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

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:

1. XP-Endo Finisher irrigation agitation with AH Plus.
2. EDDY sonic irrigation agitation with AH Plus.
3. Passive ultrasonic activation with AH Plus.
4. XP-Endo Finisher irrigation agitation with NeoSealer Flo.
5. EDDY sonic irrigation agitation with NeoSealer Flo.
6. 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.