Pulpitis - IrreversibleNCT06573710
Correlation Between Postoperative Pain and Apical Extrusion of Different Irrigation Activation Techniques
A study testing sonic activator, LASER activation and Ultrasonic activation in people with Pulpitis - Irreversible, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this clinical trial is : To evaluate effect of different techniques of irrigant activation: 1. LASER activation 2. sonic activation 3. ultrasonic activation 4. passive needle irrigation On: 1. Postoperative pain in vital teeth (Randomized controlled trial) 2. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- sonic activator, LASER activation and Ultrasonic activation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 May 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
- Age group 18-50 years
- Males and females
- Lower molars with symptomatic irreversible pulpitis without apical periodontitis
Who cannot join
- Patients with uncontrolled health conditions
- Immunocompromised patients
- Teeth with periodontal diseases
- Teeth with calcified canals
- pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Postoperative Pain and Apical Extrusion of Different Irrigation Activation Techniques (Randomized Controlled Trial - an In Vitro Study)
The aim of this clinical trial is :
To evaluate effect of different techniques of irrigant activation:
- LASER activation
- sonic activation
- ultrasonic activation
- passive needle irrigation
On:
- Postoperative pain in vital teeth (Randomized controlled trial)
- Amount of apical extrusion (In vitro study) Participants will describe their preoperative pain and postoperative pain level at fixed time interval Research will compare postoperative pain accompanied with different irrigant activation techniques and correlate it to amount of debris extrusion
- Conditions
- Pulpitis - Irreversible
- Being tested
- sonic activator, LASER activation, Ultrasonic activation, passive irrigation with Endodontic needle
- Keywords
- irrigant , ultrasonic, LASER , sonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonic activatorDevice
Polyamide EDDY tips 28mm long is inserted in the canal 2mm short of the working length operated at 6,000 Hz. Activation is done for three cycles each for 20sec. The tip is moved vertically in up and down motion, 1ml is used for each activation cycle followed by 2ml 17% EDTA20
LASER activationDevice
Diode laser 980nm is used to activate the irrigant using fiber optic tip of (200micrometer) and power of 1.5w continuous mode. The tip is placed 2 mm shorter than the working length. Laser irradiation is done for each canal for 20 secs repeated over three cycles for total time of 60 secs and 10 secs pauses between each cycle
Ultrasonic activationDevice
ED60tip is used with ultrasonic device operated on mode E and inserted in the canal 2mm short of the working. Activation is done for three cycles each for 20 sec. The tip is moved vertically in up and down motion,1ml is used for each activation cycle followed by 2ml 17% EDTA
passive irrigation with Endodontic needleDevice
Each canal is irrigated with side vented endodontic needle 30G Placed 2mm short of the working length with total time of 60 secs followed by 2ml 17% EDTA
| Study group | Role | What they receive |
|---|---|---|
| Sonic activation | Experimental | Not described Receives: Device: sonic activator |
| LASER activation | Experimental | Not described Receives: Device: LASER activation |
| Ultrasonic activation | Experimental | Not described Receives: Device: Ultrasonic activation |
| passive irrigation with Endodontic needle | Active comparator | Not described Receives: Device: passive irrigation with Endodontic needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of postoperative pain
Numerical Rating Scale
Measured: 8,24,48 hours and one week
Secondary outcomes (1)
Frequency of analgesic intake
number of tablets
Measured: 8,24,48 hours and one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Feb 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573710
- Sponsor's protocol ID
- AinShams Uni Endodontics
- Status last verified
- Aug 2024
- First submitted
- 24 Aug 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Postoperative Pain and Apical Extrusion of Different Irrigation Activation Techniques (Randomized Controlled Trial - an In Vitro Study)
- ClinicalTrials.gov ID
- NCT06573710
- Acronym / sponsor ID
- AinShams Uni Endodontics
- Conditions
- Pulpitis - Irreversible
- Keywords
- irrigant , ultrasonic, LASER , sonic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 27 Aug 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 aim of this clinical trial is :
To evaluate effect of different techniques of irrigant activation:
- LASER activation
- sonic activation
- ultrasonic activation
- passive needle irrigation
On:
- Postoperative pain in vital teeth (Randomized controlled trial)
- Amount of apical extrusion (In vitro study) Participants will describe their preoperative pain and postoperative pain level at fixed time interval Research will compare postoperative pain accompanied with different irrigant activation techniques and correlate it to amount of debris extrusion
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sonic activation | Experimental | Device: sonic activator |
| LASER activation | Experimental | Device: LASER activation |
| Ultrasonic activation | Experimental | Device: Ultrasonic activation |
| passive irrigation with Endodontic needle | Active comparator | Device: passive irrigation with Endodontic needle |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age group 18-50 years
- Males and females
- Lower molars with symptomatic irreversible pulpitis without apical periodontitis
Key exclusion criteria (5 listed)
- Patients with uncontrolled health conditions
- Immunocompromised patients
- Teeth with periodontal diseases
- Teeth with calcified canals
- pregnant patients
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 |
|---|---|---|
| sonic activatorPolyamide EDDY tips 28mm long is inserted in the canal 2mm short of the working length operated at 6,000 Hz. Activation is done for three cycles each for 20sec. The tip is moved vertically in up and down motion, 1ml is used for each activation cycle followed by 2ml 17% EDTA20 | Device | Sonic activation |
| LASER activationDiode laser 980nm is used to activate the irrigant using fiber optic tip of (200micrometer) and power of 1.5w continuous mode. The tip is placed 2 mm shorter than the working length. Laser irradiation is done for each canal for 20 secs repeated over three cycles for total time of 60 secs and 10 secs pauses between each cycle | Device | LASER activation |
| Ultrasonic activationED60tip is used with ultrasonic device operated on mode E and inserted in the canal 2mm short of the working. Activation is done for three cycles each for 20 sec. The tip is moved vertically in up and down motion,1ml is used for each activation cycle followed by 2ml 17% EDTA | Device | Ultrasonic activation |
| passive irrigation with Endodontic needleEach canal is irrigated with side vented endodontic needle 30G Placed 2mm short of the working length with total time of 60 secs followed by 2ml 17% EDTA | Device | passive irrigation with Endodontic needle |
Primary outcome
Evaluation of postoperative pain
Time frame: 8,24,48 hours and one week
Numerical Rating Scale
1 secondary outcome
Frequency of analgesic intake
Time frame: 8,24,48 hours and one week
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 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pulpitis - Irreversible
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sonic activator, LASER activation and Ultrasonic activation in people with Pulpitis - Irreversible, run by Ain Shams 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 3 inclusion and 5 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 30 Jun 2026. 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?
Evaluation of postoperative pain (time frame: 8,24,48 hours and one week). 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 Jun 2026.