Effects of Different Root Canal Filling Materials and Irrigation Agitation Techniques on Postoperative Pain in Teeth With Irreversible Pulpitis: A Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emine ODABAŞI TEZER, DDS
- Phone Number: +90 505 303 93 96
- Email: emiodabasi@gmail.com
Study Contact Backup
- Name: ÖZGE KURT KAYA
- Phone Number: +90 5457737969
- Email: Ozgekrtrs@gmail.com
Study Locations
-
-
Ankara
-
Ankara, Ankara, Turkey (Türkiye), 06100
- Ankara University Faculty of Dentistry
-
Contact:
- Assistant Professor
- Phone Number: +90 505 303 93 96
- Email: emiodabasi@gmail.com
-
Principal Investigator:
- Emine ODABAŞI TEZER, DDS
-
Contact:
- ÖZGE KURT KAYA, DDS
- Phone Number: +90 5457737969
- Email: Ozgekrtrs@gmail.com
-
Sub-Investigator:
- ÖZGE KURT KAYA, DDS
-
Sub-Investigator:
- Elif SOLAKOĞLU, DDS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-
• 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.
Exclusion Criteria:
-
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: XP-Endo Finisher + AH Plus
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. |
XP-Endo Finisher will be used to agitate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis. AH Plus, an epoxy resin-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique. |
|
Experimental: EDDY + AH Plus
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. |
AH Plus, an epoxy resin-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique. EDDY will be used for sonic agitation of the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis. |
|
Experimental: Passive Ultrasonic Activation + AH Plus
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. |
AH Plus, an epoxy resin-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique. Passive ultrasonic activation will be used to activate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis. |
|
Experimental: XP-Endo Finisher + NeoSealer Flo
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. |
XP-Endo Finisher will be used to agitate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis. NeoSealer Flo, a calcium silicate-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique. |
|
Experimental: EDDY + NeoSealer Flo
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. |
EDDY will be used for sonic agitation of the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis. NeoSealer Flo, a calcium silicate-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique. |
|
Experimental: Passive Ultrasonic Activation + NeoSealer Flo
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. |
Passive ultrasonic activation will be used to activate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis. NeoSealer Flo, a calcium silicate-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
6, 12, 24, 48, and 72 hours and 7 days after completion of root canal treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Oral Health-Related Quality of Life
Time Frame: Baseline (before treatment) and 7 days after completion of root canal treatment.
|
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. |
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.
|
Analgesic use for postoperative pain control will be recorded during the seven-day follow-up period and compared among the six treatment groups. |
Within 7 days after completion of root canal treatment.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Ensinas 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.
- Ustun 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-769-26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared due to ethical and confidentiality considerations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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