Tooth,Non-vitalNCT02912286
Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques
A study testing conventional needle irrigation, passive ultrasonic irrigation and sonic irrigation in people with Tooth,Non-vital, run by Cairo University.
Trial summary
The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth,Non-vital
- What is being tested?
- conventional needle irrigation, passive ultrasonic irrigation and sonic irrigation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to May 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males or Females
- Age between 16-60 years old
- Permanent Mandibular molars with:
- Non-vital response of pulp tissue
- Absence of spontaneous pain
Who cannot join
- Pregnant females
- Patients having significant systemic disorder
- Patients received analgesics, anti-inflammatory or antibiotic in the last 24 hours
- Teeth that have:
- Vital pulp tissues
- Association with swelling or fistulous tract
Show all 10Show fewer
- Acute periapical abscess
- Greater than grade I mobility
- Pocket depth greater than 5mm
- Previous endodontic treatment
About this study
Official title: Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques: A Randomized Controlled Trial
The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.
Read the detailed description
Different irrigation delivery systems are introduced to the market aiming to improve root canals disinfection. The conventional endodontic needle is commonly used because of its ease in use and good control of needle depth and irrigant volume. However it carries a higher risk of extruding the solution periapically because of positive pressure used in solution delivery.
Passive ultrasonic irrigation is a noncutting irrigation technique that is done with ultrasonically activated files with continuous or intermittent flow of irrigant. It was shown that it is effective in removing remnants of pulp tissue, dentin debris and planktonic bacteria.
The vibringe (Cavex Holland BV, Haarlem, the Netherlands) is an irrigation device that combines manual delivery and sonic activation of the irrigant.
The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.
- Conditions
- Tooth,Non-vital
- Being tested
- conventional needle irrigation, passive ultrasonic irrigation, sonic irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional needle irrigationDevice
conventional side-vented syringe used to deliver irrigant in root canal treatment
passive ultrasonic irrigationDevice
ultrasonic tip (IrriSafe) activate the irrigant after mechanical preparation in root canal treatment
sonic irrigationDevice
vibringe system is a sonic device that deliver and agitate the irrigant
| Study group | Role | What they receive |
|---|---|---|
| conventional needle irrigation | Active comparator | side-vented needle used for endodontic irrigation Receives: Device: conventional needle irrigation |
| passive ultrasonic irrigation | Experimental | IrriSafe ultrasonic tip used for irrigation agitation in endodontic treatment Receives: Device: passive ultrasonic irrigation |
| sonic irrigation | Experimental | Vibringe is a sonic irrigation system used to irrigate and activate the irrigant at same time Receives: Device: sonic irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain measured by numerical rate scale
Numerical rate scale (NRS) consists of a line graded from 0-10 where 0 indicates no pain and 10 indicates worst pain, patient will choose the number that describe his pain level.
Measured: 4 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth,Non-vitalStudies 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
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Samy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912286
- Sponsor's protocol ID
- CEBD-CU-2016-09-200
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02912286
- Acronym / sponsor ID
- CEBD-CU-2016-09-200
- Conditions
- Tooth,Non-vital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 23 Sep 2016 (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 aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.
Detailed description
Different irrigation delivery systems are introduced to the market aiming to improve root canals disinfection. The conventional endodontic needle is commonly used because of its ease in use and good control of needle depth and irrigant volume. However it carries a higher risk of extruding the solution periapically because of positive pressure used in solution delivery.
Passive ultrasonic irrigation is a noncutting irrigation technique that is done with ultrasonically activated files with continuous or intermittent flow of irrigant. It was shown that it is effective in removing remnants of pulp tissue, dentin debris and planktonic bacteria.
The vibringe (Cavex Holland BV, Haarlem, the Netherlands) is an irrigation device that combines manual delivery and sonic activation of the irrigant.
The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional needle irrigation | Active comparator | Device: conventional needle irrigationside-vented needle used for endodontic irrigation |
| passive ultrasonic irrigation | Experimental | Device: passive ultrasonic irrigationIrriSafe ultrasonic tip used for irrigation agitation in endodontic treatment |
| sonic irrigation | Experimental | Device: sonic irrigationVibringe is a sonic irrigation system used to irrigate and activate the irrigant at same time |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Males or Females
- Age between 16-60 years old
- Permanent Mandibular molars with:
Key exclusion criteria (10 listed)
- Pregnant females
- Patients having significant systemic disorder
- Patients received analgesics, anti-inflammatory or antibiotic in the last 24 hours
- Teeth that have:
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 |
|---|---|---|
| conventional needle irrigationconventional side-vented syringe used to deliver irrigant in root canal treatment | Device | conventional needle irrigation |
| passive ultrasonic irrigationultrasonic tip (IrriSafe) activate the irrigant after mechanical preparation in root canal treatment | Device | passive ultrasonic irrigation |
| sonic irrigationvibringe system is a sonic device that deliver and agitate the irrigant | Device | sonic irrigation |
Primary outcome
postoperative pain measured by numerical rate scale
Time frame: 4 hours after treatment
Numerical rate scale (NRS) consists of a line graded from 0-10 where 0 indicates no pain and 10 indicates worst pain, patient will choose the number that describe his pain level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Tooth,Non-vital
Enrolling by invitation
Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
Pain, Postoperative, Root Resorption
Recruiting
To Evaluate and Compare the Effect of Orthograde and Retrograde MTA Root End Filling After Periapical Surgery in Posteriors
Non Vital Teeth, Persistent Symptomatic Apical Periodontitis
RecruitingObservational study
Professional Practices Regarding Treatment of Non-vital Primary Teeth Among Dental Surgeons in France
Pulpitis - Irreversible, Pulp Necrosis
Not yet recruiting
Effect of Graphene Oxide on Vital and Non-Vital Primary Teeth Compared to the Conventional Techniques
Primary Teeth Indicated for Pulp Therapy
Recruiting
Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®
Tooth Extraction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing conventional needle irrigation, passive ultrasonic irrigation and sonic irrigation in people with Tooth,Non-vital, run by Cairo University.
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: status not confirmed, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
postoperative pain measured by numerical rate scale (time frame: 4 hours after treatment). 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 23 Sep 2016.