Postoperative Pain After Endodontic TreatmentNCT07859384
Effects of Different Root Canal Filling Materials and Irrigation Agitation Techniques on Postoperative Pain in Teeth With Irreversible Pulpitis: A Randomized Clinical Trial
A study testing XP-Endo Finisher, EDDY and Passive Ultrasonic Activation in people with Postoperative Pain After Endodontic Treatment and Oral Health-Related Quality of Life, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This clinical study is designed to evaluate the effects of different irrigation agitation techniques and root canal sealers on postoperative pain and oral health-related quality of life in patients with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain After Endodontic Treatment, Oral Health-Related Quality of Life, Symptomatic Irreversible Pulpitis
- What is being tested?
- XP-Endo Finisher, EDDY and Passive Ultrasonic Activation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2026to 23 Feb 2027
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients with single-rooted teeth requiring endodontic retreatment.
- Individuals in good general health, classified as ASA Physical Status I.
- Teeth presenting normal anatomical structure and root morphology.
Who cannot join
- Patients who have used antibiotics or analgesic medications within the last month.
- Pregnant individuals and patients with systemic diseases (such as chronic illnesses, diabetes mellitus, hypertension).
- Teeth with root fractures or perforations.
- Patients presenting with high baseline pain levels, particularly those with a history of treatment-resistant pain.
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
Ankara University Faculty of Dentistry
Ankara, Ankara, 06100
Assistant Professor, +90 505 303 93 96, emiodabasi@gmail.com
ÖZGE KURT KAYA, DDS, +90 5457737969, Ozgekrtrs@gmail.com
About this study
This clinical study is designed to evaluate the effects of different irrigation agitation techniques and root canal sealers on postoperative pain and oral health-related quality of life in patients with symptomatic irreversible pulpitis. Postoperative pain following root canal treatment may affect patient comfort and satisfaction. The choice of irrigation agitation technique and root canal sealer may influence these outcomes. Irrigation agitation techniques are used to improve cleaning of the root canal system. XP-Endo Finisher, EDDY, and passive ultrasonic activation use different mechanisms to enhance this process. Root canal sealers, including the epoxy resin-based AH Plus and the calcium silicate-based NeoSealer Flo, also differ in their composition and biological properties. Clinical evidence regarding the combined effects of these techniques and sealers on patient-reported outcomes remains limited. In this randomized clinical trial, 324 patients aged 18-65 years requiring root canal treatment for a single-rooted, single-canal permanent tooth with symptomatic irreversible pulpitis will be allocated to six groups. Each group will receive one of three irrigation agitation techniques-XP-Endo Finisher, EDDY, or passive ultrasonic activation-in combination with either AH Plus or NeoSealer Flo. Root canal treatment will be completed in a single visit. Postoperative pain intensity will be assessed using a visual analog scale at 6, 12, 24, 48, and 72 hours and 7 days after treatment. Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 questionnaire before treatment and 7 days afterward. Analgesic use during the follow-up period will also be recorded. The primary objective is to compare postoperative pain among the six treatment groups. Secondary objectives include evaluating changes in oral health-related quality of life and analgesic consumption. The study will also investigate whether irrigation agitation techniques and root canal sealers have interacting effects on postoperative pain. The findings may help clinicians select irrigation agitation techniques and root canal sealers that support patient comfort and improve the patient experience following root canal treatment.
Read the detailed description
This randomized clinical trial is designed to evaluate the effects of different irrigation agitation techniques and root canal sealers on postoperative pain and oral health-related quality of life in patients with symptomatic irreversible pulpitis. The study will compare six treatment combinations involving three irrigation agitation techniques and two root canal sealers. It will also investigate whether the two treatment factors have interacting effects on postoperative pain.
Study Design The study will be conducted as a randomized clinical trial with a 3 × 2 factorial design and six treatment groups. A total of 324 participants will be allocated equally to the groups, with 54 participants per group. Root canal treatment will be completed in a single visit by the same clinician using standardized clinical procedures.
A computer-generated randomization sequence prepared by an independent researcher will be used to assign participants to the treatment groups. The treating clinician cannot be blinded because of the differences between the irrigation agitation techniques and sealers. Statistical analysis will be performed by a researcher blinded to group identities using coded treatment groups.
Participants Participants will be adults aged 18-65 years who require primary root canal treatment of a single-rooted, single-canal permanent tooth diagnosed with symptomatic irreversible pulpitis. Eligible teeth must show no evidence of apical pathology on periapical radiographs. Participants must be able to complete the patient-reported assessment tools and provide written informed consent before enrollment.
Exclusion criteria will include analgesic or antibiotic use within the preceding 48 hours, pregnancy or breastfeeding, periodontal disease, cracked teeth, internal resorption, and previous endodontic treatment of the study tooth.
Interventions
All participants will undergo root canal treatment using standardized procedures for local anesthesia, isolation, canal preparation, irrigation, and obturation. Participants will receive one of the following treatment combinations:
- XP-Endo Finisher irrigation agitation with AH Plus.
- EDDY sonic irrigation agitation with AH Plus.
- Passive ultrasonic activation with AH Plus.
- XP-Endo Finisher irrigation agitation with NeoSealer Flo.
- EDDY sonic irrigation agitation with NeoSealer Flo.
- Passive ultrasonic activation with NeoSealer Flo. AH Plus is an epoxy resin-based root canal sealer, whereas NeoSealer Flo is a calcium silicate-based root canal sealer. The assigned irrigation agitation technique will be used during the irrigation stage, and the assigned sealer will be used during root canal obturation.
Follow-up and Pain Assessment Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. Participants will record their pain intensity at 6, 12, 24, 48, and 72 hours and 7 days after completion of treatment using standardized follow-up forms.
Analgesic use during the seven-day follow-up period will also be recorded. Appropriate analgesic treatment will be provided when clinically indicated.
Oral Health-Related Quality of Life Assessment Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire before treatment and 7 days after treatment. The questionnaire contains 14 items addressing the impact of oral conditions on daily functioning and well-being. Higher scores indicate a greater adverse impact on oral health-related quality of life. Changes from baseline to day 7 will be compared among the treatment groups.
Outcome Measures The primary outcome measure will be postoperative pain intensity assessed using the VAS at the specified follow-up time points.
Secondary outcome measures will include changes in OHIP-14 scores from baseline to 7 days after treatment and analgesic consumption during the postoperative follow-up period. The relationship between postoperative pain and oral health-related quality of life will also be examined.
Study Objective The primary objective is to compare the effects of XP-Endo Finisher, EDDY, and passive ultrasonic activation, each used with either AH Plus or NeoSealer Flo, on postoperative pain in patients with symptomatic irreversible pulpitis. Additional objectives are to evaluate oral health-related quality of life, analgesic consumption, and the interaction between irrigation agitation technique and root canal sealer.
The findings may provide clinically relevant evidence to guide treatment selection and improve patient comfort following root canal treatment.
- Conditions
- Postoperative Pain After Endodontic Treatment, Oral Health-Related Quality of Life, Symptomatic Irreversible Pulpitis, Endodontic Treatment
- Being tested
- XP-Endo Finisher, EDDY, Passive Ultrasonic Activation, AH Plus, NeoSealer Flo
- Keywords
- Symptomatic Irreversible Pulpitis, Postoperative Pain, Irrigation Agitation, Oral Health-Related Quality of Life
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XP-Endo FinisherDrug
XP-Endo Finisher will be used to agitate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.
EDDYDrug
EDDY will be used for sonic agitation of the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.
Passive Ultrasonic ActivationDrug
Passive ultrasonic activation will be used to activate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.
AH PlusDrug
AH Plus, an epoxy resin-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique.
NeoSealer FloDrug
NeoSealer Flo, a calcium silicate-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique.
| Study group | Role | What they receive |
|---|---|---|
| XP-Endo Finisher + AH Plus | Experimental | Participants will receive single-visit root canal treatment with XP-Endo Finisher irrigation agitation, followed by root canal obturation using the epoxy resin-based sealer AH Plus. Receives: Drug: XP-Endo Finisher; Drug: AH Plus |
| EDDY + AH Plus | Experimental | Participants will receive single-visit root canal treatment with EDDY sonic irrigation agitation, followed by root canal obturation using the epoxy resin-based sealer AH Plus. Receives: Drug: EDDY; Drug: AH Plus |
| Passive Ultrasonic Activation + AH Plus | Experimental | Participants will receive single-visit root canal treatment with passive ultrasonic activation of the irrigant, followed by root canal obturation using the epoxy resin-based sealer AH Plus. Receives: Drug: Passive Ultrasonic Activation; Drug: AH Plus |
| XP-Endo Finisher + NeoSealer Flo | Experimental | Participants will receive single-visit root canal treatment with XP-Endo Finisher irrigation agitation, followed by root canal obturation using the calcium silicate-based sealer NeoSealer Flo. Receives: Drug: XP-Endo Finisher; Drug: NeoSealer Flo |
| EDDY + NeoSealer Flo | Experimental | Participants will receive single-visit root canal treatment with EDDY sonic irrigation agitation, followed by root canal obturation using the calcium silicate-based sealer NeoSealer Flo. Receives: Drug: EDDY; Drug: NeoSealer Flo |
| Passive Ultrasonic Activation + NeoSealer Flo | Experimental | Participants will receive single-visit root canal treatment with passive ultrasonic activation of the irrigant, followed by root canal obturation using the calcium silicate-based sealer NeoSealer Flo. Receives: Drug: Passive Ultrasonic Activation; Drug: NeoSealer Flo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using a patient-reported Visual Analog Scale (VAS). The VAS consists of a 10-cm line anchored at 0 cm ("no pain") and 10 cm ("worst imaginable pain"). Participants will mark their pain intensity on the line. Scores will range from 0 to 10, with higher scores indicating greater pain intensity. The measurement unit will be the VAS score.
Measured: 6, 12, 24, 48, and 72 hours and 7 days after completion of root canal treatment.
Secondary outcomes (2)
Change in Oral Health-Related Quality of Life
Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire before treatment and 7 days after treatment. The questionnaire consists of 14 items, each scored from 0 ("never") to 4 ("very often"), yielding a total score ranging from 0 to 56. Higher scores indicate a greater adverse impact on oral health-related quality of life. Change will be calculated as the day-7 score minus the baseline score; negative values indicate improvement.
Measured: Baseline (before treatment) and 7 days after completion of root canal treatment.
Analgesic Consumption
Analgesic use for postoperative pain control will be recorded during the seven-day follow-up period and compared among the six treatment groups.
Measured: Within 7 days after completion of root canal treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start13 Nov 2026 (estimated)
- Primary completion16 Feb 2027 (estimated)
- Study completion23 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain After Endodontic TreatmentStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Model description
- Participants are randomly assigned to one of six treatment groups in a 3 × 2 factorial design combining three irrigation agitation techniques (XP-Endo Finisher, EDDY, and passive ultrasonic activation) with two root canal sealers (AH Plus and NeoSealer Flo). Each group includes 54 participants, for a total of 324 participants. Each participant receives only one treatment combination, and root canal treatment is completed in a single visit. Postoperative pain, oral health-related quality of life, and analgesic use are evaluated over the same seven-day follow-up period and compared among the groups to assess the effects of each treatment factor and their interaction.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assist.Prof.Emine ODABAŞI TEZER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859384
- Sponsor's protocol ID
- 16-769-26
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and confidentiality considerations.
Publications
Hatipoglu FP, Oksuzer MC, Karobari MI, Hatipoglu O. Determining the optimal irrigation activation or agitation techniques for postoperative pain control: A network meta-regression of clinical trials. Jpn Dent Sci Rev. 2026 Dec;62:26-45. doi: 10.1016/j.jdsr.2025.12.001. Epub 2025 Dec 18.
PubMed 41510144Ensinas P, Aranguren J, Tosco V, Franco C, Pineda K, Malvicini G, Perez AR. The Impact of Calcium Silicate-Based and Resin-Based Root Canal Sealers on Postoperative Pain and Sealer Extrusion: A Multicenter Randomized Clinical Study. J Endod. 2025 Nov;51(11):1508-1518. doi: 10.1016/j.joen.2025.07.004. Epub 2025 Jul 11.
PubMed 40653154Ustun Y, Eraslan Akyuz I, Manolya Ozdemir I. Effects of Different Root Canal Sealers and Irrigation Agitation Methods on Postoperative Pain in the Treatment of Teeth with Chronic Apical Periodontitis: A Randomized Clinical Trial. J Endod. 2026 Feb;52(2):227-238. doi: 10.1016/j.joen.2025.09.015. Epub 2025 Oct 1.
PubMed 41043607
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Root Canal Filling Materials and Irrigation Agitation Techniques on Postoperative Pain in Teeth With Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07859384
- Acronym / sponsor ID
- 16-769-26
- Conditions
- Postoperative Pain After Endodontic Treatment, Oral Health-Related Quality of Life, Symptomatic Irreversible Pulpitis, Endodontic Treatment
- Keywords
- Symptomatic Irreversible Pulpitis, Postoperative Pain, Irrigation Agitation, Oral Health-Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 13 Nov 2026 (estimated)
- Primary completion
- 16 Feb 2027 (estimated)
- Study completion
- 23 Feb 2027 (estimated)
- First posted
- 5 Oct 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.
This clinical study is designed to evaluate the effects of different irrigation agitation techniques and root canal sealers on postoperative pain and oral health-related quality of life in patients with symptomatic irreversible pulpitis. Postoperative pain following root canal treatment may affect patient comfort and satisfaction. The choice of irrigation agitation technique and root canal sealer may influence these outcomes. Irrigation agitation techniques are used to improve cleaning of the root canal system. XP-Endo Finisher, EDDY, and passive ultrasonic activation use different mechanisms to enhance this process. Root canal sealers, including the epoxy resin-based AH Plus and the calcium silicate-based NeoSealer Flo, also differ in their composition and biological properties. Clinical evidence regarding the combined effects of these techniques and sealers on patient-reported outcomes remains limited. In this randomized clinical trial, 324 patients aged 18-65 years requiring root canal treatment for a single-rooted, single-canal permanent tooth with symptomatic irreversible pulpitis will be allocated to six groups. Each group will receive one of three irrigation agitation techniques-XP-Endo Finisher, EDDY, or passive ultrasonic activation-in combination with either AH Plus or NeoSealer Flo. Root canal treatment will be completed in a single visit. Postoperative pain intensity will be assessed using a visual analog scale at 6, 12, 24, 48, and 72 hours and 7 days after treatment. Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 questionnaire before treatment and 7 days afterward. Analgesic use during the follow-up period will also be recorded. The primary objective is to compare postoperative pain among the six treatment groups. Secondary objectives include evaluating changes in oral health-related quality of life and analgesic consumption. The study will also investigate whether irrigation agitation techniques and root canal sealers have interacting effects on postoperative pain. The findings may help clinicians select irrigation agitation techniques and root canal sealers that support patient comfort and improve the patient experience following root canal treatment.
Detailed description
This randomized clinical trial is designed to evaluate the effects of different irrigation agitation techniques and root canal sealers on postoperative pain and oral health-related quality of life in patients with symptomatic irreversible pulpitis. The study will compare six treatment combinations involving three irrigation agitation techniques and two root canal sealers. It will also investigate whether the two treatment factors have interacting effects on postoperative pain.
Study Design The study will be conducted as a randomized clinical trial with a 3 × 2 factorial design and six treatment groups. A total of 324 participants will be allocated equally to the groups, with 54 participants per group. Root canal treatment will be completed in a single visit by the same clinician using standardized clinical procedures.
A computer-generated randomization sequence prepared by an independent researcher will be used to assign participants to the treatment groups. The treating clinician cannot be blinded because of the differences between the irrigation agitation techniques and sealers. Statistical analysis will be performed by a researcher blinded to group identities using coded treatment groups.
Participants Participants will be adults aged 18-65 years who require primary root canal treatment of a single-rooted, single-canal permanent tooth diagnosed with symptomatic irreversible pulpitis. Eligible teeth must show no evidence of apical pathology on periapical radiographs. Participants must be able to complete the patient-reported assessment tools and provide written informed consent before enrollment.
Exclusion criteria will include analgesic or antibiotic use within the preceding 48 hours, pregnancy or breastfeeding, periodontal disease, cracked teeth, internal resorption, and previous endodontic treatment of the study tooth.
Interventions
All participants will undergo root canal treatment using standardized procedures for local anesthesia, isolation, canal preparation, irrigation, and obturation. Participants will receive one of the following treatment combinations:
- XP-Endo Finisher irrigation agitation with AH Plus.
- EDDY sonic irrigation agitation with AH Plus.
- Passive ultrasonic activation with AH Plus.
- XP-Endo Finisher irrigation agitation with NeoSealer Flo.
- EDDY sonic irrigation agitation with NeoSealer Flo.
- Passive ultrasonic activation with NeoSealer Flo. AH Plus is an epoxy resin-based root canal sealer, whereas NeoSealer Flo is a calcium silicate-based root canal sealer. The assigned irrigation agitation technique will be used during the irrigation stage, and the assigned sealer will be used during root canal obturation.
Follow-up and Pain Assessment Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. Participants will record their pain intensity at 6, 12, 24, 48, and 72 hours and 7 days after completion of treatment using standardized follow-up forms.
Analgesic use during the seven-day follow-up period will also be recorded. Appropriate analgesic treatment will be provided when clinically indicated.
Oral Health-Related Quality of Life Assessment Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire before treatment and 7 days after treatment. The questionnaire contains 14 items addressing the impact of oral conditions on daily functioning and well-being. Higher scores indicate a greater adverse impact on oral health-related quality of life. Changes from baseline to day 7 will be compared among the treatment groups.
Outcome Measures The primary outcome measure will be postoperative pain intensity assessed using the VAS at the specified follow-up time points.
Secondary outcome measures will include changes in OHIP-14 scores from baseline to 7 days after treatment and analgesic consumption during the postoperative follow-up period. The relationship between postoperative pain and oral health-related quality of life will also be examined.
Study Objective The primary objective is to compare the effects of XP-Endo Finisher, EDDY, and passive ultrasonic activation, each used with either AH Plus or NeoSealer Flo, on postoperative pain in patients with symptomatic irreversible pulpitis. Additional objectives are to evaluate oral health-related quality of life, analgesic consumption, and the interaction between irrigation agitation technique and root canal sealer.
The findings may provide clinically relevant evidence to guide treatment selection and improve patient comfort following root canal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Participants are randomly assigned to one of six treatment groups in a 3 × 2 factorial design combining three irrigation agitation techniques (XP-Endo Finisher, EDDY, and passive ultrasonic activation) with two root canal sealers (AH Plus and NeoSealer Flo). Each group includes 54 participants, for a total of 324 participants. Each participant receives only one treatment combination, and root canal treatment is completed in a single visit. Postoperative pain, oral health-related quality of life, and analgesic use are evaluated over the same seven-day follow-up period and compared among the groups to assess the effects of each treatment factor and their interaction.
| Arm | Type | Receives |
|---|---|---|
| XP-Endo Finisher + AH Plus | Experimental | Drug: XP-Endo Finisher, Drug: AH PlusParticipants will receive single-visit root canal treatment with XP-Endo Finisher irrigation agitation, followed by root canal obturation using the epoxy resin-based sealer AH Plus. |
| EDDY + AH Plus | Experimental | Drug: EDDY, Drug: AH PlusParticipants will receive single-visit root canal treatment with EDDY sonic irrigation agitation, followed by root canal obturation using the epoxy resin-based sealer AH Plus. |
| Passive Ultrasonic Activation + AH Plus | Experimental | Drug: Passive Ultrasonic Activation, Drug: AH PlusParticipants will receive single-visit root canal treatment with passive ultrasonic activation of the irrigant, followed by root canal obturation using the epoxy resin-based sealer AH Plus. |
| XP-Endo Finisher + NeoSealer Flo | Experimental | Drug: XP-Endo Finisher, Drug: NeoSealer FloParticipants will receive single-visit root canal treatment with XP-Endo Finisher irrigation agitation, followed by root canal obturation using the calcium silicate-based sealer NeoSealer Flo. |
| EDDY + NeoSealer Flo | Experimental | Drug: EDDY, Drug: NeoSealer FloParticipants will receive single-visit root canal treatment with EDDY sonic irrigation agitation, followed by root canal obturation using the calcium silicate-based sealer NeoSealer Flo. |
| Passive Ultrasonic Activation + NeoSealer Flo | Experimental | Drug: Passive Ultrasonic Activation, Drug: NeoSealer FloParticipants will receive single-visit root canal treatment with passive ultrasonic activation of the irrigant, followed by root canal obturation using the calcium silicate-based sealer NeoSealer Flo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Patients with single-rooted teeth requiring endodontic retreatment.
Key exclusion criteria (4 listed)
- Patients who have used antibiotics or analgesic medications within the last month.
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 |
|---|---|---|
| XP-Endo FinisherXP-Endo Finisher will be used to agitate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis. | Drug | XP-Endo Finisher + AH Plus, XP-Endo Finisher + NeoSealer Flo |
| EDDYEDDY will be used for sonic agitation of the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis. | Drug | EDDY + AH Plus, EDDY + NeoSealer Flo |
| Passive Ultrasonic ActivationPassive ultrasonic activation will be used to activate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis. | Drug | Passive Ultrasonic Activation + AH Plus, Passive Ultrasonic Activation + NeoSealer Flo |
| AH PlusAH Plus, an epoxy resin-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique. | Drug | EDDY + AH Plus, Passive Ultrasonic Activation + AH Plus, XP-Endo Finisher + AH Plus |
| NeoSealer FloNeoSealer Flo, a calcium silicate-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique. | Drug | EDDY + NeoSealer Flo, Passive Ultrasonic Activation + NeoSealer Flo, XP-Endo Finisher + NeoSealer Flo |
Primary outcome
Postoperative Pain Intensity
Time frame: 6, 12, 24, 48, and 72 hours and 7 days after completion of root canal treatment.
Postoperative pain intensity will be assessed using a patient-reported Visual Analog Scale (VAS). The VAS consists of a 10-cm line anchored at 0 cm ("no pain") and 10 cm ("worst imaginable pain"). Participants will mark their pain intensity on the line. Scores will range from 0 to 10, with higher scores indicating greater pain intensity. The measurement unit will be the VAS score.
2 secondary outcomes
Change in Oral Health-Related Quality of Life
Time frame: Baseline (before treatment) and 7 days after completion of root canal treatment.
Analgesic Consumption
Time frame: Within 7 days after completion of root canal treatment.
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 5 Oct 2026.
- Background: PubMed 41510144Hatipoglu FP, Oksuzer MC, Karobari MI, Hatipoglu O. Determining the optimal irrigation activation or agitation techniques for postoperative pain control: A network meta-regression of clinical trials. Jpn Dent Sci Rev. 2026 Dec;62:26-45. doi: 10.1016/j.jdsr.2025.12.001. Epub 2025 Dec 18.
- Background: PubMed 40653154Ensinas P, Aranguren J, Tosco V, Franco C, Pineda K, Malvicini G, Perez AR. The Impact of Calcium Silicate-Based and Resin-Based Root Canal Sealers on Postoperative Pain and Sealer Extrusion: A Multicenter Randomized Clinical Study. J Endod. 2025 Nov;51(11):1508-1518. doi: 10.1016/j.joen.2025.07.004. Epub 2025 Jul 11.
- Background: PubMed 41043607Ustun Y, Eraslan Akyuz I, Manolya Ozdemir I. Effects of Different Root Canal Sealers and Irrigation Agitation Methods on Postoperative Pain in the Treatment of Teeth with Chronic Apical Periodontitis: A Randomized Clinical Trial. J Endod. 2026 Feb;52(2):227-238. doi: 10.1016/j.joen.2025.09.015. Epub 2025 Oct 1.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and confidentiality considerations.
Related trials for Postoperative Pain After Endodontic Treatment
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Recruiting
Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
Apical Periodontitis, Postoperative Pain After Endodontic Treatment
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
Not yet recruiting
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
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 study testing XP-Endo Finisher, EDDY and Passive Ultrasonic Activation in people with Postoperative Pain After Endodontic Treatment and Oral Health-Related Quality of Life, run by Ankara 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Oct 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.
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 Emine ODABAŞI TEZER, DDS (+90 505 303 93 96, emiodabasi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: 6, 12, 24, 48, and 72 hours and 7 days after completion of root canal treatment.). 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 NCT07859384, which also lists 3 linked publications.
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 5 Oct 2026.