Periapical PeriodontitisNCT07907367
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
An observational study of Periapical Periodontitis and Periapical Abscess, run by The Affiliated Hospital of Jinggangshan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Periapical Periodontitis, Periapical Abscess, Periapical Radiolucency
- What is being tested?
- Vitapex Paste
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2024to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Age between 10 and 80 years.Radiographic diagnosis of periapical periodontitis with obvious bone destruction.Radiographic evidence of periapical bone destruction with the maximum lesion diameter over 4 mm.No systemic diseases affecting bone metabolism.No known allergy to calcium hydroxide or iodoform.Patients treated entirely with non-surgical root canal therapy without apical surgery.
Who cannot join
- Pregnant or lactating women.Severe tooth structure damage that cannot be restored.Missing follow-up data or patients lost to follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Vitapex Paste
- Keywords
- Vitapex, Non-surgical Root Canal Treatment, Retrospective Cohort Study
- Medical subject headings
- Periapical Periodontitis, Periapical Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitapex PasteOther
Vitapex calcium hydroxide paste used for root canal disinfection during routine endodontic treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start8 Jun 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Jinggangshan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Yun, The Affiliated Hospital of Jinggangshan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907367
- Sponsor's protocol ID
- JGSU-VITA-2026-001
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
- ClinicalTrials.gov ID
- NCT07907367
- Acronym / sponsor ID
- JGSU-VITA-2026-001
- Keywords
- Vitapex, Non-surgical Root Canal Treatment, Retrospective Cohort Study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Jinggangshan UniversityUniversity, hospital or other
- Study start
- 8 Jun 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Age between 10 and 80 years.Radiographic diagnosis of periapical periodontitis with obvious bone destruction.Radiographic evidence of periapical bone destruction with the maximum lesion diameter over 4 mm.No systemic diseases affecting bone metabolism.No known allergy to calcium hydroxide or iodoform.Patients treated entirely with non-surgical root canal therapy without apical surgery.
Key exclusion criteria (1 listed)
- Pregnant or lactating women.Severe tooth structure damage that cannot be restored.Missing follow-up data or patients lost to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitapex PasteVitapex calcium hydroxide paste used for root canal disinfection during routine endodontic treatment | Other | – |
Primary outcome
Changes in Inflammatory Volume
Time frame: 24 Months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periapical Periodontitis and Periapical Abscess, run by The Affiliated Hospital of Jinggangshan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Inflammatory Volume (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.