Periapical Periodontitis Clinical Trial
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03102879 -
Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration.
|
N/A | |
Completed |
NCT00226148 -
Immediate Implant Placement in the Molar Regions
|
Phase 0 | |
Completed |
NCT05718596 -
Quantitative Assessment of the Efficacy of Sweeps Laser Activation Systems
|
N/A | |
Recruiting |
NCT05525013 -
Effect of Simvastatin Versus Calcium Hydroxide Intracanal Medications on Post-operative Pain and Interleukin 6 and 8
|
N/A | |
Active, not recruiting |
NCT05555043 -
Comparison of Clinical Outcomes Between GentleWave® and Biolase®
|
N/A | |
Recruiting |
NCT06322979 -
Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth
|
N/A | |
Completed |
NCT02947763 -
Single Versus Multiple Visits Endodontic Treatment
|
Phase 1 | |
Completed |
NCT05857436 -
Relationship Apical Periodontitis and the Main Bacterial Species in the Oral Microbiota
|
N/A | |
Active, not recruiting |
NCT03660163 -
Assessment of the Outcome of Endodontic Treatment Using Cone Beam Computed Tomography.
|
||
Completed |
NCT02801552 -
Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using PRF
|
N/A | |
Completed |
NCT02632513 -
Effect of Passive Ultrasonic Irrigation on Success of Primary Endodontic Treatment
|
N/A | |
Completed |
NCT01312194 -
Periapical Healing After One or Two-visits to Endodontic Treatment in Adolescents Patients
|
N/A | |
Completed |
NCT00223327 -
Measurement of Bite Force in Humans
|
Phase 0 | |
Completed |
NCT05297747 -
Adrenomedullin Upregulation in Apical Periodontitis
|
N/A | |
Completed |
NCT03708081 -
Comparative Evaluation of Different File Systems in Postoperative Pain
|
||
Recruiting |
NCT01799187 -
Research of Revascularization in Immature Teeth With Periapical Periodontitis
|
N/A | |
Completed |
NCT06023901 -
The Importance of Prostaglandin and Nitric Oxide Synthesis in Apical Periodontitis
|
N/A | |
Completed |
NCT02747082 -
Antibacterial Effectiveness of Two Root Canal Irrigants
|
Phase 2 | |
Completed |
NCT06339905 -
The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success
|
N/A | |
Completed |
NCT05719987 -
Biodentine as an Apical Plug in Immature Permanent Molars
|
N/A |