NCT00762840

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

June 5, 2009

Status Verified

June 1, 2009

Enrollment Period

3.5 years

First QC Date

September 29, 2008

Last Update Submit

June 4, 2009

Conditions

Periapical Periodontitis

Keywords

Periapical lesionsApical Periodontitisendodontic procedureroot canal treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Healing at 12-month follow-up.

    12 months

Study Arms (2)

Apexum

EXPERIMENTAL

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 ProtocolProcedure: Conventional endodontic procedure

Control

ACTIVE COMPARATOR

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

Procedure: Conventional endodontic procedure

Interventions

the Apexum ProtocolDEVICE

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

Apexum
Conventional endodontic procedurePROCEDURE

Standard root canal treatment

ApexumControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Titu Maiorescu University

Bucharest, Romania

WITHDRAWN

Cabinet Stomatologic Dr Dan Dragomirescu

Timișoara, Romania

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Officials

  • Dragos Slavescu, DMD

    Titu Maiorescu University

    PRINCIPAL INVESTIGATOR

  • Dan Dragomirescu, DMD

    Cabinet Stomatologic Dr Dan Dragomirescu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronen Huber, DMD

CONTACT

+972-54-6611677ronen@apexum.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 29, 2008

First Posted

September 30, 2008

Study Start

October 1, 2006

Primary Completion

April 1, 2010

Last Updated

June 5, 2009

Record last verified: 2009-06

Locations

RO(2)