Apical PeriodontitisPhase 4NCT07599254
Effect of Two Different Irrigation Protocols and Activation Techniques on Postoperative Pain in Single-visit Endodontic Retreatment: Prospective Randomized Clinical Trial
A Phase 4 study testing root canal irrigation in people with Apical Periodontitis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The relationship between different root canal irrigation techniques and pain after root canal treatment Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- root canal irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 15 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- o Patients aged 18-60 years who are classified as medically healthy (ASA I or II),
- Mature, single-rooted and canal teeth that had root canal treatment at least four years ago,
- Teeth with previous root canal obturation 2-4 mm short of the apex,
- Teeth that do not need periodontal and prosthetic treatment and whose periapical index score (PAI) is between 2 and 4 ,
- Teeth with single root and canal diagnosed with asymptomatic apical periodontitis,
- Teeth suitable for rubber dam isolation.
Who cannot join
- o Patients who had taken analgesics, antibiotics, or corticosteroids within two weeks before root canal retreatment,
- Teeth exhibiting periodontal attachment loss,
- Presence of vertical root fractures, external root resorption, or perforations,
- Teeth with retained broken instruments,
- Non-restorable teeth,
- Patients in the pregnancy and breastfeeding period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University
Kayseri
Erciyes University Erciyes University, +9 (0352) 207 66 00, dent@erciyes.edu.tr
About this study
The relationship between different root canal irrigation techniques and pain after root canal treatment
- Conditions
- Apical Periodontitis
- Being tested
- root canal irrigation
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal irrigationDrug
Root canal irrigation and postoperative pain
| Study group | Role | What they receive |
|---|---|---|
| NaOCl/EDTA+CNI Group | Experimental | İrrigation Receives: Drug: root canal irrigation |
| NaOCl/EDTA+PUA Group | Experimental | Not described Receives: Drug: root canal irrigation |
| NaOCl/Dual Rinse HEDP+CNI Group | Experimental | Not described Receives: Drug: root canal irrigation |
| NaOCl/Dual Rinse HEDP+PUA Group | Experimental | Not described Receives: Drug: root canal irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the relationship between different root canal irrigation techniques and post-canal treatment pain using surveys.
Measured: 3-5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Jan 2025
- Primary completion5 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ipek Eraslan Akyuz, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599254
- Sponsor's protocol ID
- 2025/2
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Irrigation Protocols and Activation Techniques on Postoperative Pain in Single-visit Endodontic Retreatment: Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07599254
- Acronym / sponsor ID
- 2025/2
- Conditions
- Apical Periodontitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 5 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 20 May 2026 (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 relationship between different root canal irrigation techniques and pain after root canal treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NaOCl/EDTA+CNI Group | Experimental | Drug: root canal irrigationİrrigation |
| NaOCl/EDTA+PUA Group | Experimental | Drug: root canal irrigation |
| NaOCl/Dual Rinse HEDP+CNI Group | Experimental | Drug: root canal irrigation |
| NaOCl/Dual Rinse HEDP+PUA Group | Experimental | Drug: root canal irrigation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- o Patients aged 18-60 years who are classified as medically healthy (ASA I or II),
Key exclusion criteria (6 listed)
- o Patients who had taken analgesics, antibiotics, or corticosteroids within two weeks before root canal retreatment,
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 |
|---|---|---|
| root canal irrigationRoot canal irrigation and postoperative pain | Drug | NaOCl/Dual Rinse HEDP+CNI Group, NaOCl/Dual Rinse HEDP+PUA Group, NaOCl/EDTA+CNI Group, NaOCl/EDTA+PUA Group |
Primary outcome
Evaluation of the relationship between different root canal irrigation techniques and post-canal treatment pain using surveys.
Time frame: 3-5 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis
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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 recruitingObservational study
Neurokinin A and Matrix Metalloproteinase 9 Levels in Gingival Crevicular Fluid Samples of Teeth With Symptomatic Irreversible Pulpitis With Symptomatic Apical Periodontitis
Symptomatic Irreversible Pulpitis With Apical Peridontitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing root canal irrigation in people with Apical Periodontitis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 May 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İPEK E ERASLAN AKYÜZ (+905385591409, ipekemamak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the relationship between different root canal irrigation techniques and post-canal treatment pain using surveys. (time frame: 3-5 month). 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 20 May 2026.