Comparison Between the Vibringe and the Conventional Needle
Condition: Endodontic Inflammation
MeSH terms: Pulpitis; Inflammation
Study type: Interventional

Summary: 
      The Vibringe is the first endodontic sonic irrigation system that enables delivery and
      activation of the irrigation solution in the root canal, in only one step. The activation of
      the disinfectant by acoustic streaming, enriches and completes the irrigation procedure and
      improves the success rate of endodontic treatments. It has been shown that this system
      significantly improves debridement. It also improves the disruption of the smear layer and
      biofilm by activating irrigation solutions.

      As there are no previous studies comparing the Vibringe system with other irrigation
      techniques under clinical settings, in this regard, the aim of this study is to evaluate
      whether irrigation with Vibringe provides more or less benefit in terms of postoperative pain
      when compared with the conventional needle technique.
    

Detailed description: 
      Postoperative pain is defined as the sensation of discomfort after endodontic intervention
      and is reported by 25%-40% of patients irrespective of pulp and peri-radicular status.
      According to the 2011 systematic review of Pak and White , the prevalence of pain in the
      first 24 hours is 40%, falling to 11% after 7 days. Dentinal debris, pulp tissue,
      microorganisms and irrigants can be conveyed to the peri-radicular tissues during root canal
      preparation and such extrusion of debris can lead to postoperative complications, such as
      flare-ups.

      Mechanical instrumentation and irrigation are used to remove vital and necrotic remnants of
      pulp tissue, debris, microbiota and their by-products from a root canal system. However,
      several studies using microcomputed tomography scanning imagery have shown that most of the
      areas of the main root canal wall remain untouched by the instruments. This emphasizes the
      importance of other means of cleaning and disinfecting all areas of the root canal.

      To enhance the effectiveness of cleaning and disinfecting all areas of the root canal,
      several irrigants are commonly used as initial and final rinses to overcome the shortcomings
      of using a single irrigant, such as sodium hypochlorite (NaOCl), ethylene-diaminetetraacetic
      acid or chlorhexidine. In addition to these various irrigants, numerous irrigation devices
      and needle tips have been developed with the aim of improving the delivery of irrigant
      throughout the root canal using sonic or ultrasonic energy and negative apical pressure.

      However, as well as the success of the irrigation devices in removing debris from the root
      canal, a safe irrigation delivery system is desirable to prevent periapical tissue damage and
      decrease post-endodontic pain. The available data on extrusion of irrigant when using these
      devices appears to be limited to laboratory studies.

      Rationale :

      The Vibringe is the first endodontic sonic irrigation system that enables delivery and
      activation of the irrigation solution in the root canal, in only one step. The activation of
      the disinfectant by acoustic streaming, enriches and completes the irrigation procedure and
      improves the success rate of endodontic treatments. It has been shown that this system
      significantly improves debridement. It also improves the disruption of the smear layer and
      biofilm by activating irrigation solutions.

      Vasconcelos et al at in vitro study at 2017 proved that groups using ultrasonic agitation
      presented a greater antibacterial effect than the other ones, even using saline solution as
      irrigant. Middha et al studied the effect of continuous ultrasonic irrigation on
      postoperative pain in mandibular molars with nonvital pulps concluded that a significant
      difference was observed between CUI and syringe irrigation on the first postoperative day
      following chemo-mechanical preparation. However, the benefit observed was not clinically
      relevant.

      It has been shown that the Vibringe results in an equal performance in canal and isthmus
      debridement efficacy when compared with needle irrigation in the apical region (9). In
      addition, it did not significantly alter sealer penetration compared with conventional
      needles. Furthermore, another recent study concluded that the Vibringe extruded more debris
      than conventional needle irrigation .

      Postoperative pain associated with root canal treatment is a poor indicator of long-term
      success; however, the occurrence and the control of pain are of clinical interest. So , this
      study will focus on evaluating postoperative discomfort due to the fact that Vibringe is an
      actively vibrating system, which may lead to postoperative discomfort.

      Objective of the study :

      As there are no previous studies comparing the Vibringe system with other irrigation
      techniques under clinical settings, in this regard, the aim of this study is to evaluate
      whether irrigation with Vibringe provides more or less benefit in terms of postoperative pain
      when compared with the conventional needle technique.
    

Intervention name(s): Vibringe
Intervention type(s): Device
Intervention description(s): The Vibringe is the first endodontic sonic irrigation system that enables delivery and activation of the irrigation solution in the root canal, in only one step.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment