Effects of Different Root Canal Filling Materials and Irrigation Agitation Techniques on Postoperative Pain in Teeth With Irreversible Pulpitis: A Randomized Clinical Trial

NCT07859384 | Not Yet Recruiting

• 1 other identifier: 16-769-26
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline (before treatment) and 7 days after completion of root canal treatment.

• Analgesic Consumption

  Within 7 days after completion of root canal treatment.

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: Passive Ultrasonic Activation; Drug: NeoSealer Flo

Interventions

XP-Endo Finisher DRUG

XP-Endo Finisher will be used to agitate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.

XP-Endo Finisher + AH Plus; XP-Endo Finisher + NeoSealer Flo

EDDY DRUG

EDDY will be used for sonic agitation of the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.

EDDY + AH Plus; EDDY + NeoSealer Flo

Passive Ultrasonic Activation DRUG

Passive ultrasonic activation will be used to activate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.

Passive Ultrasonic Activation + AH Plus; Passive Ultrasonic Activation + NeoSealer Flo

AH Plus DRUG

AH Plus, an epoxy resin-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique.

EDDY + AH Plus; Passive Ultrasonic Activation + AH Plus; XP-Endo Finisher + AH Plus

NeoSealer Flo DRUG

NeoSealer Flo, a calcium silicate-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique.

EDDY + NeoSealer Flo; Passive Ultrasonic Activation + NeoSealer Flo; XP-Endo Finisher + NeoSealer Flo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 41510144 BACKGROUND

• 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.

  PMID: 40653154 BACKGROUND

• 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.

  PMID: 41043607 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

epoxy resin-based root canal sealer

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Emine ODABAŞI TEZER, DDS

CONTACT

+90 505 303 93 96; emiodabasi@gmail.com

ÖZGE KURT KAYA

CONTACT

+90 5457737969; Ozgekrtrs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The researcher performing the statistical analysis will be blinded to treatment assignments. The six treatment groups will be coded, and their identities will remain concealed from the researcher during data analysis. The treating clinician will not be blinded because of the differences between the irrigation agitation techniques and root canal sealers. Postoperative pain and oral health-related quality of life will be assessed using questionnaires completed by participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 5, 2026
• Study Start (Estimated): November 13, 2026
• Primary Completion (Estimated): February 16, 2027
• Study Completion (Estimated): February 23, 2027
• Last Updated: October 5, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)