PainNCT06528574
Postoperative Pain After Activation of Irrigant
A study testing Conventional root canal treatment, Ultrasonic and Apical negative pressure in people with Pain, run by Cleveland Dental Institute at 1 site in United States.
Trial summary
The purpose of this research is to analyze the levels of pain after cleaning and shaping in individuals who are receiving root canal therapy using the IVAC irrigation approach, and those who are treated with ultrasonic irrigation techniques, negative pressure irrigation technique and traditional irrigation techniques. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Conventional root canal treatment, Ultrasonic and Apical negative pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 30 Apr 2025
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females Age :20-50 Mandibular mature first molars with symptomatic acute pulpitis Medically free patients
Who cannot join
- Pulp necrosis or apical periodontitis Periodontal disease Vertical root fracture Radiographic apical radiolucency
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cleveland Dental Institute
Cleveland, Ohio, 44128
Ahmed A Hashem, PhD, 440-502-1591, a.hashem@cdiohio.org
Waleed Elmallah, 2163336695, w.elmallah@cdiohio.org
About this study
Official title: Incidence of Postoperative Pain After Activation of Irrigant With Apical Negative Pressure and Ultrasonics in Mandibular Molar Teeth With Irreversible Pulpitis: A Randomized Controlled Trial
The purpose of this research is to analyze the levels of pain after cleaning and shaping in individuals who are receiving root canal therapy using the IVAC irrigation approach, and those who are treated with ultrasonic irrigation techniques, negative pressure irrigation technique and traditional irrigation techniques.
PICOTS Question:
Read more
Does the new Dent's iVac irrigation protocol has an effect on reduction of postoperative pain
By enlisting at least 84 suitable individuals who are undergoing the identical endodontic procedure.
pain will be measures by assessing pain levels through a standardized numerical rate scale (NRS) at certain time intervals after root canal treatment, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours.
- Conditions
- Pain
- Being tested
- Conventional root canal treatment, Ultrasonic, Apical negative pressure, Combined Ultrasonic and negative pressure
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional root canal treatmentDevice
Root canals will be irrigated by only side perforated needle
UltrasonicDevice
Root canals will finally receive activation of the irrigant by the ultrasonic part of the IVAC system
Apical negative pressureDevice
Root canals will finally receive activation of the irrigant by the negative pressure part of the IVAC system
Combined Ultrasonic and negative pressureDevice
Root canals will finally receive activation of the irrigant by the IVAC system which is a combination of ultrasonic and apical negative pressure procedures.
| Study group | Role | What they receive |
|---|---|---|
| Conventional root canal treatment | Active comparator | Irrigation will be performed with side vented needles only Receives: Device: Conventional root canal treatment |
| Irrigant activation with Ultrasonic | Experimental | Final irrigant activation will be done by ultrasonic Receives: Device: Ultrasonic |
| Irrigant activation with negative pressure | Experimental | Final irrigant activation will be performed with apical negative pressure Receives: Device: Apical negative pressure |
| Irrigant activation with both Ultrasonic and negative pressure | Experimental | Final irrigation with a combination of ultrasonic and apical negative pressure using the IVAC device. Receives: Device: Combined Ultrasonic and negative pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Scale (NRS)
Pain will be assessed during the numerical rate scale (NRS) which has a scale from 0 to 10, where 0 is no pain while 10 is most unbearable one.
Measured: Preoperative, 6 hours, 12 hours, 24 hours, 48 hours and 72 hour post-procedure.
Secondary outcomes (1)
Analgesics intake
The patient will be advised to take analgesics in case of unbearable pain and record this. Number of tablets and the time will be recorded
● The satisfaction of patients regarding the pain management intervention at the follow-up
Measured: 6 hours, 12 hours, 24 hours,48 hours and 72 hour post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleveland Dental Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed A Hashem, PhD, Study chair, Cleveland Dental Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528574
- Sponsor's protocol ID
- CDIENDO0001
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Pain After Activation of Irrigant With Apical Negative Pressure and Ultrasonics in Mandibular Molar Teeth With Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06528574
- Acronym / sponsor ID
- CDIENDO0001
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cleveland Dental InstituteUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 30 Jul 2024 (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 purpose of this research is to analyze the levels of pain after cleaning and shaping in individuals who are receiving root canal therapy using the IVAC irrigation approach, and those who are treated with ultrasonic irrigation techniques, negative pressure irrigation technique and traditional irrigation techniques.
PICOTS Question:
Does the new Dent's iVac irrigation protocol has an effect on reduction of postoperative pain
By enlisting at least 84 suitable individuals who are undergoing the identical endodontic procedure.
pain will be measures by assessing pain levels through a standardized numerical rate scale (NRS) at certain time intervals after root canal treatment, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional root canal treatment | Active comparator | Device: Conventional root canal treatmentIrrigation will be performed with side vented needles only |
| Irrigant activation with Ultrasonic | Experimental | Device: UltrasonicFinal irrigant activation will be done by ultrasonic |
| Irrigant activation with negative pressure | Experimental | Device: Apical negative pressureFinal irrigant activation will be performed with apical negative pressure |
| Irrigant activation with both Ultrasonic and negative pressure | Experimental | Device: Combined Ultrasonic and negative pressureFinal irrigation with a combination of ultrasonic and apical negative pressure using the IVAC device. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males and females Age :20-50 Mandibular mature first molars with symptomatic acute pulpitis Medically free patients
Key exclusion criteria (2 listed)
- Pulp necrosis or apical periodontitis Periodontal disease Vertical root fracture Radiographic apical radiolucency
- -
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 root canal treatmentRoot canals will be irrigated by only side perforated needle | Device | Conventional root canal treatment |
| UltrasonicRoot canals will finally receive activation of the irrigant by the ultrasonic part of the IVAC system | Device | Irrigant activation with Ultrasonic |
| Apical negative pressureRoot canals will finally receive activation of the irrigant by the negative pressure part of the IVAC system | Device | Irrigant activation with negative pressure |
| Combined Ultrasonic and negative pressureRoot canals will finally receive activation of the irrigant by the IVAC system which is a combination of ultrasonic and apical negative pressure procedures. | Device | Irrigant activation with both Ultrasonic and negative pressure |
Primary outcome
Numerical Pain Scale (NRS)
Time frame: Preoperative, 6 hours, 12 hours, 24 hours, 48 hours and 72 hour post-procedure.
Pain will be assessed during the numerical rate scale (NRS) which has a scale from 0 to 10, where 0 is no pain while 10 is most unbearable one.
1 secondary outcome
Analgesics intake
Time frame: 6 hours, 12 hours, 24 hours,48 hours and 72 hour post-procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Ahmed A Hashem, PhD study chair
Cleveland Dental Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional root canal treatment, Ultrasonic and Apical negative pressure in people with Pain, run by Cleveland Dental Institute at 1 site in United States.
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 1 inclusion and 2 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 30 Jul 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Hashem, PhD (4405021591, a.hashem@cdiohio.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Scale (NRS) (time frame: Preoperative, 6 hours, 12 hours, 24 hours, 48 hours and 72 hour post-procedure.). 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 30 Jul 2024.