Periapical PeriodontitisNCT00762840
Safety and Efficacy of the Apexum Ablator
A study testing the Apexum Protocol and Conventional endodontic procedure in people with Periapical Periodontitis, run by Apexum Ltd. at 2 sites in Romania.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- the Apexum Protocol and Conventional endodontic procedure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesRomania
- Study dates
- Oct 2006to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Romania2 sites, 1 recruiting
- Withdrawn
Titu Maiorescu University
Bucharest
- Recruiting
Cabinet Stomatologic Dr Dan Dragomirescu
Timișoara
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy of the Apexum Ablator in Subjects With Periapical Lesions Associated With Root Canal Infection
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
Read the 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
- Being tested
- the Apexum Protocol, Conventional endodontic procedure
- Keywords
- Periapical lesions, Apical Periodontitis, endodontic procedure, root canal treatment
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Apexum ProtocolDevice
using the apexum kit for minimally invasive removal of periapical lesion tissue.
Conventional endodontic procedureProcedure or surgery
Standard root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: the Apexum Protocol; Procedure: Conventional endodontic procedure |
| Control | Active comparator | the tooth is subject to conventional endodontic procedure alone, (standard root canal treatment) Receives: Procedure: Conventional endodontic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Healing at 12-month follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startOct 2006
- Primary completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apexum Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitoring: Quail CRO, Romania, Medistat Ltd., Israel
- Investigators
- Dragos Slavescu, DMD, Principal investigator, Titu Maiorescu UniversityDan Dragomirescu, DMD, Principal investigator, Cabinet Stomatologic Dr Dan Dragomirescu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762840
- Sponsor's protocol ID
- Apexum Trial
- Status last verified
- Jun 2009
- First submitted
- 29 Sep 2008
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Efficacy of the Apexum Ablator in Subjects With Periapical Lesions Associated With Root Canal Infection
- ClinicalTrials.gov ID
- NCT00762840
- Acronym / sponsor ID
- Apexum Trial
- Conditions
- Periapical Periodontitis
- Keywords
- Periapical lesions, Apical Periodontitis, endodontic procedure, root canal treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Apexum Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Monitoring: Quail CRO, Romania, Medistat Ltd., Israel
- Study start
- Oct 2006
- Primary completion
- Apr 2010 (estimated)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apexum | Experimental | Device: the Apexum Protocol, Procedure: Conventional endodontic procedurethe 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. |
| Control | Active comparator | Procedure: Conventional endodontic procedurethe tooth is subject to conventional endodontic procedure alone, (standard root canal treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Apexum Protocolusing the apexum kit for minimally invasive removal of periapical lesion tissue. | Device | Apexum |
| Conventional endodontic procedureStandard root canal treatment | Procedure or surgery | Apexum, Control |
Primary outcome
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
1 secondary outcome
Healing at 12-month follow-up.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dragos Slavescu, DMD principal investigator
Titu Maiorescu University
Dan Dragomirescu, DMD principal investigator
Cabinet Stomatologic Dr Dan Dragomirescu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Apexum Protocol and Conventional endodontic procedure in people with Periapical Periodontitis, run by Apexum Ltd. at 2 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronen Huber, DMD (+972-54-6611677, ronen@apexum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2009.