An interventional study of One-Fill and TotalFill in Single-visit and Periapical Periodontitis, sponsored by Istanbul Medipol University Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment
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.
A total of 200 patients will be evaluated and divided into four treatment groups according to the root canal filling material and technique: AH Plus with warm gutta-percha, AH Plus with the single-cone technique, TotalFill BC Sealer with the single-cone technique, and One-Fil with the single-cone technique. Postoperative pain will be assessed, while periapical healing will be evaluated clinically and radiographically using the Periapical Index (PAI) during follow-up visits extending from 1 month to 1 year. The study aims to compare different root canal sealers and obturation techniques and contribute to the understanding of their long-term treatment outcomes.
256 studies on the registry are indexed under Periapical Periodontitis; 65 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 222 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Istanbul Medipol University Hospital is the lead sponsor of 365 studies on the registry; 59 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Root canal obturation using One Fill root canal sealer according to the manufacturer's instructions.
Other: One-Fill
Root canal obturation using TotalFill root canal sealer according to the manufacturer's instructions.
Other: TotalFill
Root canal obturation using AH Plus root canal sealer in combination with a single-cone obturation technique.
Other: AH Plus + Single Cone
Root canal obturation using AH Plus root canal sealer in combination with a continuous-wave obturation technique.
Other: AH Plus + Continuous Wave
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.
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.
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.
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.
Postoperative Pain
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.
Time frame: 6 hours, 24 hours, 48 hours, 72 hours, 1 week, 1 month after root canal treatment.
Clinical Success and Radiographic Radiographic Changes in Periapical Lesion Size Following Root Canal Treatment
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.
Time frame: 1 months / 3 months /6 months / 12 months
Plan to share: Yes — After its publication in a journal, the investigators want to share their data.
Supporting information: Study protocol, Statistical analysis plan
Time frame: After its publication in a journal, the investigators want to share their data.
Access criteria: Postoperative pain scores, radiographic and clinical findings.
Started Apr 2025 (actual). Primary completion is estimated for Nov 2026, 18 months after the start.
Of 151 non-industry interventional studies with no phase under Periapical Periodontitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 18 months is above that.
Counting every sponsor, half of 152 studies reached it within 12 months; a quarter within 6 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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