This randomized controlled clinical study will evaluate the effects of intracanal cryotherapy during root canal treatment in patients with asymptomatic apical periodontitis. The study will investigate whether the temperature of the final irrigation solution influences the biological inflammatory response and postoperative pain.
Participants will be randomly assigned to one of three groups according to the temperature of distilled water used for final root canal irrigation: 2-4°C, 8-10°C, or 22-24°C. Periapical tissue fluid samples will be collected before and after the intervention and analyzed for inflammatory and tissue-response biomarkers, including IL-1β, TNF-α, RANKL/OPG, PGE2, TGF-β, and MMP-9. Postoperative pain and analgesic use will also be recorded during the first 7 days after treatment.
The study aims to determine whether intracanal cryotherapy can reduce the inflammatory response and postoperative pain associated with root canal treatment and whether these effects vary according to the temperature of the irrigation solution.
Age between 18 and 65 years.
Presence of a posterior tooth indicated for primary endodontic treatment (excluding retreatment cases).
Necrotic pulp based on pulp vitality testing (negative cold test and/or electrical pulp test [EPT]).
Periapical Index (PAI) ≥3 on periapical radiography or presence of periapical radiolucency on cone-beam computed tomography (CBCT).
Use of antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), or -corticosteroids within the previous 3 months.
Presence of a systemic inflammatory or autoimmune disease.
Diabetes (glycated hemoglobin [HbA1c] ≥6.5%) or uncontrolled metabolic disease.
History of immunodeficiency or immunosuppressive therapy.
Parallel
Temperature-Controlled Intracanal Irrigation
Procedure/SurgeryParticipants will receive temperature-controlled distilled-water intracanal irrigation during root canal treatment. According to computer-generated randomization, participants will be assigned to one of three irrigation-temperature groups: 2-4°C, 8-10°C, or 22-24°C. The assigned temperature-controlled distilled-water irrigation protocol will be applied during both treatment sessions. Irrigation conditions will be standardized across groups, with the irrigation temperature being the primary difference between the intervention groups.
Change in Periapical Inflammatory Biomarker Levels
Changes in interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), receptor activator of nuclear factor kappa-B ligand (RANKL), osteoprotegerin (OPG), prostaglandin E2 (PGE2), transforming growth factor-beta (TGF-β), and matrix metalloproteinase-9 (MMP-9) levels in periapical tissue fluid (PTF) will be assessed using enzyme-linked immunosorbent assay (ELISA). Biomarker levels obtained during the first and second treatment sessions will be compared within and between the three irrigation-temperature groups to evaluate the biological response to temperature-controlled intracanal irrigation.
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater postoperative pain intensity. Participants will record their pain intensity after root canal treatment, and scores will be compared among the three irrigation-temperature groups.
Postoperative Analgesic Consumption
Postoperative analgesic consumption will be assessed as the total number of analgesic tablets consumed by each participant during the postoperative follow-up period. Participants will record analgesic use on a daily patient record form. The type and dose of analgesic used will also be documented for descriptive purposes. The total number of tablets consumed will be compared among the three irrigation-temperature groups. Unit of measure: number of tablets.
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Medipol University
Lead sponsor
Istanbul Medipol University Hospital
Sponsor institution
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