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.
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.
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.
- Conditions
- Endodontic Inflammation
- 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 group | Role | What they receive |
|---|---|---|
| Irrigant delivered by the Vibringe | Experimental | Experimental group:
The irrigant will be delivered and sonically activated with the Vibringe system. Receives: Device: Vibringe |
| Irrigation by Conventional needle | No intervention | Control 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.
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.
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.
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.
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.
- First posted11 Jun 2018
- Study start28 Nov 2017
- Primary completion27 Jan 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic InflammationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara shehata, Cairo University
- Investigators
- Professor Heba El Far, Study director, Cairo UniversityFaculty of Dentistry, Study chair, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03551587
- Acronym / sponsor ID
- Vibringe_Postoperative_pain
- Conditions
- Endodontic Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 27 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 11 Jun 2018 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrigant delivered by the Vibringe | Experimental | Device: VibringeExperimental group: The irrigant will be delivered and sonically activated with the Vibringe system. |
| Irrigation by Conventional needle | No intervention | –Control group: Irrigation procedures will br performed with a conventional method using conventional gauge 24 needle. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Patients on medication for chronic pain.
- Patients having significant systemic disorders.
- Teeth that have :
- Vital pulp tissues.
- Swelling or fistulous tract
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 |
|---|---|---|
| VibringeThe 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. | Device | Irrigant delivered by the Vibringe |
Primary outcome
pain intensity ( post operative pain )
Time frame: 6 hours post- obturation.
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".
pain intensity ( post operative pain )
Time frame: 12 hours post- obturation.
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".
pain intensity ( post operative pain )
Time frame: 24 hours post- obturation.
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".
pain intensity ( post operative pain )
Time frame: 48 hours post- obturation.
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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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.
Professor Heba El Far study director
Cairo University
Faculty of Dentistry study chair
Cairo University
1 site in 1 country: see every site and its status.
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.