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Recruiting Not applicable

Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth

NCT07868315 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-04-22
Last updated
2026-10-09

Condition(s) studied

Single-visitPeriapical Periodontitis

Investigational drug(s) / intervention(s)

One-FillTotalFillAH Plus + Single ConeAH Plus + Continuous Wave

One-Fill: Root canal obturation using One-Fill bioceramic sealer with a single-cone technique. The prepared root canal is filled with a fitted gutta-percha cone coated with One-Fill sealer according to the manufacturer's instructions.

TotalFill: Root canal obturation using TotalFill BC Sealer with a single-cone technique. The prepared root canal is filled with a fitted gutta-percha cone coated with TotalFill BC Sealer according to the manufacturer's instructions.

AH Plus + Single Cone: Root canal obturation using AH Plus epoxy resin-based sealer with a single-cone technique. A fitted gutta-percha cone is coated with AH Plus sealer and placed to the working length according to the study protocol.

AH Plus + Continuous Wave: Root canal obturation using AH Plus epoxy resin-based sealer with the continuous wave of condensation technique. The master gutta-percha cone is fitted to the working length, followed by down-pack and backfill procedures using heated gutta-percha according to the study protocol.

Study summary

This study evaluates the postoperative pain and long-term clinical and radiographic success of single-visit primary root canal treatment in asymptomatic teeth with periapical lesions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Patients aged 18-65 years. * Patients classified as ASA Physical Status I or II according to the American Society of Anesthesiologists (ASA) classification: * Teeth that have not previously undergone root canal retreatment or surgical intervention. * Patients who are able to read and sign the informed consent form. * Patients who are physically and mentally able to tolerate the planned dental treatment. * Teeth treated in a single treatment session. Exclusion Criteria: * Pregnant or lactating women. * Patients with chronic periodontal disease and/or a periodontal probing depth \>4 mm. * Symptomatic patients. * Patients who are unable to comply with the scheduled follow-up periods. * Patients who have used analgesics within 1 week or antibiotics within 1 month prior to treatment. * Teeth with root resorption. * Teeth with a vertical root fracture or a risk of vertical root fracture. * Teeth with incomplete root development.

Primary outcome measure(s)

  • Postoperative Pain — 6 hours, 24 hours, 48 hours, 72 hours, 1 week, 1 month after root canal treatment.
    Postoperative pain following single-session primary root canal treatment, assessed using a 10-point visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. higher scores indicate greater pain intensity.
  • Clinical Success and Radiographic Radiographic Changes in Periapical Lesion Size Following Root Canal Treatment — 1 months / 3 months /6 months / 12 months
    Radiographic assessment of periapical lesion size following single-session primary root canal treatment. Periapical lesion size will be measured on digital periapical radiographs using image analysis software. A coin of known diameter will be used as a radiographic calibration reference to standardize measurements. The maximum diameter of the periapical radiolucency will be measured in millimeters (mm) at each follow-up examination (1, 3, 6, and 12 months). Changes in lesion size will be calculated by comparing measurements obtained at baseline and subsequent follow-up examinations.

Trial sites (1)

FacilityCityRegionStatus
Istanbul Medipol University, Faculty of Dentistry Istanbul Esenler Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07868315 on ClinicalTrials.gov ↗ ← All trials in Turkey