An observational study in Periapical Periodontitis, Periapical Abscess and Periapical Radiolucency, sponsored by The Affiliated Hospital of Jinggangshan University. Active, not recruiting at 1 site in China. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by The Affiliated Hospital of Jinggangshan University · Observational
Background: Periapical inflammation is a common clinical condition, classified into periapical periodontitis, periapical granuloma, and periapical cyst. When the inflammatory mass is too large, root canal therapy alone is often insufficient to control the inflammation, and treatment typically requires a combination of surgical procedures. Studies have shown that delivering Vitapex paste through prepared root canals to the periapical inflammatory site can cause the inflammation to spontaneously subside or even resolve completely; however, there is currently limited research on this treatment approach.
Objective: This study aims to treat apical inflammation using Vitapex paste, monitor changes in apical inflammation, determine the efficacy of Vitapex paste in treating periapical periodontitis, and provide a theoretical basis for this treatment method.
Methods: This study employed a retrospective cohort design, and plans to enroll patients diagnosed with periapical inflammation and showing a distinct periapical shadow at the Department of Stomatology, Jinggangshan University Affiliated Hospital, between February 2025 and December 2027. Following conventional root canal preparation, Vitapex paste will be delivered to the site of periapical inflammation, and CBCT images will be collected at 6, 12, 18, and 24 months post-treatment to monitor changes in the volume of inflammation. Complete resolution of inflammation or a reduction in inflammation volume of more than 50% will be considered a success; a reduction of less than 50% will be considered a failure. If the success rate exceeds 80%, this will indicate that the use of Vitapex as a non-surgical treatment for controlling periapical inflammation is effective, thereby avoiding surgical intervention, minimizing patient trauma, and reducing treatment costs.
280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.
This study's planned enrollment of 80 is close to the median of 88 across 33 observational studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →This is the only study on the registry with The Affiliated Hospital of Jinggangshan University as lead sponsor.
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The study population consists of patients with periapical periodontitis who received non-surgical root canal therapy with Vitapex paste at the Department of Stomatology, Jinggangshan University Affiliated Hospital, between June 2024 and June 2026. Only patients with complete medical records and CBCT imaging data will be included in the final analysis.
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Exclusion Criteria:
Pregnant or lactating women.Severe tooth structure damage that cannot be restored.Missing follow-up data or patients lost to follow-up.
Vitapex calcium hydroxide paste used for root canal disinfection during routine endodontic treatment
Changes in Inflammatory Volume
CBCT imaging data were collected from patients before surgery and at 6, 12, 18, and 24 months postoperatively. The 3D-Slicer software was used to perform three-dimensional reconstruction and volume calculation of the inflammatory areas. Two investigators measured the volumes independently, and the average value was calculated. The volumes of the periapical cysts were compared, and the rate of volume reduction was calculated. Complete resolution of the cyst or a volume reduction of more than 50% was considered a success, while a reduction of less than 50% or no significant change was considered a failure.
Time frame: 24 Months
Started Jun 2024 (actual). Primary completion is estimated for Oct 2027, 39 months after the start.
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 ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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