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ACTIVE NOT RECRUITING
NCT07907367

A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste

Sponsor: The Affiliated Hospital of Jinggangshan University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

10 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2024-06-08

Completion Date

2028-10-01

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

OTHER

Vitapex Paste

Vitapex calcium hydroxide paste used for root canal disinfection during routine endodontic treatment

Locations (1)

Jinggangshan University Affiliated Hospital

Ji’an, Jiangxi, China