawn

Facility Name

Cabinet Stomatologic Dr Dan Dragomirescu

City

Timisoara

Country

Romania

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of the Apexum Ablator

We'll reach out to this number within 24 hrs