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Endodontic InflammationNCT03551587

Comparison Between the Vibringe and the Conventional Needle

A study testing Vibringe in people with Endodontic Inflammation, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Endodontic Inflammation
What is being tested?
Vibringe
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteEgypt
Study dates
28 Nov 2017to 28 Feb 2019
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 25 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age between 25-45 years old.
  • Males or Females.
  • Single rooted teeth with:
  • Symptomatic irreversible pulpitis .
  • Normal periapical radiographic appearance or slight widening in lamina dura.

Who cannot join

  • Patients on medication for chronic pain.
  • Patients having significant systemic disorders.
  • Teeth that have :
  • Vital pulp tissues.
  • Swelling or fistulous tract
  • Acute or chronic peri-apical abscess
Show all 10Show fewer
  • Greater than grade I mobility
  • Pocket depth greater than 5mm
  • No possible restorability
  • Previous endodontic treatment.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo university

    Cairo

Other trials in Egypt

About this study

Official title: Comparative Evaluation Of Postoperative Pain After Using Sonic Vibringe Irrigation System Versus Conventional Irrigation In Single Rooted Teeth With Symptomatic Irreversible Pulpitis : A Randomized Clinical Controlled Trial

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.

Read the 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.

Being tested
Vibringe
Medical subject headings
Pulpitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VibringeDevice

    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.

Study groups in NCT03551587
Study groupRoleWhat they receive
Irrigant delivered by the VibringeExperimentalExperimental group: The irrigant will be delivered and sonically activated with the Vibringe system.
Receives: Device: Vibringe
Irrigation by Conventional needleNo interventionControl group: Irrigation procedures will br performed with a conventional method using conventional gauge 24 needle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain intensity ( post operative pain )

    post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: "severe pain, analgesic had no effect in relieving the pain".

    Measured: 6 hours post- obturation.

  2. pain intensity ( post operative pain )

    post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: "severe pain, analgesic had no effect in relieving the pain".

    Measured: 12 hours post- obturation.

  3. pain intensity ( post operative pain )

    post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: "severe pain, analgesic had no effect in relieving the pain".

    Measured: 24 hours post- obturation.

  4. pain intensity ( post operative pain )

    post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: "severe pain, analgesic had no effect in relieving the pain".

    Measured: 48 hours post- obturation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2018
  2. Study start28 Nov 2017
  3. Primary completion27 Jan 2019
  4. Study completion28 Feb 2019

Resources

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03551587
Sponsor's protocol ID
Vibringe_Postoperative_pain
Status last verified
Aug 2019
First submitted
29 May 2018
Last updated
2 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Vibringe in people with Endodontic Inflammation, run by Cairo University at 1 site in Egypt.

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 5 inclusion and 10 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: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain intensity ( post operative pain ) (time frame: 6 hours post- obturation.). The study lists 4 primary outcomes in all. 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 2 Aug 2019.

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