Irrigation ActivationNCT05450003
Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and on Post-Operative Pain
A study testing Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation in people with Irrigation Activation, run by Tanta University at 1 site in Egypt.
Trial summary
Irrigation activation in endodontics is considered now a very important step for the success of root canal treatment. In this study, the investigator will examine the effect of two recent activation systems ( XP-endo Finisher file and the new sonic EDDY system) in comparison with the conventional needle irrigation on… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Irrigation Activation
- What is being tested?
- Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 25 Nov 2022
- 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
- Asymptomatic vital/non vital teeth requiring root canal treatment.
- Teeth with sound periodontal apparatus.
- Teeth without pus or inflammatory exudates draining through the canal.
- Teeth without anatomic variations.
- Teeth with sinus tract.
- Teeth without history of trauma.
- Patients not on analgesics or sedative medication prior to root canal therapy
Who cannot join
- • Patients with any systemic diseases.
- Pregnant or lactating patients.
- Immunocompromised patients.
- Apparently thin roots in which apical preparation with #40 file would be overzealous.
- Patient allergic to anything used in this procedure especially rubber dam material and Iohexol (radiographic contrast media).
- Teeth with calcified canals.
- Patients with acute apical periodontitis, acute apical abscess, and weeping canals.
- Necrotic painful teeth with the absence of sinus tract for drainage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth Into Root Canals and on Post-Operative Pain After Single-Visit Endodontic Treatment
Irrigation activation in endodontics is considered now a very important step for the success of root canal treatment. In this study, the investigator will examine the effect of two recent activation systems ( XP-endo Finisher file and the new sonic EDDY system) in comparison with the conventional needle irrigation on irrigant penetration depth into root canals using radiopaque contrast media and digital radiography and on the postoperative pain after single-visit endodontic treatment using a visual analog scale.
- Conditions
- Irrigation Activation
- Being tested
- Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigationDevice
irrigation activation using 3 different irrigation activation systems including xp endo finisher file , new sonic eddy system and conventional needle syringe irrigation
| Study group | Role | What they receive |
|---|---|---|
| xp endo finisher file | Other | Not described Receives: Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation |
| new sonic EDDY system | Other | Not described Receives: Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation |
| syringe needle irrigation | Other | Not described Receives: Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
irrigant penetration depth
measurement of irrigant penetration depth using radioaque media and digital radiography
Measured: through study completion, an average of 3 months
postoperative pain
evaluation of postoperative pain using visual analog scale VAS with scores from 0 to 100. score 0 indicated no pain while score 100 indicates maximum pain
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Aug 2022
- Primary completion12 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irrigation ActivationStudies 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
- Sequential
- Model description
- the study will evaluate 3 groups of patients each consists of 10 participants receiving different type of irrigation activation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Fawzy Kotb Elgazzar, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450003
- Sponsor's protocol ID
- Elgazzar YF1
- Status last verified
- May 2023
- First submitted
- 18 Jun 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Elgazzar YFK, Darrag AM, Attia DAM. Effect of XP-endo Finisher and EDDY activation on post-operative pain after single-visit endodontic treatment: a randomized controlled clinical trial. Sci Rep. 2025 Nov 4;15(1):38476. doi: 10.1038/s41598-025-23628-1.
PubMed 41188367
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth Into Root Canals and on Post-Operative Pain After Single-Visit Endodontic Treatment
- ClinicalTrials.gov ID
- NCT05450003
- Acronym / sponsor ID
- Elgazzar YF1
- Conditions
- Irrigation Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 8 Jul 2022 (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.
Irrigation activation in endodontics is considered now a very important step for the success of root canal treatment. In this study, the investigator will examine the effect of two recent activation systems ( XP-endo Finisher file and the new sonic EDDY system) in comparison with the conventional needle irrigation on irrigant penetration depth into root canals using radiopaque contrast media and digital radiography and on the postoperative pain after single-visit endodontic treatment using a visual analog scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- the study will evaluate 3 groups of patients each consists of 10 participants receiving different type of irrigation activation.
| Arm | Type | Receives |
|---|---|---|
| xp endo finisher file | Other | Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation |
| new sonic EDDY system | Other | Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation |
| syringe needle irrigation | Other | Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Asymptomatic vital/non vital teeth requiring root canal treatment.
- Teeth with sound periodontal apparatus.
- Teeth without pus or inflammatory exudates draining through the canal.
- Teeth without anatomic variations.
- Teeth with sinus tract.
Key exclusion criteria (8 listed)
- • Patients with any systemic diseases.
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 |
|---|---|---|
| Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigationirrigation activation using 3 different irrigation activation systems including xp endo finisher file , new sonic eddy system and conventional needle syringe irrigation | Device | new sonic EDDY system, syringe needle irrigation, xp endo finisher file |
Primary outcome
irrigant penetration depth
Time frame: through study completion, an average of 3 months
measurement of irrigant penetration depth using radioaque media and digital radiography
postoperative pain
Time frame: through study completion, an average of 3 months
evaluation of postoperative pain using visual analog scale VAS with scores from 0 to 100. score 0 indicated no pain while score 100 indicates maximum 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 19 May 2023.
- Derived from this study: PubMed 41188367Elgazzar YFK, Darrag AM, Attia DAM. Effect of XP-endo Finisher and EDDY activation on post-operative pain after single-visit endodontic treatment: a randomized controlled clinical trial. Sci Rep. 2025 Nov 4;15(1):38476. doi: 10.1038/s41598-025-23628-1.
Related trials for Irrigation Activation
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
Not yet recruiting
Laser-Activated Versus Passive Ultrasonic Irrigation in Endodontic Retreatment
Apical Periodontitis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Active, not recruiting
Effects of Irrigation Activation Methods on Periapical Healing in Chronic Apical Periodontitis
Chronic Apical Periodontitis
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 Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation in people with Irrigation Activation, run by Tanta 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 7 inclusion and 8 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 19 May 2023. 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?
irrigant penetration depth (time frame: through study completion, an average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05450003, which also lists 1 linked publication.
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 19 May 2023.